Evaluation of an ICT-based Platform for Early Detection and Intervention to Prevent Frailty in Older Adults
Phase: NA
Conditions: Frail Elderly Syndrome, Cognitive Impairment, Physical Dependence
Sponsor: University of Turin, Italy

 
 
 
 
 
 
My Active and Healthy Aging (My-AHA)  
Randomized Control Trial Study  
Protocol 
 
 
 
 
 
 
 

My-AHA RCT Protocol 
 
Table of Contents 
1 
Protocol Flowchart................................................................................................................................... 8 
2 
Recruitment .............................................................................................................................................. 9 
2.1 
Type and Number of Participants .................................................................................................................... 9 
3 
Participant Screening ............................................................................................................................ 10 
3.1 
Inclusion Criteria ............................................................................................................................................. 10 
3.2 
Exclusion Criteria ............................................................................................................................................ 13 
3.3 
Screening Failures ............................................................................................................................................ 16 
3.4 
Withdrawal Criteria ........................................................................................................................................ 16 
3.4.1 
Reasons for Withdrawal ................................................................................................................................................. 16 
3.4.2 
Participant Withdrawal Procedures ................................................................................................................................ 16 
4 
Participant randomization .................................................................................................................... 17 
5 
Devices ..................................................................................................................................................... 18 
6 
Assessment protocol ............................................................................................................................... 19 
6.1 
Overall Design .................................................................................................................................................. 19 
6.2 
Screening questionnaire .................................................................................................................................. 23 
6.3 
Adherence assessment ..................................................................................................................................... 23 
6.4 
Demographic measures ................................................................................................................................... 23 
6.4.1 
Standard demographic questionnaire ............................................................................................................................. 23 
6.4.2 
Brief demographic questionnaire ................................................................................................................................... 23 
6.5 
Health assessment ............................................................................................................................................ 24 
6.5.1 
WHOQol-OLD .............................................................................................................................................................. 24 
6.5.2 
Instrumental Activities of Daily Living (iADL) ............................................................................................................ 24 
6.6 
Physical assessment .......................................................................................................................................... 25 
6.6.1 
Weight............................................................................................................................................................................ 25 
6.6.2 
Height ............................................................................................................................................................................ 25 
6.6.3 
Grip Strength ................................................................................................................................................................. 25 
6.6.4 
Exhaustion (CES-D) ...................................................................................................................................................... 25 
6.6.5 
IPAQ-short version ........................................................................................................................................................ 26 
6.6.6 
6 minute walk test .......................................................................................................................................................... 26 
6.6.7 
Timed up and go test ...................................................................................................................................................... 27 
6.6.8 
Short Physical Performance Battery (SPPB) ................................................................................................................. 28 
6.6.8.1 
Balance test .......................................................................................................................................................... 28 
6.6.8.2 
Gait Speed Test .................................................................................................................................................... 29 
6.6.8.3 
Chair Stand Test ................................................................................................................................................... 29 
6.6.9 
The Activities-specific Balance Confidence (ABC) scale ............................................................................................. 30 
6.6.10 
Physical Activity Enjoyment Scale (PACES) ................................................................................................................ 30 
6.7 
Cognitive assessment ....................................................................................................................................... 31 
6.7.1 
Mini-Mental State Examination (MMSE) ..................................................................................................................... 31 
6.7.2 
Hopkins Verbal Learning Test (HVLT) ......................................................................................................................... 31 

My-AHA RCT Protocol 
 
6.7.3 
Spatial Span (WMS-III) ................................................................................................................................................. 31 
6.7.4 
Digit Symbol Coding test (WAIS-III) ........................................................................................................................... 32 
6.7.5 
Trail Making Test (TMT) .............................................................................................................................................. 32 
6.7.6 
Stroop Test (24 item Victoria Version) .......................................................................................................................... 32 
6.8 
Psychological assessment ................................................................................................................................. 33 
6.8.1 
Hospital Anxiety and Depression Scale (HADS) .......................................................................................................... 33 
6.9 
Social functioning ............................................................................................................................................. 34 
6.9.1 
Lubben Social Network Scale, Short Form (LSNS-R) .................................................................................................. 34 
6.9.2 
UCLA Loneliness Scale ................................................................................................................................................. 34 
6.10 
Nutrition ........................................................................................................................................................... 35 
6.10.1 
BMI ................................................................................................................................................................................ 35 
6.10.2 
Self-MNA ...................................................................................................................................................................... 35 
6.11 
Technology use ................................................................................................................................................. 36 
6.11.1 
Computer Literacy Scale (CLS) ..................................................................................................................................... 36 
6.11.2 
Evaluation of Usability Scale (SUS) .............................................................................................................................. 36 
6.11.3 
DART Questionnaire ..................................................................................................................................................... 36 
6.11.4 
User Experience Questionnaire (UEQ) .......................................................................................................................... 36 
7 
My-AHA Interventions .......................................................................................................................... 37 
7.1 
Physical Interventions ..................................................................................................................................... 38 
7.1.1 
Otago home-based exercise program (OED) ................................................................................................................. 38 
7.1.2 
Fitness and Mobility Exercise program (FAME) ........................................................................................................... 38 
7.1.3 
Endurance exercise programs ........................................................................................................................................ 39 
7.2 
Cognitive Interventions ................................................................................................................................... 40 
7.2.1 
Working memory training (N-back task) ....................................................................................................................... 40 
7.2.2 
Cognitive Bias Modification Therapy (CBMT) ............................................................................................................. 41 
7.3 
Psychosocial Interventions .............................................................................................................................. 42 
7.4 
Nutritional Interventions ................................................................................................................................. 43 
7.4.1 
Meal plan generation ..................................................................................................................................................... 43 
7.4.2 
Nutritional advice and education ................................................................................................................................... 43 
7.4.2.1 
Nutritional advice and education .......................................................................................................................... 43 
8 
My-AHA User Platform interface ........................................................................................................ 44 
9 
Safety and Screening Assessments ....................................................................................................... 48 
9.1 
Adverse Events ................................................................................................................................................. 48 
9.1.1 
Definition of Adverse Events (AE) ................................................................................................................................ 48 
9.1.2 
Definition of Serious Adverse Event (SAE) .................................................................................................................. 49 
9.1.3 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information ........................... 49 
9.1.4 
Assessment of Adverse Events ...................................................................................................................................... 50 
9.1.5 
Method of Detecting Adverse Events and Serious Adverse Events .............................................................................. 50 
9.1.6 
Follow-up of Adverse Events and Serious Adverse Events ........................................................................................... 50 
9.1.7 
Reporting of Serious Adverse Events ............................................................................................................................ 50 
9.1.8 
Regulatory Reporting Requirements for Serious Adverse Events ................................................................................. 51 

My-AHA RCT Protocol 
 
10 Data Management .................................................................................................................................. 52 
10.1 
Site specific ....................................................................................................................................................... 52 
10.2 
Project wide ...................................................................................................................................................... 52 
11 Responsibilities ....................................................................................................................................... 53 
11.1 
Investigator Responsibilities ........................................................................................................................... 53 
11.1.1 
Good Clinical Practice ................................................................................................................................................... 53 
11.1.2 
Institutional Review Board/Independent Ethics Committee Approval .......................................................................... 53 
11.1.3 
Informed Consent .......................................................................................................................................................... 53 
11.1.4 
Inspections ..................................................................................................................................................................... 53 
11.1.5 
Protocol Compliance ...................................................................................................................................................... 54 
11.1.6 
Study Report and Publications ....................................................................................................................................... 54 
11.2 
Joint Investigator/Consortium Responsibilities ............................................................................................ 54 
11.2.1 
Access to Information for Monitoring ........................................................................................................................... 54 
11.2.2 
Study Discontinuation .................................................................................................................................................... 54 
12 References ............................................................................................................................................... 55 
Appendix 1. 
PICF (Screening) ................................................................................................................ 57 
Appendix 2. 
PICF (RCT Intervention Group) ..................................................................................... 62 
Appendix 3. 
PICF (RCT Control Group) ............................................................................................. 70 
Appendix 4. 
Screening Assessment Checklist ....................................................................................... 81 
Appendix 5. 
Standard Demographic Questionnaire ............................................................................ 93 
Appendix 6. 
Brief demographic questionnaire ................................................................................... 101 
Appendix 7. 
WHOQoL-OLD................................................................................................................ 108 
Appendix 8. 
Lawton-Brody IADL Scale ............................................................................................. 115 
Appendix 9. 
CES-D 2 item questionnaire ............................................................................................ 117 
Appendix 10. 
Short Physical Performance Battery (SPPB) ................................................................ 119 
Appendix 11. 
IPAQ – Short Form ......................................................................................................... 127 
Appendix 12. 
Activities specific Balance Confidence (ABC) Scale ..................................................... 132 
Appendix 13. 
Physical Activity Enjoyment Scale (PACES) ................................................................ 134 
Appendix 14. 
Mini Mental State Examination (MMSE) ..................................................................... 137 
Appendix 15. 
Hopkins Verbal Learning Test (HVLT) ........................................................................ 141 
Appendix 16. 
WMS-III Spatial Span (SSP) test ................................................................................... 145 
Appendix 17. 
Trail Making Test (TMT) ............................................................................................... 147 
Appendix 18. 
24-item Victoria Version Stroop Test ............................................................................ 152 
Appendix 19. 
WAIS-III Digit Symbol Coding (DSC) test ................................................................... 157 
Appendix 20. 
Hospital Anxiety Depression Scale (HADS) .................................................................. 159 
Appendix 21. 
Lubben Social Network Scale – Revised (LSNS-R) ...................................................... 161 
Appendix 22. 
UCLA Loneliness Scale ................................................................................................... 165 
Appendix 23. 
Self-MNA scale ................................................................................................................. 167 

My-AHA RCT Protocol 
 
Appendix 24. 
Computer Literacy Scale (CLS) ..................................................................................... 170 
Appendix 25. 
Evaluation of Usability Scale (SUS) ............................................................................... 173 
Appendix 26. 
DART Questionnaire ....................................................................................................... 175 
Appendix 27. 
User Experience Questionnaire (UEQ) .......................................................................... 183 
 

My-AHA RCT Protocol 
 
Page 6 
List of Tables 
Table 1: My-AHA RCT inclusion criteria for participant screening ............................................................... 10 
Table 2:  Pre-frail inclusion criteria for participant screening ....................................................................... 11 
Table 3: My-AHA RCT exclusion criteria for participant screening ............................................................... 13 
Table 4:  Exclusion criteria for clinically significant deficits in Cognitive and Psychological function ........ 15 
Table 5: Devices required for participants in intervention group ................................................................... 18 
Table 6: Assessment battery for the My-AHA RCT assessment points ............................................................ 21 
Table 7: Intensity and duration of endurance training over 18 month RCT as determined by HRMax .......... 39 
 
 
 

My-AHA RCT Protocol 
 
Page 7 
List of Figures 
Figure 1: Protocol flowchart .............................................................................................................................. 8 
Figure 2: Schematic of Study Design ............................................................................................................... 20 
Figure 3: WMS-III Spatial Span board ............................................................................................................ 32 
 
 
 

My-AHA RCT Protocol 
 
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1 
Protocol Flowchart 
 
Figure 1: Protocol flowchart 
 
The My-AHA RCT protocol comprises 6 elements that will be described in detail below: 
1. Participant recruitment 
2. Participant screening 
3. Randomised allocation to control or intervention arm 
4. Periodic assessments 
5. Interventions 
6. My-AHA User Platform interface 
 
 

My-AHA RCT Protocol 
 
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2 
Recruitment 
 
2.1 
Type and Number of Participants 
Participants will be adults aged 60 years and older meeting study inclusion criteria for pre-frailty (Table 2) 
and not meeting study exclusion criteria for clinically significant cognitive and/or mood disturbance (Table 
4) or for concomitant diseases (see Section 3.2). 
A total of 50 participants will be recruited from the Sunshine Coast region. Participants will be community 
residing older adults, residing either in their own home/unit, retirement community, or residential aged care 
(non-secure). The majority are likely to be living in a semi-supported independent living setting receiving 
some aged care support services in own home/residence but otherwise fully independent. 
Participants who volunteer to participate in the RCT must be screened to ensure that each participant meet 
all inclusion criteria (Table 1) and do not meet any exclusion criteria (Table 3). 
 

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3 
Participant Screening 
 
3.1 
  Inclusion Criteria 
 
Table 1: My-AHA RCT inclusion criteria for participant screening 
 
 
 
 
 
INCLUSION CRITERIA 
1. Age: over 60 yrs  
2. Familiar with use of smartphones and/or tablet computers 
3. Have access to WiFi connection and existing internet data plan and provider 
4. Able to stand and walk unassisted 
5. Free of significant cognitive impairment (age-corrected MMSE ≥ 24) (Table 4) 
6. Free of clinically significant mood disturbance (HADS-Anxiety <15; HADS-depression < 15) (Table 4) 
7. Free of any acute or unstable medical conditions 
8. Meet criteria for pre-frail status (Table 2) 
9. Able to understand directions and participate in the protocol 
10. Able to sign informed consent 

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Table 2:  Pre-frail inclusion criteria for participant screening 
Clinical sign/symptom 
Measure 
Cutoff values 
PHYSICAL DOMAIN 
Pre-frail = 1 or 2 of the following criteria are met 
1. Shrinking, evidenced by weight 
loss (unintentional) 
 
≥ 4.5 kg unintentional in prior 12 months;  
or  
at follow-up assessment ≥ 5% of body weight 
in prior 12 months 
Self-reported weight loss (not due to dieting or fasting) in 
preceding 12 mo ≥ 4.5 kg 
Follow-up: K = (weight in previous year -  current measured 
weight)/(weight in previous year). If K ≥ 0.05, meets weight loss 
frailty criteria 
2. Weakness 
Grip strength in lowest 20% at baseline 
adjusted for gender and BMI 
        BMI 
Men BMI ≤ 24 
Men BMI 24.1 - 26 
Men BMI 26.1 - 28 
Men BMI > 28 
 
Women BMI ≤ 23 
Women BMI 23.1 - 26 
Women BMI 26.1 - 29 
Women BMI > 29 
    Grip strength cutoff (kg) 
≤ 29 
≤ 30 
≤ 30 
≤ 32 
 
≤ 17 
≤ 17.3 
≤ 18 
≤ 21 
3. Poor endurance and energy 
Self-report of exhaustion as indicated by 
responses to 2 questions on CES-D scale 
Using the CES–D Depression Scale, response of “2” (a moderate 
amount of the time, 3-4 days) or “3” (most of the time) to either of 
the following 2 items: 
 (a) I felt that everything I did was an effort;  
    and/or 
(b) I could not get going.  
4. Slowness 
Time to walk 15ft (4.57m) ≤ slowest 20% 
adjusted for gender and standing height 
    Gender/Height (cm) 
Men Height ≤ 173 cm 
Men Height > 173 cm 
Women Height ≤ 159 cm 
Women Height >159 cm 
Cutoff time to walk 4.00 m) 
≥ 6.13 sec 
≥ 5.25 sec 
≥ 6.13 sec 
≥ 5.25 sec 

My-AHA RCT Protocol 
 
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5. Low physical activity level 
Energy expenditure per week below 
established cutoff 
Short version of the IPAQ 
questionnaire assesses activity 
levels for walking, moderate-
intensity and vigorous-intensity 
activities for work, 
transportation, domestic chores, 
gardening and leisure-related 
activities. 
IPAQ Activity level measures 
as MET-min units). Convert 
IPAQ Met-min units to kcal 
using following formula 
adjusting for participants 
weight in kg: 
 
[kcal = MET-min x (weight 
kg/60)] 
 
Gender specific cutoff values: 
 Men: < 383 kcal 
 Women: <270 kcal 
 

My-AHA RCT Protocol 
 
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3.2 
  Exclusion Criteria 
Potential participants will be excluded if they meet one or more of the following exclusion criteria: 
 
Table 3: My-AHA RCT exclusion criteria for participant screening 
EXCLUSION CRITERIA 
Participant excluded if meets 1 or more of below: 
Mobility problems 
1. cannot stand and ambulate unassisted 
 
2. painful arthritis, spinal stenosis, amputation, or painful foot lesions 
that limits balance and mobility,  
Concurrent chronic disease 
independently contributing to 
frailty  
1. suffers from a significant neurodegenerative CNS disorder, e.g. 
a. Alzheimer’s disease 
b. Lewy body dementia 
c. Frontotemporal Lobar Degeneration, Fronto-Temporal 
Dementia 
d. Parkinson’s disease 
e. multiple sclerosis 
f. progressive supranuclear palsy 
g. amyotrophic lateral sclerosis 
h. hydrocephalus 
i. Huntington’s disease 
j. prion diseases 
2. affected by severe peripheral nervous system and/or 
neuromuscular disorders, e.g. 
a. CIDP 
b. myasthenia gravis 
c. multiple sclerosis 
d. polymyositis 
Concomitant injury or disease 
known to impact independently, 
cognitive psychological or 
physical function 
1. clinical evidence or history of stroke (within 2 yrs)  
2. clinical evidence or history of transient ischemic attack (within 6 
months) 
3. significant head injury with associated loss of consciousness, skull 
fracture or persisting cognitive impairment (2 years) 
4. epilepsy (a single prior seizure is considered acceptable)  
5. if meet DSM-5 criteria for:  
a. major depressive disorder (current) 
b. schizophrenia or other psychotic disorders (lifetime) 
c. bipolar disorder (within the past 5 years 
d. substance (including alcohol) related disorders (within the 
past 2 years) 
Presence of cognitive, sensory or 
perceptual deficits that interfere 
with assessment tasks 
1. have language deficits that impair testing 
2. have significant visual impairment 
3. have a significant hearing loss 

My-AHA RCT Protocol 
 
Page 14 
Presence of other conditions or 
diseases that will compromise 
participants’ ability to undertake 
interventions (especially physical) 
 
1. have clinically significant cardiovascular disease, i.e: 
a. hospitalization for acute coronary syndrome (acute 
myocardial infarction or unstable, angina)  
b. symptoms consistent with angina pectoris, within the 12 
months 
c. signs or symptoms of clinical heart failure within the 12 
months 
d. evidence of uncontrolled atrial fibrillation 
e. a cardiac pacemaker 
2. preexisting or current signs or symptoms of respiratory failure, e.g. 
a. chronic obstructive pulmonary disease 
b. bronchial asthma 
c. lung fibrosis 
d. other respiratory disease 
3. untreated hypertension  
4. metastatic cancer or immunosuppressive therapy 
 
5. concurrent acute or chronic clinically significant immunologic, 
hepatic (such as presence of encephalopathy or ascites), or 
endocrine disease (not adequately treated). 
Unacceptable Test/Laboratory 
Values 
1. Postural hypotension (fall in systolic blood pressure of greater 
than 30 mmHg or fall in diastolic blood pressure of greater 
than 20 mmHg on standing compared to sitting) at the time of 
screening.  Participants who present at the time of screening 
with postural hypotension yet have no known history of 
postural hypotension, nor underlying medical condition related 
to hypotension, may be rescreened 
 
 

My-AHA RCT Protocol 
 
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Table 4:  Exclusion criteria for clinically significant deficits in Cognitive and Psychological function 
Clinical sign/symptom 
Measure 
Cutoff values 
COGNITIVE DOMAIN 
Must NOT meet 1 or more of the EXCLUSION 
CRITERIA  
INCLUSION CRITERIA 
EXCLUSION CRITERIA 
1. Evidence of lowered general 
cognitive function 
Mini Mental State Examination test (MMSE) 
screens for deficits across several cognitive 
functions.  
Age-adjusted MMSE  
 24-30 (no cognitive 
impairment) 
Age-adjusted MMSE score 
 18-23 = MCI 
 0-17 = severe clinical 
deficit 
2. Evidence of lower than age-
appropriate learning and 
recall of verbal information 
Hopkins Verbal Learning Test (HVLT) is a brief test 
of verbal list learning and memory. Comprises 12 
words, organized into three semantic categories, and 
presented over three consecutive learning trials. 
HVLT-total recall score  
 Score ≥ 25 
HVLT-total recall score  
 Score ≤ 24 
PSYCHOLOGICAL DOMAIN 
 
Must NOT meet any EXCLUSION CRITERIA  
INCLUSION CRITERIA 
EXCLUSION CRITERIA 
1. Increased levels of anxiety 
and/or lowered mood 
experienced over the 
preceding week 
HADS – Hospital and Depression Scale, a 14-item 
scale to which participant indicates degree of 
agreement/frequency of experience in previous week 
on a 4 point scale. Seven of the items relate to 
anxiety and seven relate to depression. 
Scores are computed separately 
for the Anxiety scale (7 items – 
HADS-a) and the Depression 
scale (7 items – HADS-d): 
0-7 = normal mood 
8-10 = mild symptoms 
11-14 = moderate symptoms 
 Scores ≥ 15 - HADS-d  
and/or 
 Scores ≥ 15 - HADS-a 

My-AHA RCT Protocol 
 
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3.3 
  Screening Failures 
Screen Failures are defined as participants who sign a Screening Participant Informed Consent Form (PICF-
Screen) for My-AHA study but are not subsequently randomized and who do not enter the RCT.  
Participants who are Screen Failures may be rescreened once only after approval by the study Medical 
Supervisor (University of Torino, Italy). 
 
3.4 
  Withdrawal Criteria 
3.4.1 Reasons for Withdrawal 
 Any clinical AE, laboratory abnormality, or other medical condition or situation occurs such that 
continued participation in the study would not be in the best interest of the participant in the opinion 
of the investigator 
 Significant protocol violation 
 Participant requests to discontinue for any reason; it is important to determine whether the 
withdrawal of consent is primarily due to an AE, lack of efficacy, or other reason 
The above reasons do not automatically lead to withdrawal from the study in all cases.  The final decision 
will be based on consultation between the Principal Investigator and the study Medical Supervisor 
(University of Torino, Italy), with the ultimate decision by the principal investigator or participant.  
Participants may discontinue from treatment with study intervention but may agree to continue to be 
followed for additional safety evaluation. 
If a participant meets discontinuation criteria during treatment, the participant will undergo the Participant 
Withdrawal process (Section 3.4.2). 
 
3.4.2 Participant Withdrawal Procedures 
If a participant is prematurely discontinued from the intervention, the investigator must make every effort to 
perform the evaluations scheduled for the next assessment phase scheduled for that participant.   
 

My-AHA RCT Protocol 
 
Page 17 
4 
Participant randomization 
Participants will be randomized into 2 study arms, with 50% of participants allocated to each arm: 
 Study Arm 1: Control group (n = 25) 
 Study Arm 2: My-AHA intervention group (n = 25) 
Randomization will occur at each study site independently. 
Initial randomization of participants at each site will occur on a 1 (control) : 1 (intervention) ratio, with 
allocation of participants to each treatment arm being undertaken using on alternating allocation sequence 
based on order of entry into the study (i.e. participant 1 – study arm 1; participant 2 – study arm 2; 
participant 3 – study arm 1; participant 4 – study arm 2, and so on). 
Once recruitment and allocation to study arms of 20 participants has occurred at each site. The study site PI 
will submit to the RCT Study Coordinator basic demographic information on the 20 participants recruited 
and allocated to study arms. The demographic information required for each of the 20 participants is: 
 Gender 
 Age 
 Highest education level 
The RCT study coordinator will review the balance of participants across study arms for these demographic 
variables within each study site and advise the Principal Investigator of any adjustment to the allocation 
procedures for remaining participant assignment to treatment arms to ensure equivalence of study arms 
within each site. 

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5 
Devices 
Participants in the intervention group will require the following devices and access requirements: 
 
Table 5: Devices required for participants in intervention group 
1 
Android based smartphone and/or 
tablet computer 
Preferably participant’s own device. Can be supplied by site if 
participant does not own Android compliant device 
2 
Internet access – WiFi 
Participant’s own internet plan and WiFi modem in place of 
residence. 
3 
Mobile phone data 
Participant’s existing mobile phone plan and SIM card with 
appropriate level of data access 
4 
Medisana ViFit MX3 wristband 
Site to provide one ViFit activity tracking wristband per 
participant in the intervention group 
5 
Personal computer (optional) 
Participant’s own PC can be used an optional additional device for 
connection to My-AHA portal  
 

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6 
Assessment protocol 
6.1 
  Overall Design 
The design of the assessment phases is illustrated in Figure 2, with a detailed list of individual measures at 
each assessment phase described in Table 6. 

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Figure 2: Schematic of Study Design 
 

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Table 6: Assessment battery for the My-AHA RCT assessment points 
DOMAIN 
Test name 
Screening 
Baseline 
6mth 
12mth 
18mth 
Consent process 
Information sheets and consent forms  
(Appendix 1, Appendix 2, Appendix 3) 
Appendi
x 1 
 
 
 
 
Screening 
questionnaire 
Screening for inclusion and exclusion criteria; 
including pre-frail assessment 
 
 
 
 
 
Demographic 
Standard questionnaire  
 
Date of birth 
 
Gender 
 
Education (years completed) 
 
Residential status (live alone, with other 
etc.) 
 
Fear of falls 
 
Falls history 
 
Cognitive activities (mental activity) 
 
Medical history (diseases/diagnoses past 
and current, medication history) 
 
Continence 
 
 
 
 
 
 
Brief demographic update questionnaire (to track 
demographic variables than can change over 
time): 
 
Change in residential status since prior 
assessment 
 
Fear of falls 
 
Falls history since previous assessment 
 
Continence 
 
Cognitive activities (mental activity) 
since previous assessment 
 
Medical since previous assessment point 
(diagnoses existing and new, medication 
prescription current) 
 
 
 
 
 
RCT Adherence 
Cognitive games (in My-AHA platform) time 
spend in game, time scheduled 
 
 
 
 
 
 
iStoppFalls – time spent/time scheduled 
 
 
 
 
 
 
FAME – calendar with diary 
 
 
 
 
 
 
OTAGO – calendar with diary 
 
 
 
 
 
 
Endurance training (heart rate monitor, calendar 
with diary) 
 
 
 
 
 
 
VitalinQ – time spent/recipes used 
 
 
 
 
 
 
Technology – duration and frequency of app use 
 
 
 
 
 
Health 
WHO-QoL OLD 
 
 
 
 
 
 
Lawton-Brody iADL scale 
 
 
 
 
 
Physical 
Weight (kg) 
 
 
 
 
 
 
Height (cm) 
 
 
 
 
 
 
Grip strength 
 
 
 
 
 
 
CES-D (2 items assessing exhaustion) 
 
 
 
 
 
 
Time to walk 4m (SPPB) 
 
 
 
 
 
 
IPAQ-Short version 
 
 
 
 
 

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Page 22 
 
6-minute walk test 
 
 
 
 
 
 
Short Physical Performance Battery (SPPB) 
 
 
 
 
 
 
Dual-Task Performance (repeat of gait speed test 
of the SPPB) 
 
 
 
 
 
 
Timed up and Go test 
 
 
 
 
 
 
ABC (self-efficacy for physical function) 
 
 
 
 
 
 
PACES (Physical Activity Enjoyment Scale) 
 
 
 
 
 
Cognitive 
MMSE 
 
 
 
 
 
 
HVLT 
 
 
 
 
 
 
WMS-III Spatial Span (SSP) 
 
 
 
 
 
 
Trail Making Test (TMT-A & TMT-B) 
 
 
 
 
 
 
Stroop test (24 item Victoria Version) 
 
 
 
 
 
 
WAIS-III Digit Symbol substitution (DSS) 
 
 
 
 
 
Psychological 
HADS 
 
 
 
 
 
Social 
LSNS-R (Lubben Social Network Scale, Short 
form) 
 
 
 
 
 
 
UCLA Loneliness Scale 
 
 
 
 
 
Nutrition 
BMI (derived from height/weight data in 
Physical battery) 
 
 
 
 
 
 
Self-MNA 
 
 
 
 
 
Technology 
Evaluation of Usability Scale (SUS) 
 
 
 
 
 
 
DART questionnaire 
 
 
 
 
 
 
Computer Literacy Scale (CLS) 
 
 
 
 
 
 
User Experience Questionnaire (UEQ) 
 
 
 
 
 
 
 
Measures used to determine pre-frailty status of participants (see Table 2) 
Estimated maximum protocol duration: 
 
Screening assessment – 60 min (1hr) 
 
Baseline assessment – 155 min (2hr 35min) 
 
6 month assessment – 130 min (2hr 10 min) 
 
12 month assessment – 135 min (2hr 15 min) 
 
18 month assessment – 155 min (2hr 35min) 
 
 
 

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6.2 
Screening questionnaire 
Persons expressing an interest in participating in the My-AHA RCT will undergo formal screening to ensure 
that they meet inclusion criteria and do not meet any of the identified exclusion criteria (see Section 3 
Participant Screening, Table 1, Table 2, Table 3, Table 4). A standard questionnaire for participant screening 
will be used (Appendix 4) along with standard forms for the MMSE, HVLT, IPAQ, and HADS which will 
be administered to confirm each participant meets pre-frailty criteria for inclusion in the RCT. It is estimated 
that the screening process will take a maximum of 60 minutes to complete. 
   
6.3 
Adherence assessment 
Adherence to the intervention packages (see Section 6) are recorded automatically through the platform 
(Section 8). The system records all complete and incomplete sessions of intervention and can confirm 
whether a scheduled training session has been completed or not, which is then registered in the calendar. 
 
6.4 
Demographic measures  
6.4.1 Standard demographic questionnaire 
At baseline assessment, all participants will be required to complete the Standard Demographic 
Questionnaire (Appendix 5). 
This questionnaire collects information from each participant regarding: 
 Date of birth 
 Gender 
 Education (years completed) 
 Residential status (live alone, with other etc.) 
 Fear of falls 
 Falls history 
 Cognitive activities (mental activity) 
 Medical history (diseases/diagnoses past and current, medication history) 
 Continence/incontinence 
 
6.4.2 Brief demographic questionnaire 
At follow-up assessment time points (6, 12, 18 months) the Brief Demographic Questionnaire (Appendix 6) 
is to be completed by each participant. This questionnaire is designed to collect data on demographic 
variables that may change across the duration of the RCT, specifically information regarding changes in: 
 Change in residential status since last assessment 
 Current fear of falls 
 Falls history since last assessment 
 Cognitive activities (mental activity) engaged in since last assessment 
 Medical since last assessment point (diagnoses existing and new, medication prescription current) 
 Continence/incontinence 

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6.5 
Health assessment 
 
6.5.1 WHOQol-OLD 
The World Health Organisation Quality of Life – OLD extension (WHOQol-OLD) is a 24-item self-
administered scale, assessing quality of life in older adults (Appendix 7). 
Responses are recorded on Likert-scaled items assigned to six facets: “Sensory Abilities” (SAB), 
“Autonomy” (AUT), “Past, Present and Future Activities” (PPF), “Social Participation” (SOP), “Death and 
Dying” (DAD) and “Intimacy” (INT). Each of the facets has 4 items, thus for all facets the score of possible 
values can range from 4 to 20, provided all items of a facet have been completed (see Error! Reference 
ource not found.). The scores of these six facets or the values of the 24 single items of the WHOQOL-OLD 
module can be combined to produce a general (“overall”) score for quality of life in older adults, denoted as 
the WHOQOL-OLD module “total score”. As empirically supported by analyses of the measurement model 
via structural equation modelling (see below), quality of life is conceived as a higher-order factor, 
underlying the structure of the WHOQOL-OLD module. 
 
6.5.2 Instrumental Activities of Daily Living (iADL) 
The Lawton-Brody Instrumental Activities of Daily Living (iADL) Scale is an 8-item examiner administered 
scale, assessing the highest level of functional capacity of the participant across 8 areas of daily activity 
(Appendix 8): 
1. Ability to use a telephone 
2. Shopping 
3. Food preparation 
4. Housekeeping 
5. Laundry 
6. Mode of transportation 
7. Responsibility for own medications 
8. Ability to handle finances 
 
 

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6.6 
  Physical assessment 
 
6.6.1 Weight 
Participants weight (in kg) will be recorded at each assessment point on a standard set of calibrated digital 
scales. Each site will use the same digital scale for all participants. 
Additionally, participants will be screened to ascertain if they meet Fried criteria for weight loss 
(unintentional) of more than 4.5kg in the preceding 12 months. 
 
6.6.2 Height 
Participant’s height will be measured (in cm) using standardized stadiometer measurements. A stadiometer 
is constructed from a vertical ruler with a sliding horizontal headpiece which is adjusted to rest on top of the 
head. Each site will utilise the same stadiometer for all participant assessments at each visit. The stadiometer 
will be portable to enable assessment visits to occur at the participant’s place of residence. 
 
6.6.3 Grip Strength 
Dominant hand grip strength (kg) is to be assessed using a Jamar Hand Grip Dynanometer (Model 
5030J1). The participant is asked to sit upright in a chair without placing his/her forearms on armrests. With 
dynamometer handle held in their dominant hand., the participant is instructed “to squeeze your hand with 
all your power, give everything you have.” The examiner will provide verbal encouragement to the 
participant to squeeze harder during the assessment. The hand dynamometer is to be cleaned with alcohol 
disinfectant wipes after each participant.  
 
6.6.4 Exhaustion (CES-D) 
Two (2) items from the CES-D Depression scale will be completed by each participant. Participants respond 
on a 4-item Likert scale ranging from “rarely or none of the time (less than 1 day)” to “most or all of the 
time (5-7 days) for how often they have felt the following during the past week (Appendix 9): 
Item 7 
I felt that everything I did was an effort 
Item 20  
I could not get “going”. 
CES-D Response Key: 
Rarely or none of the 
time (less than 1 day) 
Some or a little of the 
time (1-2 days) 
Occasionally or a 
moderate amount of 
time (3-4 days) 
Most or all of the 
time (5-7 days) 
 
 
 
 
 

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6.6.5 IPAQ-short version 
The International Physical Activity Questionnaire (IPAQ) short form is a standardized and validated self-
administered questionnaire comprising 7 items that assess a person’s level of physical activity in the 
preceding 7 days across vigourous, moderate and gentle levels of activity (Appendix 11).  
IPAQ scores are converted to a standard energy consumption metric of MET-minutes/week. This metric is 
then converted to a kilocalorie (kcal) unit of energy expenditure adjusted for the participant’s weight using 
the following formula: 
kcal = (Total physical activity MET-min/week) x (weight kg/60) 
 
Gender specific cutoff values for PRE-FRAIL are based on kcal cutoffs: 
 Men: < 383 kcal 
 Women: <270 kcal 
 
 
6.6.6 6 minute walk test 
Description: The 6-Minute Walk test is a sub maximal measure of aerobic capacity. Participants may use 
an ambulation aid and oxygen if they do so normally.  The 6MWT is a useful measure of functional capacity 
suitable for frail older adults. The test has been widely used for preoperative and postoperative evaluation and 
for measuring the response to therapeutic interventions for pulmonary and cardiac disease.  
Equipment: pulse oximeter, Blood Pressure cuff, Borg RPE, dyspnea scale, stopwatch, tape measure, portable 
chair  
Absolute contraindications (test not to be administered):  
 unstable angina during the previous month  
 myocardial infarction during the previous month.  
Relative contraindications (test only administered with medical clearance):  
 Resting HR > 120  
 SBP > 180 mm Hg  
 DBP > 100 mm Hg  
 
Terminate exercise IMMEDIATELY if and of the following symptoms exhibited:  
Angina, light-headedness, confusion, ataxia, staggering unsteadiness, pallor, cyanosis, nausea, marked 
dyspnea, unusual fatigue, claudication or other significant pain, facial expressions signifying distress.  
Notify treating medical practitioner if test is terminated for any of the above reasons.  

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Instructions to the Participant:  
"The objective of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this 
hallway. Six minutes is a long time to walk, so maybe you will be exerting yourself. You will possibly get out 
of breath or become exhausted. You are permitted to slow down, to stop, and to rest as necessary. You may 
lean against the wall (or at chairs which are places throughout the course) while resting, but resume walking 
as soon as you are able.  
You will be walking back and forth around the cones. You should pivot briskly around the cones and continue 
back the other way without hesitation. Now I'm going to show you. Please watch the way I turn without 
hesitation. "We will avoid having a conversation so that you can save your wind for walking. You can begin 
when I say ‘go’. 
At the end of the 6 minutes: 
 Have participant sit down (portable chair) 
 Have patient rate their Borg Rate of Perceived Exertion (RPE), and dyspnea 
 Calculate and record the distance walked, as well as the RPE, heart rate and dyspnea values. 
 Ask: "What, if anything, kept you from walking farther?" 
 
Safety:  
Monitor vital signs before after the test. If there is an unexpected vital sign response, continue monitoring and 
documenting every 5 minutes until SBP and HR returns to within about 10-20 of pre-exercise values. Note 
heart rhythm, especially if it changes from a regular rhythm in pre-exercise to an irregular rhythm in post-
exercise. 
 
6.6.7 Timed up and go test 
Equipment: arm chair, tape measure, tape, stop watch. 
Begin the test with the participant sitting correctly (hips all of the way to the back of the seat) in a chair 
without arm rests. The chair should be stable and positioned such that it will not move when the participant 
moves from sit to stand. The participant is not allowed to use the arm rests during the sit – stand and stand – 
sit movements. 
Place a piece of tape or other marker on the floor 3 meters away from the chair so that it is easily seen by the 
participant. 
Instructions: “On the word GO you will stand up, walk to the line on the floor, turn around and walk back to 
the chair and sit down. Walk at your regular pace. (While giving the verbal instructions, the examiner 
performs the test once himself to ensure the participants understood the task) 
Start timing on the word “GO” and stop timing when the participant is seated again correctly in the chair 
with their back resting on the back of the chair. 

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The participant wears their regular footwear, may use any gait aid that they normally use during ambulation, 
but may not be assisted by another person. There is no time limit. They may stop and rest (but not sit down) 
if they need to. 
The participant should be given a practice trial that is not timed before testing. 
 
6.6.8 Short Physical Performance Battery (SPPB) 
Equipment required: 
 Chair with arms (46-18 cm high) 
 Stopwatch 
 Tape measure 
 tape to mark 4m 
SBBP subtests are administered in the following order (Appendix 10). 
 
6.6.8.1  Balance test 
Comprises 3 measures of balance. The examiner provides a verbal instruction with accompanying physical 
demonstration of the movement to be performed by the participant. If the participant is unable to perform the 
movement, then the next measure of balance is performed. 
The participant must be able to stand unassisted without the use of a cane or walker.  
(i) Side-by-Side Stand  
Participant is instructed to stand with feet together (side-by-side) for 10 seconds. The participant may 
use their arms, bend their knees, or move their body (but not their feet) to maintain balance. 
Examiner provides sufficient support of the participant’s arm to prevent any sudden loss of balance. 
If participant passes this test, proceed to test (ii). 
If participant unable to pass this test, proceed to test (b – Gait Speed Test) 
 
(ii) Semi-Tandem Stand  
Participant is instructed to stand with one foot in front and side of the other foot, such that the heel of 
one foot is touching the big toe of the other foot for 10 seconds. The participant may use their arms, 
bend their knees, or move their body (but not their feet) to maintain balance. Examiner provides 
sufficient support of the participant’s arm to prevent any sudden loss of balance. 
If participant passes this test, proceed to test (iii). 
If participant unable to pass this test, proceed to test (b – Gait Speed Test) 
 

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(iii) Tandem Stand  
Participant is instructed to stand with one foot in front and side of the other foot, such that the heel of 
one foot in in front of the other foot and the heel of one foot is touching the toes of the other foot (in 
a straight line) for 10 seconds. The participant may use their arms, bend their knees, or move their 
body (but not their feet) to maintain balance. Examiner provides sufficient support of the 
participant’s arm to prevent any sudden loss of balance. 
 
6.6.8.2 Gait Speed Test 
The examiner observes how the participant walks normally. Participant may use a cane or other walking aid 
if normally used.  
(i) First Gait Speed Test  
Participant walks a distance of 4m in a straight line – marked by a tape measure. Examiner 
demonstrates first, then follows behind the participant as they walk the course. Time to travel 4m is 
recorded. 
 
(ii) Second Gait Speed Test  
Participant repeats walking a distance of 4m in a straight line – marked by a tape measure. Examiner 
demonstrates first, then follows behind the participant as they walk the course. Time to travel 4m is 
recorded. 
 
(iii) Dual-task performance 
Participant repeats walking a distance of 4m in a straight line – marked by a tape measure. However, 
this time the participant is instructed to count backwards by 7 from 200 while walking (e.g. “200, 
193, 186 ….”). The participant counts aloud from when they start walking and stops counting once 
both feet have crossed the finish line. 
 
 
6.6.8.3 Chair Stand Test  
Examiner assesses the participant’s ability to stand from sitting on a chair and to repeatedly sit-stand-sit. 
(i) Single Chair Stand  
Participants is instructed to stand from sitting in a chair. They must keep their arms crossed/folded 
across their chest from seated to standing position.  
If unable to do so, they are instructed to use their arms to stand (do not proceed to next test). 
 

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(ii) Repeated Chair Stands  
Participants is instructed to stand from sitting in a chair without using their arms, for 5 repetitions as 
quickly as they can. They must keep their arms crossed/folded across their chest from seated to 
standing position and from standing to seated position.  
 
 
6.6.9 The Activities-specific Balance Confidence (ABC) scale 
The ABC is a self-rated 16 item questionnaire in which the participant indicates their level of confidence in 
doing a physical activity without losing their balance or becoming unsteady from choosing one of the 
percentage points on the scale form 0% to 100% (Appendix 12).  
Where the participant does not currently do the activity in question, they are asked try and imagine how 
confident they would be if they had to do the activity. If the participant normally uses a walking aid to do the 
activity or hold onto someone, they are asked to rate their confidence as though they were using these 
supports.  
 
6.6.10 Physical Activity Enjoyment Scale (PACES) 
The PACES is an 18 item questionnaire asking the participants to respond to questions relating to their 
enjoyment in undertaking physical activity at the moment (Appendix 13). 
Responses are provided on a 7 item Likert scale, with items 1, 4, 5, 7, 9, 10, 11, 13, 14, 16 and 17 being 
reverse scored (i.e. if participants select 1 score = 7; 2 = 6; 3 = 5; 4 = 4; 5 = 3; 6 = 2; 7 =1). 
Total score is the sum of scores of the 18 items, following reverse scoring of the 11 reversed items. Total 
score range is 18 – 126. 
 
 
 

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6.7 
Cognitive assessment 
 
6.7.1 Mini-Mental State Examination (MMSE) 
The MMSE is an 11-item brief screening assessment of basic cognitive functions [1] (Appendix 14). The 
MMSE is a clinical test, and will be administered by a trained and experienced researcher under the 
supervision of A/Prof Summers, APHRA registered Psychologist endorsed for practice as a Clinical 
Neuropsychologist. 
The 11 items on the MMSE assess: 
1. Orientation to time 
2. Orientation to place 
3. Registration of 3 objects 
4. Attention and calculation 
5. Recall of 3 objects 
6. Language and praxis 
Scores on the MMSE range from 0-30, and are corrected for level of education. 
Abnormal cutoff scores are: 
 < 24 – university/college education 
 < 23 – high school education (9-12 years formal education) 
 < 21 – junior high school education or less (fewer than 9 years of formal education) 
 
6.7.2 Hopkins Verbal Learning Test (HVLT) 
The Hopkins Verbal learning test (HVLT) [2] assesses verbal list-learning and memory through immediate 
recall, delayed recall and delayed recognition (Appendix 15). The test is commonly used to detect dementia 
and cognitive decline among respondents and allows insight into individuals’ memory function. This is a 
widely-used word learning test which consists of three immediate recall trials followed by a delayed recall 
20 minutes later. During this gap, other, non-memory-based cognitive tests may be performed. Parallel 
forms will be used across different assessment points to minimize potential practice effects. 
 
 
6.7.3 Spatial Span (WMS-III) 
A subtest of the Wechsler Memory Scale, 3rd edition (WMS-III) [3]. The test assesses a participant’s visual 
short term memory capacity. The examiner touches an increasingly long sequence of blocks (mounted on a 
board – see Figure 3) at 1 second intervals, which the participant then repeats. The trial ceases when the 
participant fails to correctly duplicate the sequence twice at the same length. The second trial involves the 
participant repeating the reverse sequence of the sequence demonstrated by the examiner. This backward 
span trial ceases when the participant fails to correctly duplicate the sequence twice at the same length 
(Appendix 16).  
Both trials commence with a 2 block sequence, and two sequences are presented at each sequence length 
before increasing sequentially to the next sequence length.  

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Figure 3: WMS-III Spatial Span board 
 
6.7.4 Digit Symbol Coding test (WAIS-III) 
This subtest of the Wechsler Adult Intelligence Scale – 3
rd 
edition (WAIS-III) [4] requires participants to correctly 
copy symbols that represent numbers and assesses visuomotor information processing speed and attention. 
Participants complete as many items as they can within a 120 second time limit (Appendix 19). 
 
6.7.5 Trail Making Test (TMT) 
A “join-the-dots” paper and pencil test consisting of two trials [5, 6]. The first trial requires participants to 
connect a series of numbers from 1 to 25 in numerical order as fast as possible. The second trial requires 
participants to connect a series of letters (A to L) concurrently with a series of numbers (1-13), such that the 
connections made are number-letter-number-letter, and so on, in alphabetical and numerical order 
(Appendix 17). Time taken to complete each trial and number of errors made are recorded 
 
6.7.6 Stroop Test (24 item Victoria Version) 
The 24-item Victoria version of the Stroop test requires subjects to name the ink colour of the print in three 
separate trials [6]. The first trial requires participants to name the ink colour of clusters of X’s. The second 
trial requires subjects to name the ink colour of simple nouns (e.g., car). The third trial requires subjects to 
name the ink colour of colour words (e.g., red), subjects must not name the word, but the colour of the ink in 
which the word is printed. The complexity on this trial is that the ink colour does not match the word, for 
example the word “red” might be printed in blue ink and the participant is required to say “blue” not “red”. 
Time taken to complete each trial and the number of errors made are recorded (Appendix 18). 
 
 

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6.8 
Psychological assessment 
 
6.8.1 Hospital Anxiety and Depression Scale (HADS) 
The HADS [7] is a self-report 14 item scale assessing symptoms of depression (7 items) and anxiety (7 items) 
experienced in the preceding 7 days. Responses are given on a 4-item scale, relating to frequency or 
intensity of symptoms experienced – each item has a score of 0-3 (Appendix 20). 
Anxiety scale and Depression scale are scored separately, each scale has a range of 0-21. 
For both Anxiety and Depression scales, the following cutoff values apply: 
Score 
Interpretation 
0 – 7 
Normal 
8 – 10 
Mild symptoms 
11 – 14 
Moderate symptoms 
15 – 21 
Severe symptoms 
 
 
 

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6.9 
Social functioning 
 
6.9.1 Lubben Social Network Scale, Short Form (LSNS-R) 
The LSNS-R scale is a 12-item questionnaire on which participants respond on a 6 item Likert scale [8]. Of 
the 12 questions, 6 relate to familial relationships and 6 relate to friendships. There are no reverse scored 
items (Appendix 21). 
LSNS-R Total score is the sum of scores across the 12 items, with subscores for family and friendships 
being the sum of scores for the 6 items in each. Scores range from 0-60 for LSNS-R Total Score, and from 
0-30 for each of the Family and Friendships subscores. 
 
6.9.2 UCLA Loneliness Scale 
The UCLA Loneliness scale is a 20-item questionnaire on which participants respond on a 4-point Likert 
scale regarding how frequently they experience feelings of social isolation and loneliness [9]. Of the 20 
items, 9 items are reverse scored (i.e. a score of 1 is counted as 4, 2 as 3, etc.). Total score is the sum of 
scores of the 20 items, following reverse scoring of the 9 reversed items. Total score range is 40-80 
(Appendix 22). 
 
 

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6.10 Nutrition 
 
6.10.1 BMI 
The Body Mass Index (BMI) for each participant will be calculated from weight and height data collected at 
each assessment phase using the following formula: 
 
BMI = [height(m) / weight (kg)] / [height(m)] 
 
6.10.2 Self-MNA 
The Self Mini Nutritional Assessment (Self-MNA) [10] is a brief questionnaire assessing the nutritional status 
of adults aged 65 years and older (Appendix 23). The Self-MNA is produced and licensed by Nestle 
Nutrition Institute, with permission to use this scale in the my-AHA project having been received. 
The Self-MNA comprises: 
1. 5 items relating to food intake, weight change, mobility, illness, dementia/depression 
2. Height and weight measures 
3. Circumference measurement of the left calf 
Preferably, the scale is investigator administered to ensure consistency of measurement of physical data. 
 
 
 

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6.11 Technology use 
 
6.11.1 Computer Literacy Scale (CLS) 
The CLS is a brief screening test to assess an individual’s level of familiarity with computer based 
interfaces. 
The CLS comprises 2 parts: 
 Part 1 – captures basis demographic information and items relating to experience with computers 
 Part 2 – assesses a participant’s familiarity with the meaning of various icons used by computer 
based systems as well as the meaning of basic menu options for computer programs. 
The CLS will be administered only at baseline assessment. 
 
6.11.2 Evaluation of Usability Scale (SUS) 
The SUS is a brief 10 item scale assessing a participants experience with the usability of the My-AHA 
platform. The participant responds to each of the 10 items on a 5 point scale from “strongly disagree” to 
“strongly agree” 
The SUS will be administered at a single assessment point (12 months) in the RCT protocol. 
 
6.11.3 DART Questionnaire 
The DART questionnaire surveys the participant’s responses to the use of application in the health care 
sector and their experiences in using the My-AHA application. 
 The survey comprises 3 parts: 
 Part 1- collects basis demographic information and responses to the value of the My-AHA 
application 
 Part 2 – comprises 19 items in which the participant rates the level of importance of different 
features of smartphone or tablet applications in the health care sectors 
 Part 3 – comprised the same 19 items repeated, but the participant is asked to respond with reference 
specifically to the My-AHA application. 
 
6.11.4 User Experience Questionnaire (UEQ) 
The UEQ is a 26 item scale assessing the participant’s description of the attributes of the My-AHA 
application. 
Participants are presented with a series of 26 paired (and opposing) attributes, to which they indicate their 
level of response on a 7 point scale. 
The UEQ will be administered at a single assessment point (18 months) at the completion of the RCT. 

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7 
My-AHA Interventions 
The intervention in this study is defined as the My-AHA platform. Participants randomized into the 
intervention arm will have access to the full My-AHA intervention platform (see also Section 8 My-AHA 
User Platform interface). Participants in the control group will not have access to the intervention package 
(no treatment control). All participants recruited into the study have no active disease state being treated. All 
participants meet study criteria for pre-frail status, a non-clinical disease state. 
The protocol in the intervention arm is designed to prevent deterioration from a non-clinical state (pre-frail) 
into the disease state (frail). 
The no-intervention control arm will not receive any element of the My-AHA intervention, a no-intervention 
non-disease control group. Participants in both study arms undergo formal assessment of clinical frailty 
status at 4 timepoints (baseline, 6 mo, 12 mo, 18mo). Development of clinical frailty is considered an 
adverse endpoint for the participant in this study. 
Where a control group participant displays evidence of clinical decline at 6 or 12mo assessment points 
(defined a meeting clinical criteria for frailty) they will be offered access to the My-AHA intervention suite. 
We cannot estimate or predict what proportion of the control participants may develop frailty during the 18 
month trial as there is no published data on incidence, age-dependent prevalence, or on average rate of 
decline into frailty from pre-frail states. 
 
Participants randomly allocated to the intervention group will be provided with access to tailored 
intervention packages. Intervention packages will target domains of pre-frailty (e.g. physical, social, 
cognitive, nutrition) identified at baseline assessment for each participant. The intervention packages will be 
revised following each assessment point to accommodate for changes in domain specific areas of pre-frailty. 
 
IMPORTANT NOTE: For participants in the control group access to interventions will not be provided – 
this is a no-treatment control group. The exception is when a control participant is found to meet clinical 
criteria for physical frailty at any of the post-baseline assessment points (6 month or 12 month). If 
progression to physical frailty is detected in a control group participant, that participant will be 
provided with immediate fully supported access to the physical intervention package to meet ethical 
obligations to the participant. 
 
 

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7.1 
Physical Interventions 
As the key physical markers of frailty are: weight loss, physical weakness, reduced endurance and energy, 
motor slowing, and reduced physical activity [11]; interventions have been selected to target these key 
physical indicators of frailty. With falls being the most likely consequence of increasing physical frailty [12], 
prevention of falls through balance training to enhance gait pattern and postural control is a key approach to 
be employed in the My-AHA project. In addition to fall prevention, endurance training will also be provided 
to increase physical activity levels, improve cardiovascular-fitness and therefore increase energy levels and 
endurance capacity. 
The multicomponent physical intervention deployed in the My-AHA project involve activities that combine 
strength, balance and endurance training over and extended duration (≥5 months), with high frequency 
repetition (performed three times per week) for 30–45 minutes per session. Such physical interventions have 
been found to result in superior outcomes compared to other exercise programs [13] and that exercise 
interventions combining strength, endurance and balance training display the greatest reduction in falls rate 
and improvement in gait, balance, and strength performance in physically frail older adults [14, 15]. 
For the strength and balance domains, the OTAGO (OEP) home-based exercise program [16], the Fitness and 
Mobility Exercise program FAME [17], and endurance training will be applied. Guidelines for endurance 
training will be provided based on the participants’ maximum heart rate (HRmax), with participants being 
able to choose the type of endurance activity from a range of options (e.g., walking, Nordic walking, 
bicycling, stationary bicycling, treadmill).  
 
7.1.1 Otago home-based exercise program (OED) 
The OEP [16] will be deployed as a home-based exercise programme used by older adults in their own homes 
without expert’s supervision. Prior to commencing the OEP program each participant will have a home visit 
from an exercise instructor who will prescribe an individually tailored set of exercises according to the 
participant’s clinical history and fitness level. The instructor will also provide each participant with detailed 
instructions regarding the correct implementation of each exercise. Participants will be provided with a 
booklet listing the exercises including short description and repetitions for each set as well as adjustable 
ankle cuff weights, which must be easy to take on and off. For participants, unable to exercise from a 
standing position, a chair-based exercise programme will be provided resistance-based training using ankle 
weights being replaced with resistance-bands.   
Participants will undertake the OEP program one session per week, as each participant will engage in one 
additional group-based exercise session that targets the same domains as in the OEP. In addition, the OEP 
advice of undertaking a walking activity will be replaced with a recommendation of undertaking some form 
of endurance training for one additional session per week. This modified OEP program, including group 
exercise and endurance training, will result in a total of 3 hours of physical training per week.   
 
7.1.2 Fitness and Mobility Exercise program (FAME) 
FAME is a standardised group-based exercise programme [17] which participants will complete one session 
per week under the supervision of a physical exercise instructor (appropriately qualified and trained fitness 
instructors, physical therapists or occupational therapists). Each group session will be undertaken with a 
ratio of no greater than 1 instructor per 5 participants.  
 

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7.1.3 Endurance exercise programs 
The endurance training exercise programs will be delivered in accordance with the guidelines of the 
American Heart Association and the American College of Sports Medicine for endurance training for older 
adults [18] and aims to reach the proposed recommendations of physical activity (150 min/week) by Month 9 
of the RCT. The walking part of the OEP will be replaced by an endurance training suggested to be 
undertaken for one session per week, with the endurance training activity to be selected by each participant 
to increase compliance (e.g. walking, Nordic walking, bicycling, treadmill or stationary bicycling). Intensity 
of the endurance training will start at a moderate level the first few months before gradually increasing to 
vigorous level activity adjusted for the participants’ estimated maximum heart rate (HRmax = 220bpm - 
age). The intensity rate (HRMax) to training duration is specified in Table 7. Participants are able to halt 
intensity increases if they perceive the level of intensity is too difficult. However, participants will be 
required to maintain a minimum of 65% of the HRmax for at least 150 Min per week.  
  
Table 7: Intensity and duration of endurance training over 18 month RCT as determined by HRMax 
Month 
Intensity 
(%HR max) Min/session 
1-2 
50% 
30 
3-4 
55% 
35 
5-8 
60% 
40 
9-12 
65% 
40 
13-16 
65% 
45 
17-18 
70% 
45 
  
 
 

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7.2 
Cognitive Interventions 
Cognitive interventions in the My-AHA project will comprise working memory training (N-back task), 
cognitive bias modification therapy (CBMT). As with physical interventions, the type of cognitive 
intervention offered to each participant will be individually tailored as determined by their individual areas 
of strength and weakness identified at each assessment point. 
 
7.2.1 Working memory training (N-back task) 
The main target group for n-back training is healthy elderly individuals. To achieve maximum adherence, 
self-efficacy, and engagement the n-back task will use graded difficulty whereby task difficulty is 
continuously adjusted to match participant level of performance.  
Two versions of the n-back task will be used: a letter-based and a visuospatial version. In the letter-based n-
back task, letters are capitalised at 20% of the monitor height and appear in black Arial font on a white 
background in the centre of the screen. For the visuospatial n-back task a 3 by 3 blue grid (11.5 cm x 11.5 
cm) is displayed on a white background size with a blue fixation cross is constantly visible in the centre slot. 
For the visuospatial n-back task, the stimulus is a blue square (3.5 cm x 3.5 cm) that appears in different 
positions inside the grid slots, except the centre position containing the fixation cross, hence 8 positions. For 
both letter-based and visuospatial n-back tasks, 8 combinations of presentation time (fixed 2000 ms; variable 
starting at 2000ms decreasing by 100 ms each successful block or increasing 100 ms each unsuccessful 
block; variable starting at 500 ms decreasing by 50 ms each successful block or increasing 50 ms each 
unsuccessful block) and inter-stimulus intervals (ITI; 0 ms or 2000 ms) will be used. Participants are 
instructed to respond by pressing a response key/button as to whether the letter currently on screen matches 
the letter presented n letters previously. The ratio of non-targets and targets is 2:1, presented in a random 
order. During a ‘lure’ trial the current stimulus matches the one n + 1 or n – 1 stimuli previously. Each block 
contains two lures (e.g., 2-back targets in a 3-back block), which constitutes 10% of all trials. Each block 
consists of 20 + n trials, such that a 3-back block would comprise 23 letters with 20 possible pairs. 
Participants begin their first trial with n = 2 (regardless of previous performances), while adjustments are 
continuously made, based on participants’ performance. Upon a successful block (at least 90% correct 
responses) n increases by 1, upon a non-successful block (below 75%), n decreases by 1. The level of n is 
maintained when participants give between 75% and 89% correct responses. A session comprises 15 blocks 
of n-back training (approximately 15 to 20 minutes). Participants will be provided with real-time feedback 
following each relevant trial, which is done using a stop-light paradigm. Two small circles (1.5 cm diameter, 
arranged green above red) are placed in the bottom left corner of the screen. All size measurements are 
relative to a 17-inch screen. The feedback is triggered directly following a response or in the case of a ‘miss’ 
during the ITI. In case of a match, the green circle lights up for 200 milliseconds. If participants’ response is 
incorrect (false positive, miss, or false negative) the red circle lights up for 200 milliseconds. At the end of 
the training session participants are provided with an overview of their performance, e.g.: correct hits, and 
misses, as well as average level of n. Au and colleagues [19] have reported a dose-dependent relationship 
between working memory training and positive outcomes. Reliable effects have been achieved using n-back 
training daily on weekdays for 20 days for 25 minutes (roughly 15 blocks). The training will be delivered 
via the My-AHA app directly (PC, Tablet or Mobile phone) but can also be installed on the participant’s 
home computer and operated with a keyboard or computer mouse.  
 
 

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7.2.2 Cognitive Bias Modification Therapy (CBMT) 
CBMT works by training anxious or depressed individuals to disengage from threat-related stimuli and 
redirecting their attention towards other ‘positive’ stimuli [20]. Such training has been found to lead to 
increased mood and lower stress reactivity [21, 22]. Essentially, during CBMT participants select ‘good’ or 
‘positive’ options over ‘bad’ or ‘negative’ ones. By consciously selecting the ‘positive’ option repeatedly, 
the negative bias becomes overridden and, over time, replaced by a novel, more adaptive habit. There are 
two common variants of CBMT, namely ‘attention bias modification’ (ABM) and ‘interpretative bias 
modification’ (CBM-I), which both have been reported to be effective in reducing anxiety and depression 
pathology [23]. ABM will be used in the My-AHA intervention package. In ABM participants learn to direct 
their attention towards relatively positive stimulus, which can be a word or a picture, and away from threat-
related stimuli.  
 
ABM is a modified computerized visual-probe procedure in which a pair of stimuli of different valences 
(e.g. a happy and a sad face, happy and neutral face, or neutral and sad face) are presented simultaneously 
then followed by presentation of a probe (one or two dots) behind one of the stimuli. Stimuli are presented 
for either 500 or 1000 ms before the probe is displayed. Randomization is set such that 500 and 1000 ms 
trials occur at the same frequency throughout a session. The presentation of a one-dot or two-dot probe is 
also randomized. Participants are instructed to press a button according to the number of dots presented. The 
appearance of the dots is manipulated, such that the dots always appear in place of the more positive 
stimulus. Participants learn implicitly to direct attention towards the happy stimuli and away from the 
negative ones, which constitutes a shift in attentional bias. A session of ABM comprises 96 trials and 
participants are recommended to complete two sessions daily for 28 sessions in total. 
 
 
 

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7.3 
Psychosocial Interventions 
Three social interventions will be implemented in the My-AHA project: group activity interventions; group 
support interventions, and a social media platform. 
Group activity interventions will increase participant engagement in social interaction by provision of 
targeted group based activities including: group physical activity classes, group cooking classes, and group 
excursion based activities (e.g., visiting a museum). The My-AHA platform will match participant’s 
preferences for type of activity and will create digital activity groups for participants with common 
preferences. The My-AHA platform then matches appropriate group activity proposals and presents the 
demand for specific group activities to secondary stakeholders as providers of group activities.  
Group support interventions will provide an opportunity for participants to find targeted help and support 
(e.g., bereavement support, disease support such as cancer support groups). My-AHA participants can set 
corresponding parameters in their profile to indicate their need for support. The My-AHA platform will 
match support groups to individual participants, based on the parameters and preferences set by the 
participant.  
The social media platform will address technology literacy of elderly people and allow digital interaction 
with all My-AHA participants. The social media platform will encompass the exchange and sharing of 
information as well as communication with other participants. It will provide a digital space for participants 
to interact with each other and share information, opinions, recommendations, etc.  
 
 

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7.4 
Nutritional Interventions 
Nutritional interventions will be implemented using a nutrition application (VitalinQ - 
https://www.vitalinq.nl/) for mobile devices. The interventions to be deployed include: individual meal plan 
generation, and tailored nutritional advice and education. 
 
7.4.1 Meal plan generation 
With meal plan generation, users will be able to plan meals ahead. In My-AHA application, meal plans and 
recommendations will be generated and presented to the user. The application will check in the database 
which recommendations and preferences fit the profile. The recommendations are official guidelines, which 
have been determined by official nutritional institutions in every participating country. The preferences 
(such as known allergies, lifestyle (e.g. vegetarian) and/or kitchen type) can be entered into the profile by the 
user. These recommendations and preferences will be compared to the recipes in the database. The 
recommendation engine should be able to generate meal plans that fit the needs of each user, based on their 
user profile.  The nutritional application will consider the anthropometric data, lifestyle, activity level, 
nutritional status of the user, and on user preferences in creating individually tailored meal plans. The 
application will generate plans for all different types of meals (breakfast, lunch, dinner and snacks), as well 
all meals for one day or all meals for one week.  
 
7.4.2 Nutritional advice and education 
7.4.2.1 Nutritional advice and education 
Participants will receive nutritional advice based on the food intake they log into their food diary [24].  Users 
will be educated on what they eat and get advice on how to improve their intake to meet their requirements. 
Educating the user on their food intake is important to ensure an improved eating pattern in the future. 
Therefore, the nutritional advice will be given in short passages of text, these feedback passages are derived 
from the nutritional database of VitalinQ and provide information as to whether the intake of a specific nutrient 
is high, low or as required and (if necessary) how to improve that intake and in most cases why.  
 

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8 
My-AHA User Platform interface 
The My-AHA platform is a web-based interface that has been designed for use via computer, tablet PC, 
and/or smart mobile telephone. 
The platform interface covers the following areas: 
1. Language selection (multi-language platform) 
2. User login (password secured) 
3. Menu interface enabling access to the User Dashboard, under which the user can select from 3 
different options 
a. Goals 
b. Interventions 
c. Results 
4. An a risk analysis page, which enables the user to identify their current level of risk for diseases such 
as dementia. The risk analysis page also enables the user to model the effect of changing different 
modifiable risk factors (e.g. increasing their level of exercise) and how these lifestyle changes result 
in measureable change to their risk of chronic diseases in the future. This provides the user with both 
a simple informational tool that also provides motivation to undertake a change to lifestyle which 
decreases risk for disease. 
The purpose built My-AHA Platform is illustrated in the Figures below. 

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9 
Safety and Screening Assessments 
 
9.1 
Adverse Events 
The Principal Investigator or site staff are responsible for detecting, documenting, and reporting events that 
meet the definition of an Adverse Event (AE) or Serious Adverse Event (SAE). 
 
9.1.1 Definition of Adverse Events (AE) 
An AE is any untoward medical occurrence associated with the use of an intervention in humans, whether or 
not considered intervention-related.  Therefore an AE can be ANY unfavorable and unintended sign, 
symptom, or disease temporally associated with the use of a product, without any judgment about causality. 
Events meeting the definition of an AE include: 
 
Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition. 
 
New conditions detected or diagnosed after product administration even though it may have been 
present prior to the start of the study. 
 
Signs, symptoms, or the clinical sequelae of a suspected intervention interaction. 
 
Clinically significant abnormal findings should be recorded as AEs.  A “clinically significant” finding is 
one that affects clinical management, including additional visits, monitoring or referrals, diagnostic 
tests, or alteration of treatment, or that is considered clinically significant by the investigator.  A 
clinically significant finding may be a change in a test that has previously been abnormal but now 
requires additional action. 
 
Events that do not meet the definition of an AE include: 
 
Anticipated day-to-day fluctuations or expected progression of pre-existing disease(s) or condition(s) 
present or detected at the start of the study unless judged by investigator to be more severe than 
expected for the participant’s underlying condition. 
 
Abnormal clinical measurements that are not labelled clinically significant (see definition above). 
 
Situations where an untoward medical occurrence did not occur (social and/or convenience admission to 
a hospital). 
 
Overuse of the intervention in the absence of other AEs will not be reported as an AE in its own right. 
 
Adverse events are recorded from the time that informed consent is signed.   
 

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9.1.2 Definition of Serious Adverse Event (SAE) 
An SAE is considered serious if, in the view of either investigator or medical supervisor, it results in any of 
the following outcomes: 
 Death, 
 A life-threatening AE (an AE is considered “life-threatening” if, in the view of either the investigator 
or medical supervisor, its occurrence places the participant at immediate risk of death.  It does not 
include an AE that, had it occurred in a more severe form, might have caused death.  The 
determination of whether an AE is life-threatening can be based on the opinion of either the 
investigator or medical supervisor.  Thus, if either believes that it meets the definition of life-
threatening, it must be considered life-threatening for reporting purposes). 
 Inpatient hospitalization, 
 A persistent or significant incapacity or substantial disruption of the ability to conduct normal life 
functions, or 
 Important medical events that may not result in death, be life-threatening-, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the outcomes listed in 
this definition.  Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or a fall requiring hospitalisation. 
This definition of an SAE permits either the medical supervisor or the investigator to decide if an event is 
serious.  Because SAEs are critically important for the identification of significant safety problems.  For 
example, the investigator’s perspective may be informed by having actually observed the event, and the 
medical supervisor is likely to have broader knowledge of the intervention and its effects to inform its 
evaluation of the significance of the event.  If either the medical supervisor or investigator believes that the 
event is serious, the event must be considered serious and evaluated by the sponsor for possible expedited 
reporting. 
 
9.1.3 Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information 
Collection of AEs and SAEs will begin at the time a participant signs informed consent and continues until 
the follow-up contact. 
All SAEs will be recorded and reported to Project Management Board (PMB) within 24 hours of the 
investigator becoming aware of the SAE. 
Investigators are not obligated to actively seek AEs or SAEs in former study participants.  However, if the 
investigator learns of any SAE, including a death, at any time after a participant has been discharged from 
the study, and he/she considers the event reasonably related to the intervention or study participation, the 
investigator must promptly notify the PMB. 
 

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9.1.4 Assessment of Adverse Events 
The severity of each AE will be assessed by the investigator, or designee approved and documented for this 
study, as mild, moderate, or severe based on the below definitions: 
 Mild: Event that is usually transient and may require only minimal treatment or therapeutic 
intervention.  The event does not generally interfere with usual activities of daily living 
 Moderate: Event that is usually alleviated with additional specific therapeutic intervention.  The 
event interferes with usual activities of daily living, causing discomfort, but poses no significant or 
permanent risk of harm to the participant. 
 Severe: Event that interrupts usual activities of daily living or significantly affects clinical status, or 
may require intensive therapeutic intervention. 
Note that severity is not the same as “seriousness”.  Outcome will be assessed using the following 
categories: recovered/resolved, not recovered/not resolved, recovered/resolved with sequelae, fatal, or 
unknown. 
 
9.1.5 Method of Detecting Adverse Events and Serious Adverse Events 
Care will be taken not to introduce bias when detecting AEs and/or SAEs.  Open-ended and non-leading 
verbal questioning is the preferred method to inquire about AE occurrence.  Appropriate questions include: 
 
“How are you feeling?” 
 
“Have you had any (other) medical problems since your last visit/contact?” 
 
“Have you taken any new medicines, other than those provided in this study, since your last 
visit/contact?” 
 
9.1.6 Follow-up of Adverse Events and Serious Adverse Events 
After the initial AE/SAE report, the investigator is required to proactively follow each participant at 
subsequent visits/contacts.  All AEs and SAEs will be followed until resolution, until the condition 
stabilizes, until the event is otherwise explained, or until the participant is lost to follow-up.  
 
9.1.7 Reporting of Serious Adverse Events 
All new SAEs must be reported in English to the Project Management Board within 24 hours of the 
investigators first knowledge of the event regardless of relationship to the study procedures.  All deaths must 
be reported within 24 hours of the investigator’s first knowledge of the event.  It is recognized that complete 
information may not be available at the time of the initial SAE report.  Additional information should be 
supplied on subsequent Serious Adverse Event Forms as it becomes available.   
For the initial SAE notification report, the investigator must provide, at minimum, basic information such as 
the protocol number, participant’s initials and date of birth, participant identification number, period of 
investigational product intake, event term, nature of the event, the seriousness criteria, and the investigator’s 
attribution regarding relatedness to investigational product.  In addition, the initial SAE report should 

My-AHA RCT Protocol 
 
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include all pertinent known information about the SAE and the affected participant.  In addition, the 
investigator should provide a narrative to describe the course of events including any treatments or relevant 
procedures.  Follow-up information, which may include copies of relevant participant records and other 
documents not available at the initial SAE report must be sent to the Project Management Board as soon as 
available.  Follow-up SAE reports may describe the evolution of the reported event and any new assessment 
of outcome and/or relationship to investigational product.  Full supporting documentation should be solicited 
by the investigative site even if the SAE occurred at another institution.  Such documentation may include 
copies of relevant medical/hospital records, pathology, or autopsy reports where available.  
 
9.1.8 Regulatory Reporting Requirements for Serious Adverse Events 
Prompt notification by the investigator to the medical supervisor of all SAEs and non-serious AEs occurring 
during a clinical trial is essential so that legal obligations and ethical responsibilities towards the safety of 
participants are met. 
An investigator who receives an investigator safety report describing an SAE(s) or other specific safety 
information (e.g., summary or listing of SAEs) will file it with the Investigator Brochure and will notify the 
Institutional Review Board/Institutional Ethics Committee (IRD/IEC), if appropriate according to local 
requirements. 
 

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10 Data Management 
10.1 Site specific 
Each site PI is responsible for the management and storage of data collected at the site. All data will be 
collected using standard de-identification procedures: 
1. Each participant will be allocated a unique identifier code 
2. A master key matching the identifier code to the identity of the participant will be retained as a 
secured, encrypted data file; separate in location to all data collected in this study. The master key 
file can only be access by the site PI and authorized research personnel at the site. 
3. All data collected from each participant will be identified only by the unique identifier code. 
4. Data storage and security is the responsibility of the site PI 
5. The site PI will transfer de-identified data the study coordinator using secure, encrypted HTTPS 
transfer protocol. Only de-identified data can be transferred to the study coordinator for combining 
with data from all study sites to enable data analysis. 
6.  
10.2 Project wide 
The study coordinator is responsible for the management and storage of multi-site de-identified data 
collected across the multiple sites involved in the RCT. 
1. Data from each participant will only be identified by a unique identifier code indicating the study site 
from which the data was collected 
2. No persons will be able to identify the identity of the individual from the identifier code used. Only 
the site PI will retain the master key for participant identities specific to their site. 
3. Data storage and security of the combined multi-site data is the responsibility of the study 
coordinator 
 
 
 

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11 Responsibilities 
11.1 Investigator Responsibilities 
11.1.1 Good Clinical Practice 
The investigator will ensure that this study is conducted in accordance with the principles of the National 
Health and Medical Research Council (NHMRC) of Australia, as well as the “Declaration of Helsinki” (as 
amended in Edinburgh, Tokyo, Venice, Hong Kong, and South Africa), International Conference on 
Harmonisation (ICH) guidelines, or with the laws and regulations of the country in which the research is 
conducted, whichever affords the greater protection to the study participant.  The investigator will ensure 
that the basic principles of “Good Clinical Practice,” as outlined in 21 Code of Federal Regulations (CFR) 
312, subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, part 50, 1998, and 21 CFR, part 
56, 1998, are adhered to.  These standards are consistent with the requirements of the European Community 
Directive 2001/20/EC, which shall be adhered to fulfil the contractual requirements of this European 
Commission funded research project. 
 
11.1.2 Institutional Review Board/Independent Ethics Committee Approval 
This protocol and any accompanying material to be provided to the participant and caregiver (such as 
advertisements, participant information sheets, or descriptions of the study used to obtain informed consent) 
will be submitted by the investigator to an IRB or IEC.  Approval from the IRB or IEC must be obtained 
before starting the study and should be documented in a letter to the investigator specifying the protocol 
number, protocol version, protocol date, documents reviewed, and date on which the committee met and 
granted the approval. 
Any modifications made to the protocol or other documents described in the above paragraph after receipt of 
IRB or IEC approval must also be submitted to the IRB or IEC for approval before implementation. 
 
11.1.3 Informed Consent 
The investigator is responsible for obtaining written informed consent from each individual participating in 
this study after adequate explanation of the aims, methods, objectives, and potential hazards of the study and 
before undertaking any study-related procedures.  The investigator must utilize an IRB- or IEC-approved 
consent form for documenting written informed consent.  Each informed consent will be appropriately 
signed and dated by the participant or the participant’s legally authorized representative and the person 
obtaining consent.  Consent from both the caregiver representative and participant will be obtained. 
 
11.1.4 Inspections 
The investigator should understand that source documents for this trial should be made available to IRBs or 
IECs, or to regulatory authority or health authority inspectors. 
 

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11.1.5 Protocol Compliance 
The investigator is responsible for ensuring the study is conducted in accordance with the procedures and 
evaluations described in this protocol. 
 
11.1.6 Study Report and Publications 
A clinical study report will be prepared and provided to the regulatory agencies.   
 
 
 
11.2 Joint Investigator/Consortium Responsibilities 
11.2.1 Access to Information for Monitoring 
In accordance with ICH Good Clinical Practice (ICH GCP) guidelines, the Study Coordinator must have 
direct access to the investigator’s source documentation in order to verify the data recorded for consistency.  
The Study Monitor is responsible for routine review of the data collected at regular intervals throughout the 
study to verify adherence to the protocol and the completeness, consistency, and accuracy of the data being 
entered on them.  The monitor should have access to any de-identified participant records needed to verify 
adherence.  The site PI agrees to cooperate with the study coordinator to ensure that any problems detected 
in the course of these monitoring visits are resolved. 
 
11.2.2 Study Discontinuation 
The Consortium reserves the right to terminate the study at any time.  Should this be necessary, both parties 
will arrange discontinuation procedures and notify the appropriate regulatory authority(ies), IRBs, and IECs.   

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12 References 
1.  Folstein, M.F., Folstein S.E., McHugh P.R., "Mini-mental state". A practical method for grading the 
cognitive state of patients for the clinician. Journal of psychiatric research, 1975. 12: 189-98. 
2.  Brandt, J., The Hopkins Verbal Learning Test: development of a new memory test with six equivalent 
forms. Clinical Neuropsychologist, 1991. 5: 125-42. 
3.  Wechsler, D., Wechsler memory scale - third edition (WMS-III): Administration and scoring manual. 
1997, San Antonio, TX: The Psychological Corporation. 
4.  Wechsler, D., Wechsler adult intelligence scale - third edition (WAIS-III): Administration and scoring 
manual. 1997: The Psychological Corporation. 
5.  Lezak, M.D., Howieson D.B., Bigler E.D., et al., Neuropsychological assessment. 5th ed. 2012, Oxford: 
Oxford University Press. 
6.  Strauss, E., Sherman E.M.S., Spreen O., A compendium of neuropsychological tests: Administrations, 
norms, and commentary. 3rd ed. 2006, New York: Oxford University Press. 
7.  Snaith, R.P., Zigmond A.S., The Hospital Anxiety and Depression Scale (HADS): Manual. 1994, 
London, UK: GL Assessment Ltd. 
8.  Lubben, J.E., Assessing social networks among elderly populations. Family & Community Health, 1988. 
11: 42-52. 
9.  Russell, D., Peplau L.A., Cutrona C.E., The revised UCLA Loneliness Scale: Concurrent and 
discriminant validity evidence. Journal of Personality and Social Psychology, 1980. 39: 472-80. 
10.  Nestlé Nutrition Institute, Self-MNA: Mini nutritional assessment - for adults 65 years of age and older. 
2012, Vevey, Switzerland: Société des Produits Nestlé S.A. 
11.  Fried, L.P., Tangen C.M., Walston J., et al., Frailty in older adults: evidence for a phenotype. The 
Journals of Gerontology Series A: Biological Sciences and Medical Sciences, 2001. 56: M146-56. 
12.  de Vries, O.J., Peeters G.M., Lips P., et al., Does frailty predict increased risk of falls and fractures? A 
prospective population-based study. Osteoporos International, 2013. 24: 2397-403. 
13.  Theou, O., Stathokostas L., Roland K.P., et al., The effectiveness of exercise interventions for the 
management of frailty: A systematic review. Journal of Aging Research, 2011. 2011: 19. 
14.  Cadore, E.L., Pinto R.S., Bottaro M., et al., Strength and endurance training prescription in healthy and 
frail elderly. Aging and Disease, 2014. 5: 183-95. 
15.  Cadore, E.L., Rodríguez-Mañas L., Sinclair A., et al., Effects of different exercise interventions on risk 
of falls, gait ability, and balance in physically frail older adults: A systematic review. Rejuvenation 
research, 2013. 16: 105-14. 
16.  Gardner, M.M., Buchner D.M., Robertson M.C., et al., Practical implementation of an exercise‐based 
falls prevention programme. Age and Ageing, 2001. 30: 77-83. 

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17.  Eng, J.J., Fitness and mobility exercise program for stroke. Topics in Geriatric Rehabilitation, 2010. 26: 
310-23. 
18.  Mazzeo, R.S., Cavanagh P., Evans W.J., et al., ACSM Position Stand: Exercise and physical activity for 
older adults. Medicine & Science in Sports & Exercise, 1998. 30: 992-1008. 
19.  Au, J., Sheehan E., Tsai N., et al., Improving fluid intelligence with training on working memory: a 
meta-analysis. Psychonomic Bulletin & Review, 2015. 22: 366-77. 
20.  Wadlinger, H.A., Isaacowitz D.M., Looking happy: The experimental manipulation of a positive visual 
attention bias. Emotion (Washington, D.C.), 2008. 8: 121-6. 
21.  MacLeod, C., Rutherford E., Campbell L., et al., Selective attention and emotional vulnerability: 
assessing the causal basis of their association through the experimental manipulation of attentional 
bias. Journal of abnormal psychology, 2002. 111: 107-23. 
22.  Mathews, A., MacLeod C., Induced processing biases have causal effects on anxiety. Cognition and 
Emotion, 2002. 16: 331-54. 
23.  MacLeod, C., Mathews A., Cognitive bias modification approaches to anxiety. Annual review of 
clinical psychology, 2012. 8: 189-217. 
24.  Mensink , R.P., Katan  M.B., Effect of a diet enriched with monounsaturated or polyunsaturated fatty 
acids on levels of low-density and high-density lipoprotein cholesterol in healthy women and men. 
New England Journal of Medicine, 1989. 321: 436-41. 

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Appendix 1. PICF (Screening) 
 
 

 
 
 
Page 1 of 6 
PARTICIPANT INFORMATION SHEET – Screening 
 
Screening to participate in the My Active and Healthy Ageing (My-AHA) – Randomised 
Control Trial 
 
This information sheet is for you to keep. The information sheet is long, but it is important that you read it 
carefully before you agree to participate in this study. 
 
You have expressed an interest in participating in randomised control trial study aiming to identify 
individuals at risk for frailty and to assess different interventions to reduce your risk for frailty. Before we 
can enrol you in the 18 month long randomised control trial, we will need to screen you to ensure that you 
are a suitable candidate for the study and that you meet the selection criteria for participating in the study.  
 
It is important to note, that if you meet the entry requirements for the study, you will then be formally 
invited to participate in the 18 month randomised control trial. If you accept this invitation you will then be 
randomly allocated to one of two groups: 
1. A control group, in which you will undergo routine assessments at 6 month intervals but will not 
undertake any of the interventions being used in this study 
2. An intervention group, in which you will undergo routine assessments at 6 month intervals and will 
undertake tailored interventions between each assessment point. 
Participants invited into the study will be allocated randomly and evenly across both groups. This means you 
have a 1 in 2 chance (50%) of being allocated to either the control or the intervention group. 
 
If you are happy with these conditions, please continue reading this information sheet. Once you have read 
this information sheet, if you wish to participate in this study please complete the attached consent form. If 
you have any questions, or would like additional information about the trial, please speak with Associate 
Professor Mathew Summers either in person, or by telephone on 5456 3758. A/Prof Summers is the 
Principal Investigator and trial site coordinator for the Australian trial. 
 
 

 
 
 
Page 2 of 6 
The My-AHA randomised control trial is a multi-site, multi-national study. The Australian trial site is being 
conducted by: 
 Associate Professor Mathew Summers (Principal Investigator and Trial Site Coordinator - Australia), 
Associate Professor of Neuropsychology & Mental Health, Sunshine Coast Mind and Neuroscience – 
Thompson Institute, University of the Sunshine Coast  
There are other trial sites involved in this study from: 
 Italy 
 Austria 
 Spain 
 Germany 
 United Kingdom 
 Belgium 
 Sweden 
The Australian trial site is being coordinated from the Sunshine Coast Mind and Neuroscience - Thompson 
Institute; a research institute of the University of the Sunshine Coast which is located at 12 Innovation 
Parkway, Birtinya.  
 
1. ‘What is the purpose of this study?’ 
Older adults with physical frailty are at increased risk of falls and other secondary complications. Frail older 
adults experience a loss of independence and increasing need for residential care. There is evidence to 
suggest that it is possible to reverse this risk by targeting a person’s risk factors for developing frailty before 
frailty appears. The aim of this study is to test a new platform that we have developed to monitor an 
individual’s risk for frailty in physical function (e.g. balance), cognition (e.g. memory), mood (e.g. 
depression), social activity (e.g. isolation), and nutrition (e.g. healthy eating). We will then develop a risk 
profile for each individual that recognises their specific areas of risk across these domains. This will results 
in our platform recommending specific activities (e.g. physical exercises, social activities in groups, diet 
changes) that will target the specific areas of risk for that individual participant.  We believe that this 
approach will lead to a significant reduction in an older adult’s risk for frailty, thereby promoting ongoing 
independence for the older adult in the community. 
 
2. ‘Why have I been invited to participate in this study?’ 
You have been invited to this screening because you have expressed an interest and are: 
(a) Aged over 60-75 years;   
(b) Able to stand and walk unassisted 
(c) Do not suffer from a significant cognitive impairment (e.g. dementia) 
(d) Do not suffer from a psychological or psychiatric condition (e.g Depression) 
(e) Do not current have an acute (i.e. current or recent) or unstable (i.e. not well-controlled) medical 
condition 
(f) Able to understand directions and participate in this study 
(g) Able to give fully informed consent  
 
3. ‘What does participation in this screening study involve?’ 
To assess your eligibility to take part in this study, we will first ask you a series of questions about your: 
 Mobility 
 Medical history 
 Psychological and psychiatric history 
 Medication history 
In addition, we will measure your blood pressure and screen your basic cognitive functions. 
 

 
 
 
Page 3 of 6 
If you meet eligibility requirements and are willing to participate in this study, we will contact you to 
formally invite you to participate in the randomised control trial study. Should you accept you will be 
randomly allocated to either the control group or the intervention group for an 18 month long study trial. 
 
When you are invited to participate in the study trial we will again fully explain all aspects of the study trial 
and ask you to consent to participate in that trial. 
 
4. ‘Is information about me confidential and can I withdraw from the study?’ 
It is important that you understand that your involvement in this screening study is voluntary. While we 
would be pleased to have you participate, we respect your right to decline. There are no consequences to you 
if you decide not to participate. If you decide to discontinue participation at any time, you may do so without 
providing an explanation. All information will be treated in a confidential manner, and your name will not 
be used in any publication arising out of the research. All of the research will be kept as secure computer 
files by A/Prof Summers, and only A/Prof Summers will have full access to re-identifiable information.  
 
5. ‘Are there any possible benefits from participation in this study?’ 
The information collected from you at screening will determine your suitability to participate in the 
randomised control trial to assess the capacity of interventions to reduce a person’s risk for frailty. 
 
6. ‘Are there any possible risks from participation in this study?’ 
There are no significant harms or risk associated with participating in this study. You will be asked to 
disclose information regarding your personal life (e.g. education, family, occupation) and medical history. 
Some people may feel discomfort in disclosing personally sensitive information. We require this information 
to ensure that you are eligible to participate in the randomised control trial and that participating in the 
randomised control trial will not result in harm to yourself due to another condition. It is therefore important 
that you disclose all information that we request so that we can ensure you are safe to participate. 
All information we collect from you is treated as strictly confidential and will be de-identified to protect 
your privacy. No individual information will be presented in any papers coming from this project, only 
summary data from the entire group will be reported, ensuring that your personal information cannot be 
identified. 
 
7. ‘How is this research funded?’ 
The Australian study site at the Sunshine Coast Mind and Neuroscience – Thompson Institute is funded by a 
National Health and Medical Research Council (NHMRC) European Union Project Grant (1115818) 
awarded to A/Prof Mathew Summers as Chief Investigator. 
The European trial sites are funded by a European Commission HORIZON2020 Consortium GHrant, on 
which A/Prof Summers is a Principal Investigator. 
 
8. ‘What if I have questions about this research?’ 
If you would like to discuss any aspect of this research please feel free to contact A/Prof Mathew Summers 
on 5456 3758, or email msummers@usc.edu.au. A/Prof Summers would be happy to discuss any aspect of 
the research with you. You are welcome to contact A/Prof Summers at any time to discuss any issue relating 
to the research study.  
 
 
 

 
 
 
Page 4 of 6 
This study has been approved by the Human Research Ethics Committee (Ethics approval number: 
********).  If you have concerns or complaints about the conduct of this study you can raise them with the 
Principal Investigator (A/Prof Mathew Summers). If you prefer an independent person, contact the 
Chairperson of the Human Research Ethics Committee at the University of the Sunshine Coast: (c/- the 
Research Ethics Officer, Office of Research, University of the Sunshine Coast, Maroochydore DC, 4558; 
telephone (07) 5459 4574; email humanethics@usc.edu.au. You will need to quote HREC project HREC 
**** My Active and Healthy Ageing (My-AHA) randomised control trial study. 
 
On behalf of A/Prof Mathew Summers, the European Consortium partners, and the University of the 
Sunshine Coast, we thank you for taking the time to consider participating in this study.  
 
If you wish to participate in this screening study, please sign the attached consent form. This information 
sheet is for you to keep. 
 

 
 
 
Page 5 of 6 
CONSENT FORM 
 
TITLE OF PROJECT: 
The relationship between vascular processes and neurocognitive function in non-stroke 
cardiovascular disease: A prospective longitudinal investigation  
 
1. I have read and understood the ‘Information Sheet’ for this project. 
2. The nature and possible effects of the study have been explained to me. 
3. I understand what my participation in this study involves as outlined in the ‘Participant Information 
Sheet’ 
4. I understand that I will be asked to provide information regarding my demographic information, 
mobility, medical history, psychological and psychiatric history, and medication history.  
5. I understand that I will have my blood pressure assessed.  
6. I understand that I will have my cognitive functions screened. 
7. I understand that information that identifies me will be removed and all information will be retained as 
confidential and will only be used for the purposes of the research project. 
8. I understand that the results of my participation in this screening assessment will be used to determine if 
I am eligible to participate in the randomised control trial. I agree to being invited to participate in the 
randomised control trial if I am found to meet the eligibility criteria. 
9. Any questions that I have asked have been answered to my satisfaction.  
10. I agree that the research data gathered from me for the study may be published provided that I cannot be 
identified as a participant. 
11. I agree that my de-identified data from this research can be used in future research projects. 
12. I agree that my data (de-identified) can be shared with other researchers. 
13. I agree to participate in this investigation and that I may withdraw at any time without any effect or 
explanation, and if I so wish, may request that any data I have supplied to date be withdrawn from the 
research.  
 
Name of Participant:  
 
 
Signature:                                                                                    Date:  
 

 
 
 
Page 6 of 6 
 
Statement by Investigator 
 
 
 
I have explained the project and the implications of participation in it to this 
volunteer and I believe that the consent is informed and that he/she understands the 
implications of participation. 
 
Name of Investigator:  
 
Signature:                                                                                    Date:  

My-AHA RCT Protocol 
 
Page 62 
Appendix 2. PICF (RCT Intervention Group) 
 
 

 
 
       
 
 
Page 1 of 9 
 
PARTICIPANT INFORMATION SHEET – Intervention Group 
 
The My Active and Healthy Ageing (My-AHA) Randomised Control Trial to detect pre-
frailty in older adults and provide individually tailored interventions to reduce risk for 
frailty. 
 
This information sheet is for you to keep. The information sheet is long, but it is important that you read it 
carefully before you agree to participate in this study. 
 
You have successfully completed the screening assessment for this study and we have found that you meet 
all inclusion criteria for participation in the 18 month long randomised control trial study aiming to identify 
individuals at risk for frailty and to assess different interventions to reduce your risk for frailty.  
 
You have been randomly allocation to the intervention group. As a member of the intervention group you 
will be asked to undergo routine assessment every 6 months for 18 months. In between each assessment you 
will provided with an individually tailored intervention package. The intervention package will be tailored to 
target areas of relative weakness identified at each assessment across physical, cognitive, mood, social or 
nutrition. The interventions selected are safe and have been shown to improve function in these areas. Some 
of the interventions are performed individually in your own home, some will be performed in group settings. 
We will provide individual training and support before you undertake any of the interventions we 
recommend. 
 
If you are happy with the above, please continue reading this information sheet where we provide more 
detailed information regarding what participation in this study will require. Once you have read this 
information sheet, if you wish to participate in this study please complete the attached consent form. If you 
have any questions, or would like additional information about the trial, please speak with Associate 
Professor Mathew Summers either in person, or by telephone on 5456 3758. A/Prof Summers is the 
Principal Investigator and trial site coordinator for the Australian trial. 
 
 

 
 
       
 
 
Page 2 of 9 
The My-AHA randomised control trial is a multi-site, multi-national study. The Australian trial site is being 
conducted by: 
 
 Associate Professor Mathew Summers (Principal Investigator and Trial Site Coordinator - Australia), 
Associate Professor of Neuropsychology & Mental Health, Sunshine Coast Mind and Neuroscience – 
Thompson Institute, University of the Sunshine Coast  
 
There are other trial sites involved in this study from: 
 Italy 
 Austria 
 Spain 
 Germany 
 United Kingdom 
 Belgium 
 Sweden 
 
The Australian trial site is being coordinated from the Sunshine Coast Mind and Neuroscience - Thompson 
Institute; a research institute of the University of the Sunshine Coast which is located at 12 Innovation 
Parkway, Birtinya.  
 
 
1. ‘What is the purpose of this study?’ 
Older adults with physical frailty are at increased risk of falls and other secondary complications. Frail older 
adults experience a loss of independence and increasing need for residential care. There is evidence to 
suggest that it is possible to reverse this risk by targeting a person’s risk factors for developing frailty before 
frailty appears. The aim of this study is to test a new platform that we have developed to monitor an 
individual’s risk for frailty in physical function (e.g. balance), cognition (e.g. memory), mood (e.g. 
depression), social activity (e.g. isolation), and nutrition (e.g. healthy eating). We will then develop a risk 
profile for each individual that recognises their specific areas of risk across these domains. This will results 
in our platform recommending specific activities (e.g. physical exercises, social activities in groups, diet 
changes) that will target the specific areas of risk for that individual participant.  We believe that this 
approach will lead to a significant reduction in an older adult’s risk for frailty, thereby promoting ongoing 
independence for the older adult in the community. 
 
2. ‘Why have I been invited to participate in this study?’ 
You have been invited to participate in this study as you have been screened as meeting all of the eligibility 
criteria for being a participant in the study. You have been randomly allocated to the intervention group for 
the study. 
 
 

 
 
       
 
 
Page 3 of 9 
3. ‘What does participation in this study involve?’ 
Your participation in this study will involve the following basic elements: 
1. Participation in an 18 month long study 
 
2. Undergoing comprehensive assessment on 4 occasions each spaced 6 months apart. These 
assessment will take a maximum of 3 hours to complete on each occasion. These assessment will 
occur: 
 Before you start the interventions 
 6 months later 
 12 months later 
 18 months later (completion of the intervention study) 
 
3. Undertaking recommended interventions over 18 months. You can choose how many or how few 
interventions as you like. You can do these interventions when you prefer and can space them out 
over the entire week. 
 
The Comprehensive Assessments every 6 months 
 
From your commencement in this study and every 6 months for the next 18 months we will ask you to 
undergo comprehensive assessment. Each assessment will take less than 3 hours to complete including 
regular rest breaks. 
This assessment is designed to examine your strengths and weaknesses across different aspects of: medical 
health; general health; physical functions; cognitive functions (e.g., memory); your mood; your social 
activity; your diet and nutrition; your sleeping patterns; and your experience with using technology (e.g. 
mobile telephones). 
 
These assessment are very important for two reasons: 
1. Your performances on these assessment will be used to determine your relative areas of strength and 
weakness so that we can provide an individually tailored package of interventions, designed 
specifically for you. 
2. Your performances will be monitored over time to measure how effective these interventions were in 
improving your performances in both your areas of weakness and strength. 
 
For the assessment of each area of function, we will ask you to do the following: 
a. Medical and general health 
 Complete a short questionnaire in which we will collect information regarding you recent 
medical health, medication prescriptions, educational history, residential status, relationship 
status, your history of falls, and the mental activities you have undertaken 
 Complete a questionnaire assessing how you feel your quality of life is 
 Complete a questionnaire regarding how well you perform daily activities (e.g., cooking, 
cleaning etc) 
 
b. Physical function will be assessed by a variety of questionnaires and physical function assessments 
 We will measure your weight and height 
 We will measure the strength of your hand grip with each hand 
 We will assess how long it takes for you to: 
i. Walk 4 meters 
ii. Walk for 6 minutes 

 
 
       
 
 
Page 4 of 9 
iii. Stand up and sit down 
iv. Perform two tasks at once 
 We will assess how well you can balance, and how well you can stand from sitting 
 Complete a series of questionnaires that assess your level of physical tiredness, the enjoyment 
you have when doing physical activity, and how good you feel about yourself when doing 
physical activities 
 
c. Cognitive performances will be assessed using a variety of paper-and-pencil and computer based 
tasks: 
 We will screen your general cognitive functions – such as naming things and short term 
memory 
 We will assess your capacity to learn and recall a list of 12 words that we will read out to you 
 We will assess your capacity to remember the location of objects to measure your short term 
memory 
 We will assess how fast you can perform a join-the-dots task 
 We will assess you reading speed for words and colours 
 We will assess how fast you can transcribe in writing shapes for numbers 
 
d. Mood 
 We will ask you to complete a questionnaire to assess your mood have been feeling over the 
preceding week. 
 
e. Social activity 
 Complete a questionnaire that asks you about your network of friends and family 
 Complete a questionnaire that asks you to describe how you feel about your social 
relationships 
 
f. Nutrition 
 Complete a short questionnaire that asks you about your diet 
 
g. Sleep 
 Complete a short questionnaire that asks you about how you have been sleeping recently. 
 
 
 

 
 
       
 
 
Page 5 of 9 
The Interventions 
 
Once we have examined the results of your first assessment, we will provide you with a individually tailored 
intervention package for you to undertake until the next assessment point. Following each assessment we 
will reconfigure the intervention package; meaning that the interventions you are provided may change from 
assessment to assessment. These changes will be a response to changes in the areas of strength and weakness 
we identify at each assessment point. 
There are a wide range of interventions we will make available to you. These interventions have strong 
research indicating that they are safe and effective to use. Precisely which intervention(s) you will receive 
will depend on your individual assessment results; but your intervention(s) will be selected from the 
following range of options and you can choose how much or little you do of these recommended 
interventions: 
 
a. Physical interventions will be selected from 
 A home-based exercise program, we will provide individual training after whgich you can 
undertake these exercises in your own home without assistance.  
i. Strength training 
ii. Balance training 
iii. Endurance and fitness training where you can choose your preferred form of activity 
(e.g. walking, bicycling, stationary bicycle, treadmill etc) 
 A group-based exercise program. We will invite you to a group exercise class at a central 
location which will be conducted by a trained and experienced fitness and exercise instructor. 
All activities will be tailored to your own level of fitness and ability and will be supervised at 
all times. Exercising in a group of other participants in this study can be a great social activity 
as well. 
 An endurance exercise program which you will undertake once per week and can choose 
your own activity to perform for up to 150 minutes per week (e.g. walking, bicycling, 
treadmill, stationary bicycling, etc). 
 
b. Cognitive interventions are all based on computer training or computer game type activities. As 
your performances improve the tasks increase in difficulty – ensuring that the mental challenge 
increases to further improve your cognitive performance: 
 N-Back training – is a computer training program that requires you to remember a series of 
visual pictures and to match against ones that you have previously seen. This is a powerful, 
but challenging, method of training your working memory and attention and concentration. 
 Attention bias modification training is a computer training program that trains your brain to 
direct attention to a positive visual picture and to ignore a negative picture. 
 
c. Psychosocial interventions are all based on participating in group activities, wither in person or 
through an online platform 
 Group activities can be selected from a range of options such as: group physical exercise 
classes; group cooking classes; or group excursions. 
 Support groups will be connected for specific personal issues you may be experiencing, e.g. 
bereavement support, or support groups for specific diseases 
 An online social platform will enable you to share information and chat with other 
participants in the My-AHA study from across the multiple study sites over Europe as well as 
the local site on the Sunshine Coast. 
 

 
 
       
 
 
Page 6 of 9 
d. Nutritional interventions will be provided through a nutrition application on your mobile 
telephone. This application generates individual meal plans as well as nutritional advice and 
education which are tailored to meet your needs. When you record what you eat on the nutritional 
application, new meal plans and advice are generated to match your preferences. 
 
4. ‘Is information about me confidential and can I withdraw from the study?’ 
It is important that you understand that your involvement in the study is voluntary. While we would be 
pleased to have you participate, we respect your right to decline. There are no consequences to you if you 
decide not to participate. If you decide to discontinue participation at any time, you may do so without 
providing an explanation. All information will be treated in a confidential manner, and your name will not 
be used in any publication arising out of the research. All of the research will be kept as secure computer 
files by A/Prof Summers, and only A/Prof Summers will have full access to re-identifiable information.  
 
5. ‘Are there any possible benefits from participation in this study?’ 
You were selected to participate in this study as you were identified as meeting the eligibility criteria for 
participation. One of the key eligibility criteria for all participants is that they display evidence of “pre-
frailty”. Pre-frailty is a state in which a person displays some (but not all) of the features of frailty, and the 
features the person displays are mild in nature not meeting the diagnosis of frailty. Pre-frailty can be 
considered to be a state of increased risk for developing frailty – but being pre-frail does mean a person will 
always become frail. 
 
The study you are participating in is designed to deliver individually tailored interventions targeting your 
areas of risk for frailty. These interventions have been shown to be effective and safe in other research, 
however this is the first time that we will tailor your interventions based on your individual risk for frailty. A 
major benefit of participation in this study is the potential to significantly reduce your risk for develop frailty 
and potentially to prevent you developing frailty in later life. 
Further, the data we collect during this research will be used to develop a final My-AHA platform for 
detecting and treating older adults with pre-frail risk across Australia and Europe. Your participation is 
essential to ensure that the final My-AHA platform developed is effective and easy to use. 
 
6. ‘Are there any possible risks from participation in this study?’ 
There are no significant harms or risk associated with participating in this study. The interventions were will 
recommend have been selected for their safety and effectiveness. We will provide individual training on 
each intervention that is recommended to you and modify the interventions to suit your own level of ability 
and preferences. 
 
The assessment tasks used at 6 monthly intervals include measures that are challenging and designed to push 
you to your level of best performance. Consequently, you may find that each test becomes more difficult and 
harder to complete. While this may be frustrating, it is necessary for our testing to push you so that we can 
determine what your best performance is. In addition you will be asked to complete some questionnaires 
relating to your emotions and feelings. Some people may experience some discomfort reporting their 
emotional states. 
 
Disclosing personal information 
 You will be asked to complete some questionnaires relating to your personal life (e.g. education, family, 
occupation) and medical history. Some people may feel discomfort in disclosing personally sensitive 
information. We require this information as these factors are known to contribute to your performance, 

 
 
       
 
 
Page 7 of 9 
so our knowledge of whether these factors are present will enable us to more accurately interpret your 
results. 
 Your information will be treated as confidential and will be de-identified to protect your privacy. Your 
de-identified data will be combined with de-identified data from all the other study sites o that we can 
analyse the effectiveness of our intervention program across counties. No individual information will be 
presented in any papers coming from this project, only summary data from the entire group will be 
reported, ensuring that your personal information cannot be identified. Only A/Prof Mathew Summers is 
able to re-identify your data, no other research personnel will be able to identify which data belongs to 
you, or who you are. 
 
7. ‘How is this research funded?’ 
The Australian study site at the Sunshine Coast Mind and Neuroscience – Thompson Institute is funded by a 
National Health and Medical Research Council (NHMRC) European Union Project Grant (1115818) 
awarded to A/Prof Mathew Summers as Chief Investigator. 
The European trial sites are funded by a European Commission HORIZON2020 Consortium GHrant, on 
which A/Prof Summers is a Principal Investigator. 
 
8. ‘What if I have questions about this research?’ 
If you would like to discuss any aspect of this research please feel free to contact A/Prof Mathew Summers 
on 5456 3758, or email msummers@usc.edu.au. A/Prof Summers would be happy to discuss any aspect of 
the research with you. You are welcome to contact A/Prof Summers at any time to discuss any issue relating 
to the research study.  
 
This study has been approved by the Human Research Ethics Committee (Ethics approval number: 
********).  If you have concerns or complaints about the conduct of this study you can raise them with the 
Principal Investigator (A/Prof Mathew Summers). If you prefer an independent person, contact the 
Chairperson of the Human Research Ethics Committee at the University of the Sunshine Coast: (c/- the 
Research Ethics Officer, Office of Research, University of the Sunshine Coast, Maroochydore DC, 4558; 
telephone (07) 5459 4574; email humanethics@usc.edu.au. You will need to quote HREC project HREC 
**** My Active and Healthy Ageing (My-AHA) randomised control trial study. 
 
On behalf of A/Prof Mathew Summers, the European Consortium partners, and the University of the 
Sunshine Coast, we thank you for taking the time to consider participating in this study.  
 
If you wish to participate, please sign the attached consent form. This information sheet is for you to keep. 

 
 
       
 
 
Page 8 of 9 
CONSENT FORM 
TITLE OF PROJECT: 
The My Active and Healthy Ageing (My-AHA) Randomised Control Trial to detect pre-frailty in 
older adults and provide individually tailored interventions to reduce risk for frailty 
 
1. I have read and understood the ‘Information Sheet’ for this project. 
2. I understand that I have been randomly allocated to the intervention group and consent to being a 
participant in the intervention group. 
3. The nature and possible effects of the study have been explained to me. 
4. I understand what my participation in this study involves as outlined in the ‘Participant Information 
Sheet’ 
5. I understand that involvement in this study involves undergoing 4 assessment sessions spaced 6 months 
apart over 18 months, and that each session will take no more than 3 hours to complete including regular 
rest breaks.  
6. I understand that in these assessment sessions I will be asked to provide information regarding my 
demographic information, medical history, occupational and educational history, quality of life, sleep 
habits, social activity, and diet and nutrition. I understand that my physical functions (e.g balance), 
cognitive functions (e.g. memory) and psychological wellbeing (e.g. mood) will be assessed.  
7. I understand that I will be provided with an individually tailored intervention program which I can 
choose to do as much or as little of as I want. These interventions will be selected from physical 
exercises, cognitive training games, group activities, and/or nutritional advice. I understand that these 
interventions will be performed at home by myself, in a group class setting, in a group-based activity, or 
by using an application on my mobile telephone. 
8. I understand that the assessment measures as well as the interventions I am asked to perform are 
designed to become increasingly difficulty as my abilities improve and that I may experience some 
frustration as the difficulty increases. 
9. I understand that should I experience any discomfort, dizziness, faintness, breathlessness or illness 
during the either the assessments or while undertaking the intervention I must notify the researcher 
immediately, so that they can stop the procedure immediately.  
10. I understand that information that identifies me will be removed and all information will be retained as 
confidential and will only be used for the purposes of the research project. 
11. I understand that throughout the course of this study I will be provided with feedback as to how I am 
performing and how the interventions I have completed have modified my risk for developing frailty.  
12. Any questions that I have asked have been answered to my satisfaction.  
13. I agree that the research data gathered from me for the study may be published provided that I cannot be 
identified as a participant. 
14. I agree that my de-identified data from this research can be used in future research projects. 

 
 
       
 
 
Page 9 of 9 
15. I agree that my data (de-identified) can be shared with other researchers involved in the My-AHA 
consortium. 
16. I agree to participate in this investigation and that I may withdraw at any time without any effect or 
explanation, and if I so wish, may request that any data I have supplied to date be withdrawn from the 
research.  
 
Name of Participant:  
 
 
Signature:                                                                                    Date:  
 
 
Statement by Investigator 
 
 
 
I have explained the project and the implications of participation in it to this 
volunteer and I believe that the consent is informed and that he/she understands the 
implications of participation. 
 
Name of Investigator:  
 
 
Signature:                                                                                    Date:  
 
 

My-AHA RCT Protocol 
 
Page 70 
Appendix 3. PICF (RCT Control Group) 
 

 
 
 
Page 1 of 8 
PARTICIPANT INFORMATION SHEET – Control Group 
 
The My Active and Healthy Ageing (My-AHA) Randomised Control Trial to detect pre-
frailty in older adults and provide individually tailored interventions to reduce risk for 
frailty. 
 
This information sheet is for you to keep. The information sheet is long, but it is important that you read it 
carefully before you agree to participate in this study. 
 
You have successfully completed the screening assessment for this study and we have found that you meet 
all inclusion criteria for participation in the 18 month long randomised control trial study aiming to identify 
individuals at risk for frailty and to assess different interventions to reduce your risk for frailty.  
 
You have been randomly allocation to the control (no treatment) group. As a member of the control group 
you will be asked to undergo routine assessment every 6 months for 18 months. In the event that you 
develop clinical symptoms of frailty during this 18 month trial we will immediately offer you the 
opportunity to transfer to the intervention group which is assessing the ability of an individually tailored 
intervention package to reduce signs and symptoms of frailty. However, as this is a randomised control trial 
designed to test whether the intervention package has efficacy in helping older adults manage changes in 
physical, cognitive, social, and psychological function, it is imperative that we have a comparison group 
who do not receive this intervention package. Note, you may continue to do any or all of the activities you 
currently do which you may have chosen improve your health and fitness; we do not require you to cease 
any activities you are currently doing and will not ask you to not undertake any other activities you choose 
to do in the future. 
 
At the conclusion of the study, we will determine if our intervention package is successful and aim to make 
this a commercially available product. As a participant in this study you will be the first to be informed of 
these results and whether the intervention package has been developed for people to obtain and use. 
 
If you are happy with the above, please continue reading this information sheet where we provide more 
detailed information regarding what participation in this study will require. Once you have read this 
information sheet, if you wish to participate in this study please complete the attached consent form. If you 
have any questions, or would like additional information about the trial, please speak with Associate 
Professor Mathew Summers either in person, or by telephone on 5456 3758. A/Prof Summers is the 
Principal Investigator and trial site coordinator for the Australian trial. 
 
 

 
 
 
Page 2 of 8 
The My-AHA randomised control trial is a multi-site, multi-national study. The Australian trial site is being 
conducted by: 
 
 Associate Professor Mathew Summers (Principal Investigator and Trial Site Coordinator - Australia), 
Associate Professor of Neuropsychology & Mental Health, Sunshine Coast Mind and Neuroscience – 
Thompson Institute, University of the Sunshine Coast  
 
There are other trial sites involved in this study from: 
 Italy 
 Austria 
 Spain 
 Germany 
 United Kingdom 
 Belgium 
 Sweden 
 
The Australian trial site is being coordinated from the Sunshine Coast Mind and Neuroscience - Thompson 
Institute; a research institute of the University of the Sunshine Coast which is located at 12 Innovation 
Parkway, Birtinya.  
 
 
1. ‘What is the purpose of this study?’ 
Older adults with physical frailty are at increased risk of falls and other secondary complications. Frail older 
adults experience a loss of independence and increasing need for residential care. There is evidence to 
suggest that it is possible to reverse this risk by targeting a person’s risk factors for developing frailty before 
frailty appears. The aim of this study is to test a new platform that we have developed to monitor an 
individual’s risk for frailty and to provide recommended interventions to reduce the risk for frailty in 
physical function (e.g. balance), cognition (e.g. memory), mood (e.g. depression), social activity (e.g. 
isolation), and nutrition (e.g. healthy eating).  
 
As a member of the control group we will monitor your health and function over 18 months without 
providing you access to the intervention package. We will provide your results to you following each 
assessment which you can discuss with us and your medical practitioner if you choose. It is important to 
note, we will not ask you to stop doing any activities that you currently are doing, or intend to do in the 
future, to improve your health or fitness.  
 
If we detect a significant change in your functions over the 18 month trial that indicate you are developing 
signs of frailty, we will immediately offer you the opportunity to join the intervention and have full access to 
the intervention package. We do yet not know whether these interventions are effective in reducing 
symptoms of frailty as this is the purpose of this study. 
 
2. ‘Why have I been invited to participate in this study?’ 
You have been invited to participate in this study as you have been screened as meeting all of the eligibility 
criteria for being a participant in the study. You have been randomly allocated to the control (no treatment) 
group for the study. 
 
 
 

 
 
 
Page 3 of 8 
3. ‘What does participation in this study involve?’ 
Your participation in this study will involve the following basic elements: 
1. Participation in an 18 month long study 
 
2. Undergoing comprehensive assessment on 4 occasions each spaced 6 months apart. These 
assessment will take a maximum of 3 hours to complete on each occasion. These assessment will 
occur: 
 Before you start the interventions 
 6 months later 
 12 months later 
 18 months later (completion of the intervention study) 
 
The Comprehensive Assessments every 6 months 
 
From your commencement in this study and every 6 months for the next 18 months we will ask you to 
undergo comprehensive assessment. Each assessment will take less than 3 hours to complete including 
regular rest breaks. 
This assessment is designed to examine your strengths and weaknesses across different aspects of: medical 
health; general health; physical functions; cognitive functions (e.g., memory); your mood; your social 
activity; your diet and nutrition; your sleeping patterns; and your experience with using technology (e.g. 
mobile telephones). 
 
These assessment are very important for two reasons: 
1. Your performances on these assessment will be used to determine your relative areas of strength and 
weakness so that we can provide an individually tailored package of interventions, designed 
specifically for you. 
2. Your performances will be monitored over time to measure how effective these interventions were in 
improving your performances in both your areas of weakness and strength. 
 
For the assessment of each area of function, we will ask you to do the following: 
a. Medical and general health 
 Complete a short questionnaire in which we will collect information regarding you recent 
medical health, medication prescriptions, educational history, residential status, relationship 
status, your history of falls, and the mental activities you have undertaken 
 Complete a questionnaire assessing how you feel your quality of life is 
 Complete a questionnaire regarding how well you perform daily activities (e.g., cooking, 
cleaning etc) 
 
b. Physical function will be assessed by a variety of questionnaires and physical function assessments 
 We will measure your weight and height 
 We will measure the strength of your hand grip with each hand 
 We will assess how long it takes for you to: 
i. Walk 4 meters 
ii. Walk for 6 minutes 
iii. Stand up and sit down 
iv. Perform two tasks at once 
 We will assess how well you can balance, and how well you can stand from sitting 
 Complete a series of questionnaires that assess your level of physical tiredness, the enjoyment 
you have when doing physical activity, and how good you feel about yourself when doing 
physical activities 

 
 
 
Page 4 of 8 
 
c. Cognitive performances will be assessed using a variety of paper-and-pencil and computer based 
tasks: 
 We will screen your general cognitive functions – such as naming things and short term 
memory 
 We will assess your capacity to learn and recall a list of 12 words that we will read out to you 
 We will assess your capacity to remember the location of objects to measure your short term 
memory 
 We will assess how fast you can perform a join-the-dots task 
 We will assess you reading speed for words and colours 
 We will assess how fast you can transcribe in writing shapes for numbers 
 
d. Mood 
 We will ask you to complete a questionnaire to assess your mood have been feeling over the 
preceding week. 
 
e. Social activity 
 Complete a questionnaire that asks you about your network of friends and family 
 Complete a questionnaire that asks you to describe how you feel about your social 
relationships 
 
f. Nutrition 
 Complete a short questionnaire that asks you about your diet 
 
g. Sleep 
 Complete a short questionnaire that asks you about how you have been sleeping recently. 
 
h. Technology 
 Complete occasional questionnaire that ask you to describe how you feel about using 
different technologies (e.g. mobile telephones, computers etc). 
 
 
4. ‘Is information about me confidential and can I withdraw from the study?’ 
It is important that you understand that your involvement in the study is voluntary. While we would be 
pleased to have you participate, we respect your right to decline. There are no consequences to you if you 
decide not to participate. If you decide to discontinue participation at any time, you may do so without 
providing an explanation. All information will be treated in a confidential manner, and your name will not 
be used in any publication arising out of the research. All of the research will be kept as secure computer 
files by A/Prof Summers, and only A/Prof Summers will have full access to re-identifiable information.  
 
5. ‘Are there any possible benefits from participation in this study?’ 
You were selected to participate in this study as you were identified as meeting the eligibility criteria for 
participation. One of the key eligibility criteria for all participants is that they display evidence of “pre-
frailty”. Pre-frailty is a state in which a person displays some (but not all) of the features of frailty, and the 
features the person displays are mild in nature not meeting the diagnosis of frailty. Pre-frailty can be 
considered to be a state of increased risk for developing frailty – but being pre-frail does mean a person will 
always become frail. 
 
The study you are participating in is designed to deliver individually tailored interventions targeting your 
areas of risk for frailty. As a member of the control group you will not have access to the intervention 

 
 
 
Page 5 of 8 
package. However, should we detect a significant change in your functions across assessments indicating 
that you may be developing clinical frailty, we will immediately offer you the opportunity to transfer to the 
intervention group where you will be provided with full access to the intervention package. This may help 
reduce symptoms of frailty, however, we cannot be sure that this will occur as the purpose of this study is to 
test whether the intervention package actually does reduce symptoms of frailty. 
Further, the data we collect during this research will be used to develop a final My-AHA platform for 
detecting and treating older adults with pre-frail risk across Australia and Europe. Your participation is 
essential to ensure that the final My-AHA platform developed is effective and easy to use. 
 
6. ‘Are there any possible risks from participation in this study?’ 
There are no significant harms or risk associated with participating in this study. The assessment tasks used 
at 6 monthly intervals include measures that are challenging and designed to push you to your level of best 
performance. Consequently, you may find that each test becomes more difficult and harder to complete. 
While this may be frustrating, it is necessary for our testing to push you so that we can determine what your 
best performance is. In addition you will be asked to complete some questionnaires relating to your 
emotions and feelings. Some people may experience some discomfort reporting their emotional states. 
 
Disclosing personal information 
 You will be asked to complete some questionnaires relating to your personal life (e.g. education, family, 
occupation) and medical history. Some people may feel discomfort in disclosing personally sensitive 
information. We require this information as these factors are known to contribute to your performance, 
so our knowledge of whether these factors are present will enable us to more accurately interpret your 
results. 
 Your information will be treated as confidential and will be de-identified to protect your privacy. Your 
de-identified data will be combined with de-identified data from all the other study sites o that we can 
analyse the effectiveness of our intervention program across counties. No individual information will be 
presented in any papers coming from this project, only summary data from the entire group will be 
reported, ensuring that your personal information cannot be identified. Only A/Prof Mathew Summers is 
able to re-identify your data, no other research personnel will be able to identify which data belongs to 
you, or who you are. 
 
7. ‘How is this research funded?’ 
The Australian study site at the Sunshine Coast Mind and Neuroscience – Thompson Institute is funded by a 
National Health and Medical Research Council (NHMRC) European Union Project Grant (1115818) 
awarded to A/Prof Mathew Summers as Chief Investigator. 
The European trial sites are funded by a European Commission HORIZON2020 Consortium GHrant, on 
which A/Prof Summers is a Principal Investigator. 
 
 

 
 
 
Page 6 of 8 
8. ‘What if I have questions about this research?’ 
If you would like to discuss any aspect of this research please feel free to contact A/Prof Mathew Summers 
on 5456 3758, or email msummers@usc.edu.au. A/Prof Summers would be happy to discuss any aspect of 
the research with you. You are welcome to contact A/Prof Summers at any time to discuss any issue relating 
to the research study.  
 
This study has been approved by the Human Research Ethics Committee (Ethics approval number: 
********).  If you have concerns or complaints about the conduct of this study you can raise them with the 
Principal Investigator (A/Prof Mathew Summers). If you prefer an independent person, contact the 
Chairperson of the Human Research Ethics Committee at the University of the Sunshine Coast: (c/- the 
Research Ethics Officer, Office of Research, University of the Sunshine Coast, Maroochydore DC, 4558; 
telephone (07) 5459 4574; email humanethics@usc.edu.au. You will need to quote HREC project HREC 
**** My Active and Healthy Ageing (My-AHA) randomised control trial study. 
 
 
On behalf of A/Prof Mathew Summers, the European Consortium partners, and the University of the 
Sunshine Coast, we thank you for taking the time to consider participating in this study.  
 
 
If you wish to participate, please sign the attached consent form. This information sheet is for you to keep. 

 
 
 
Page 7 of 8 
CONSENT FORM 
 
 
TITLE OF PROJECT: 
The relationship between vascular processes and neurocognitive function in non-stroke 
cardiovascular disease: A prospective longitudinal investigation  
 
TITLE OF PROJECT: 
The My Active and Healthy Ageing (My-AHA) Randomised Control Trial to detect pre-frailty in 
older adults and provide individually tailored interventions to reduce risk for frailty 
 
1. I have read and understood the ‘Information Sheet’ for this project. 
2. I understand that I have been randomly allocated to the control (no treatment) group and consent to 
being a participant in the control group. 
3. I understand that I will not be asked to cease any activities I am currently doing or choose to do in the 
future, and that these choices will not affect my participation in this study. 
4. I understand that should a significant decline in my function be detected, suggesting development of 
clinical frailty, I will be offered the opportunity to transfer into the intervention group where I will 
receive access to the full intervention package being tested. 
5. I understand that there is no guarantee that the intervention package will reduce symptoms of frailty. 
6. The nature and possible effects of the study have been explained to me. 
7. I understand what my participation in this study involves as outlined in the ‘Participant Information 
Sheet’ 
8. I understand that involvement in this study involves undergoing 4 assessment sessions spaced 6 months 
apart over 18 months, and that each session will take no more than 3 hours to complete including regular 
rest breaks.  
9. I understand that in these assessment sessions I will be asked to provide information regarding my 
demographic information, medical history, occupational and educational history, quality of life, sleep 
habits, social activity, and diet and nutrition. I understand that my physical functions (e.g balance), 
cognitive functions (e.g. memory) and psychological wellbeing (e.g. mood) will be assessed.  
10. I understand that the assessment measures I am asked to perform are designed to become increasingly 
difficulty as my abilities improve and that I may experience some frustration as the difficulty increases. 
11. I understand that information that identifies me will be removed and all information will be retained as 
confidential and will only be used for the purposes of the research project. 

 
 
 
Page 8 of 8 
12. I understand that throughout the course of this study I will be provided with feedback as to how I am 
performing and how the interventions I have completed have modified my risk for developing frailty.  
13. Any questions that I have asked have been answered to my satisfaction.  
14. I agree that the research data gathered from me for the study may be published provided that I cannot be 
identified as a participant. 
15. I agree that my de-identified data from this research can be used in future research projects. 
16. I agree that my data (de-identified) can be shared with other researchers involved in the My-AHA 
consortium. 
17. I agree to participate in this investigation and that I may withdraw at any time without any effect or 
explanation, and if I so wish, may request that any data I have supplied to date be withdrawn from the 
research.  
 
Name of Participant:  
 
 
Signature:                                                                                    Date:  
 
 
Statement by Investigator 
 
 
 
I have explained the project and the implications of participation in it to this 
volunteer and I believe that the consent is informed and that he/she understands the 
implications of participation. 
Name of Investigator:  
 
 
Signature:                                                                                    Date:  
 
 
 

My-AHA RCT Protocol 
 
Page 81 
Appendix 4. Screening Assessment Checklist 
 

My-AHA PARTICIPANT SCREENING ASSESSMENT PACKAGE 
 
Page 82 
 
To be completed by Investigator interview of potential participant: 
 
1 
Date of Birth 
DD / MM / YYYY 
 
2 
Age (years) 
 
If 60 years or older proceed 
If <60 yrs - EXCLUDE 
3a 
Able to stand and walk unassisted 
YES / NO 
If YES – proceed 
If NO - EXCLUDE 
3b 
Painful arthritis, spinal stenosis, amputation, or 
painful foot lesions that limit balance and mobility. 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
4a 
suffers from a significant neurodegenerative CNS 
disorder, e.g. Alzheimer’s disease, Lewy body 
dementia, Frontotemporal Lobar Degeneration, 
Fronto-Temporal Dementia, Parkinson’s disease, 
multiple sclerosis, progressive supranuclear palsy, 
amyotrophic lateral sclerosis, hydrocephalus, 
Huntington’s disease, prion diseases 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
4b 
affected by severe peripheral nervous system and/or 
neuromuscular disorders, e.g. CIDP, myasthenia 
gravis, multiple sclerosis, polymyositis 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
5a 
clinical evidence or history of stroke (within 2 yrs) 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
5b 
clinical evidence or history of transient ischemic 
attack (within 6 months) 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
5c 
significant head injury with associated loss of 
consciousness, skull fracture or persisting cognitive 
impairment (2 years) 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
5d 
epilepsy (a single prior seizure is considered 
acceptable) 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
5e 
if meet DSM-5 criteria for: major depressive disorder 
(current), schizophrenia or other psychotic disorders 
(lifetime), bipolar disorder (within the past 5 years), 
substance (including alcohol) related disorders 
(within the past 2 years) 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
6a 
have language deficits that impair testing 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
6b 
have significant visual impairment 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
6c 
have a significant hearing loss 
YES / NO 
If YES – EXCLUDE 

My-AHA PARTICIPANT SCREENING ASSESSMENT PACKAGE 
 
Page 83 
If NO - proceed 
7a 
have clinically significant cardiovascular disease, i.e: 
hospitalization for acute coronary syndrome (acute 
myocardial infarction or unstable, angina), symptoms 
consistent with angina pectoris (within the 12 
months), signs or symptoms of clinical heart failure 
within the 12 months, evidence of uncontrolled atrial 
fibrillation, a cardiac pacemaker 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
7b 
preexisting or current signs or symptoms of 
respiratory failure, e.g. chronic obstructive 
pulmonary disease, bronchial asthma, lung fibrosis, 
other respiratory disease 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
7c 
untreated hypertension 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
7d 
metastatic cancer or immunosuppressive therapy 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
7e 
concurrent acute or chronic clinically significant 
immunologic, hepatic (such as presence of 
encephalopathy or ascites), or endocrine disease (not 
adequately treated). 
YES / NO 
If YES – EXCLUDE 
If NO - proceed 
8 
Prescription medication other than for treating 
conditions in 3b to 7e 
 
 
 
 
 
 
Confirm participant can proceed into 
RCT with medical monitor if other 
medications are reported 
9 
Postural hypotension at the time of screening.   
 
Participants who present at the time of screening with 
postural hypotension yet have no known history of 
postural hypotension, nor underlying medical 
condition related to hypotension, may be rescreened 
BP sitting 
Sys = ______ 
Dias = _____ 
 
BP standing 
Sys = ______ 
Dias = _____ 
Standing systolic BP >30mgHG 
lower than sitting systolic BP - 
EXCLUDE 
and/or 
Standing diastolic BP >20mmHg 
lower than sitting diastolic BP - 
EXCLUDE 
 
If does not meet above - proceed 
10 
Legally able to consent 
YES / NO 
If YES – proceed 
If NO - EXCLUDE 
11 
Gender 
Male / Female 
 
12 
Height 
________  m 
 

My-AHA PARTICIPANT SCREENING ASSESSMENT PACKAGE 
 
Page 84 
13 
Weight 
_______   kg 
 
14 
BMI 
__________ 
[height(m)/weight (kg)] / [height(m)] 
15 
Able to use smartphone and/or tablet computer 
 
If YES – proceed 
If NO – EXCLUDE 
15a Owns own smartphone/tablet computer 
YES / NO 
Model: _____________________ 
OS: Android / Win  / Mac 
15b Has existing mobile plan and provider? 
YES / NO 
Provider: ___________________ 
Data/mth: __________________ 
15c Has WiFi access at place of residence? 
YES / NO 
 
15d Has existing internet provider and plan? 
 
Provider: ___________________ 
Data/mth: __________________ 
 
 
 
 

My-AHA PARTICIPANT SCREENING ASSESSMENT PACKAGE 
 
Page 85 
 
PHYSICAL FRAILTY ASSESSMENT 
 
1 
Self-reported weight loss (not due to dieting or fasting) in preceding 12 mo ≥ 4.5 kg 
YES / NO 
2 
Grip strength measured using 
dynanometer 
Sex 
BMI 
Grip strength 
cutoff (kg) 
Is grip stength below 
cutoff for sex/age? 
 
YES / NO 
Male 
≤ 24 
≤ 29 
 
24.1 - 26 
≤ 30 
 
26.1 - 28 
≤ 30 
 
> 28 
≤ 32 
Female 
≤ 23 
≤ 17 
 
23.1 - 26 
≤ 17.3 
 
26.1 - 29 
≤ 18 
 
> 29 
≤ 21 
3a 
Ask participant 
“How often over the past week have you 
felt that everything you did was an 
effort?” 
0 = rarely or none of the time (<1 day) 
1 = Some or a little of time (1-2 days) 
2 = Occaisionally or a moderate amount of time 
(3-4 days) 
3 = Most or all of the time (5-7 days) 
Score 2 or 3 
 
YES / NO 
3b 
Ask participant 
“How often over the past week have you 
felt that you could not get “going”?” 
0 = rarely or none of the time (<1 day) 
1 = Some or a little of time (1-2 days) 
2 = Occaisionally or a moderate amount of time 
(3-4 days) 
3 = Most or all of the time (5-7 days) 
Score 2 or 3 
 
YES / NO 
4 
Time to walk 15ft (4.57m) ≤ slowest 
20% adjusted for gender and standing 
height 
Sex 
Height (cm) 
Cutoff time 
to walk 15ft 
Is time to walk 
greater than cutoff 
for sex/height? 
 
YES / NO 
Male 
≤ 173  
≥ 7 sec 
 
> 173  
≥ 6 sec 
Female 
≤ 159  
≥ 7 sec 
 
>159  
≥ 6 sec 
5 
IPAQ Short Version Activity Level 
______________ MET-min 
Kcal 
[kcal = MET-min x 
(wight kg / 60)] 
 
Cutoff 
Is activity level 
(kcal) below cutoff 
for gender? 
YES / NO 
Men 
< 383 kcal 
Women 
< 270 kcal 
 
 
TOTAL NUMBER OF “YES” 
/  5 
 
 
 
If 1 or 2 YES 
Include 
 
 
 
If 0 or >2 YES 
EXCLUDE 
 
 
 
 

My-AHA PARTICIPANT SCREENING ASSESSMENT PACKAGE 
 
Page 86 
 
COGNITIVE FRAILTY ASSESSMENT 
 
1 
MMSE Raw Score               = _____ / 30 
 
MMSE Age-adjusted Score = _____ / 30 
Age-Adjusted Score ≤ 26 
YES / NO 
2 
Hopkins Verbal Learning Test (HVLT) 
 
HVLT total recall score = _______ / 36 
HVLT total recall score ≤ 24 
YES / NO 
 
 
TOTAL NUMBER OF “YES” 
/  2 
 
 
 
If 0 YES 
Include 
 
 
 
If 1 or 2 YES 
EXCLUDE 
 
 
PSYCHOLOGICAL FRAILTY ASSESSMENT 
 
1 
HADS Anxiety Score          = _____ / 21 
HADS Anxiety Score ≥ 15 
YES / NO 
2 
HADS Depression Score     = _____ / 21 
HADS Depression Score ≥ 15 
YES / NO 
 
 
TOTAL NUMBER OF “YES” 
/  2 
 
 
 
If 0 YES 
Include 
 
 
 
If 1 or 2 YES 
EXCLUDE 
 

INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE 
(IPAQ) 
 
Page 87 
PARTICIPANT SCREEN NUMBER:  _______________ 
STUDY SITE: 
____________________________________ 
TEST PHASE: 
Screening 
 
We are interested in finding out about the kinds of physical activities that people do as part of their everyday 
lives.  The questions will ask you about the time you spent being physically active in the last 7 days.  Please 
answer each question even if you do not consider yourself to be an active person.  Please think about the 
activities you do at work, as part of your house and yard work, to get from place to place, and in your spare 
time for recreation, exercise or sport. 
 
Think about all the vigorous activities that you did in the last 7 days.  Vigorous physical activities refer to 
activities that take hard physical effort and make you breathe much harder than normal.  Think only about 
those physical activities that you did for at least 10 minutes at a time. 
 
1. 
During the last 7 days, on how many days did you do vigorous physical activities like heavy lifting, 
digging, aerobics, or fast bicycling?  
 
_____ days per week 
 
 
 
  
No vigorous physical activities 
 
Skip to question 3 
 
 
2. 
How much time did you usually spend doing vigorous physical activities on one of those days? 
 
_____ hours per day 
_____ minutes per day 
 
 
 
 
Don’t know/Not sure  
 
 
Think about all the moderate activities that you did in the last 7 days.  Moderate activities refer to 
activities that take moderate physical effort and make you breathe somewhat harder than normal.  Think 
only about those physical activities that you did for at least 10 minutes at a time. 
 
 
3. 
During the last 7 days, on how many days did you do moderate physical activities like carrying 
light loads, bicycling at a regular pace, or doubles tennis?  Do not include walking. 
 
_____ days per week 
 
 
  
No moderate physical activities 
 
Skip to question 5 
 
 
4. 
How much time did you usually spend doing moderate physical activities on one of those days? 
 
_____ hours per day 
_____ minutes per day 
 
 
 
Don’t know/Not sure  
 

INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE 
(IPAQ) 
 
Page 88 
Think about the time you spent walking in the last 7 days.  This includes at work and at home, walking to 
travel from place to place, and any other walking that you have done solely for recreation, sport, exercise, or 
leisure. 
 
5. 
During the last 7 days, on how many days did you walk for at least 10 minutes at a time?   
 
_____ days per week 
 
 
 
  
No walking  
 
  Skip to question 7 
 
 
1. 
How much time did you usually spend walking on one of those days? 
 
_____ hours per day 
_____ minutes per day 
 
 
 
 
Don’t know/Not sure  
 
 
The last question is about the time you spent sitting on weekdays during the last 7 days.  Include time spent 
at work, at home, while doing course work and during leisure time.  This may include time spent sitting at a 
desk, visiting friends, reading, or sitting or lying down to watch television. 
 
2. During the last 7 days, how much time did you spend sitting on a week day? 
 
_____ hours per day 
_____ minutes per day 
 
 
 
 
Don’t know/Not sure  
 
 
This is the end of the questionnaire, thank you for participating. 

 
Page 89 
 
 
 

 
Page 90 
 
 
 

 
Page 91 
 
 

HOPKINS VERBAL LEARNING TEST 
LIST 1 (HVLT-1) 
 
Page 92 
PARTICIPANT SCREEN NUMBER:  _______________ 
STUDY SITE: 
____________________________________ 
TEST PHASE: 
Screening 
 
Instructions: Read the list of 12 words in Part A (at a rate of 1 word every 2 seconds), then have the participant 
repeat as many of the words as s/he can recall. Do this for 3 trials. Do not warn the participant that they will be 
asked to remember these words later on.  
 
After 20-25 minutes delay continue to Part B (participant undertakes remainder of assessment for this visit). 
Complete the Delayed Recall trial by asking the participant to recall the words you read to them at the 
beginning of the test. Then complete the Recognition trial by saying each word to the participant and asking the 
participant to respond with “Yes” if the word was on the list or “no” if it was not. 
 
Part A 
Trial 1 
Trial 2 
Trial 3 
Part B 
Delayed 
Recall 
LION 
 
 
 
 
 
EMERALD 
 
 
 
 
 
HORSE 
 
 
 
 
 
TENT 
 
 
 
 
 
SAPPHIRE 
 
 
 
 
 
HOTEL 
 
 
 
 
 
CAVE 
 
 
 
 
 
OPAL 
 
 
 
 
 
TIGER 
 
 
 
 
 
PEARL 
 
 
 
 
 
COW 
 
 
 
 
 
HUT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TOTAL 
CORRECT 
 
 
 
 
 
 
 
Part B – RECOGNITION TRIAL 
 
 
Y 
N 
 
Y 
N 
 
Y 
N 
 
Y 
N 
HORSE 
 
 
EMERALD 
 
 
Balloon 
 
 
Apartment*  
 
House* 
 
 
mountain 
 
 
Boat 
 
 
COW 
 
 
HUT 
 
 
CAVE 
 
 
Dog* 
 
 
LION 
 
 
TENT 
 
 
TIGER 
 
 
HOTEL 
 
 
PEARL 
 
 
Ruby* 
 
 
SAPPHIRE 
 
 
Coffee 
 
 
Penny 
 
 
OPAL 
 
 
Cat* 
 
 
Scarf 
 
 
Diamond* 
 
 
 

Participant Screening  number:  _______________ 
  
Study Site: 
________________________ 
Test Phase: Screening 
 
 
 
 
Hospital Anxiety and Depression Scale (HADS) 
 
 
 
FOLD HERE 
Clinicians are aware that emotions play an important part in most illnesses. If your clinician knows 
about these feelings he or she will be able to help you more. 
This questionnaire is designed to help your clinician to know how you feel. Read each item below 
and underline the reply which comes closest to how you have been feeling in the past week. 
Ignore the numbers printed at the edge of the questionnaire. 
DoŶ’t take too loŶg oǀer your replies; your iŵŵediate reaĐtioŶ to eaĐh iteŵ ǁill proďaďly ďe ŵore 
accurate than a long, thought-out response. 
FOLD HERE 
 
A 
D 
 
 
A 
D 
 
 
I feel teŶse or ͚wouŶd up͛ 
I feel as if I am slowed down  
 
 
3 
 
Most of the time 
Nearly all the time 
 
3 
2 
 
A lot of the time 
Very often 
 
2 
1 
 
From time to time, occasionally 
Sometimes 
 
1 
0 
 
Not at all 
Not at all 
 
0 
 
 
 
 
 
 
 
 
I still enjoy the things I used to enjoy 
I get a sort of frightened feeling like 
͚ďutterflies͛ iŶ the stoŵaĐh 
 
 
 
0 
Definitely as much 
Not at all 
0 
 
 
1 
Not quite so much 
Occasionally 
1 
 
 
2 
Only a little 
Quite often 
2 
 
 
3 
Hardly at all 
Very often 
3 
 
 
 
 
 
 
 
 
 
I get a sort of frightened feeling as if something 
awful is about to happen 
I have lost interest in my appearance 
 
 
3 
 
Very definitely and quite badly 
Definitely 
 
3 
2 
 
Yes, but not too badly 
I doŶ’t take as ŵuĐh Đare as I should 
 
2 
1 
 
A little, ďut it doesŶ’t ǁorry me 
I may not take quite as much care 
 
1 
0 
 
Not at all 
I take just as much care as ever 
 
0 
 
 
 
 
 
 
 
 
I can laugh and see the funny side of things 
I feel restless as if I have to be on the move 
 
 
 
0 
As much as I always could 
Very much indeed 
3 
 
 
1 
Not quite so much now 
Quite a lot 
2 
 
 
2 
Definitely not so much now 
Not very much 
1 
 
 
3 
Not at all 
Not at all 
0 
 
 
 
 
 
 
 
 
 
Worrying thoughts go through my mind 
I look forward with enjoyment to things 
 
 
3 
 
A great deal of the time 
As much as I ever did 
 
0 
2 
 
A lot of the time 
Rather less than I used to 
 
1 
1 
 
Not too often 
Definitely less than I used to 
 
2 
0 
 
Very little 
Hardly at all 
 
3 
 
 
 
 
 
 
 
 
I feel cheerful 
I get sudden feelings of panic 
 
 
 
3 
Never 
Very often indeed 
3 
 
 
2 
Not often 
Quite often 
2 
 
 
1 
Sometimes 
Not very often 
1 
 
 
0 
Most of the time 
Not at all 
0 
 
 
 
 
 
 
 
 
 
I can sit at ease and feel relaxed 
I can enjoy a good book or radio or 
television programme 
 
 
0 
 
Definitely 
Often 
 
0 
1 
 
Usually 
Sometimes 
 
1 
2 
 
Not often 
Not often 
 
2 
3 
 
Not at all 
Very seldom 
 
3 
 
 
Now check that you have answered all the questions 
 
 
 
 
 
 
A 
D 
 
 
 
 
 
 
 

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Appendix 5. Standard Demographic Questionnaire 
 

 
 
Participant Code number:  _______________ 
 
 
Study Site: 
________________________ 
Test Phase: Baseline / 6mo / 12mo / 18 mo 
 
My-AHA Demographic Questionnaire - BASELINE 
 
Demographic Information 
 
Date of birth :   
DD / MM / YYYY 
Age (years): 
 
Gender: 
Male  / Female 
(circle one) 
Handedness 
Right  /  Left 
(circle hand you write with) 
Height 
 _________ cm 
Weight 
 _________ kg 
Marital Status: 
Single / Married /  Defacto / Widowed     (circle one) 
Describe your living situation 
 Alone 
 
 With a partner/spouse  
 
 With children/grandchildren 
 
 
Where do you live?  
 Own home (house / apartment / unit) 
 
 Residential village (e.g. retirement community) 
 
 Supported accommodation (e.g. aged care facility) 
 
 Nursing home 
 
 
Are you currently living 
 Independently with no support services 
 
 Semi-independently – receive some support 
services  (e.g. meals on wheels, cleaning support, 
etc) 
 
 Fully dependent care (e.g. nursing home with 
meals and medical care provided) 
 
Prior education history 
A. _________ Total number of years at school (primary + high) 
B. _________ Total number of years of post-school formal education  
(e.g. University/College) 
C. _________ TOTAL EDUCATION YEARS (A+B) 
 
 
 
 

 
 
Have you ever fallen over? 
Yes / No 
 
If YES describe when and what occurred 
(e.g. injury) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
How fearful are you of 
falling? 
0 
Never 
1 
Rarely 
2 
A little 
3 
Moderately 
4 
Often 
5 
Always 
 
 
 
 
 
 
 
Are you currently continent? 
Urinary 
 Yes /  No 
 
Bowel 
 Yes /  No 
 
 
 
 
 
 
 
 
What type of events or entertainment have you  
 Movies 
undertaken in the last 2 months? 
 Plays / drama productions 
(tick all that apply) 
 Pub / Club 
 
 Concert / Recital 
 
 Special Performances 
 
 Dancing 
 
 Visiting Friends 
 
 Attending a sporting event 
 
 Meal at a restaurant 
 
 
 
 
 
 

 
 
How would you spend a typical day   Sleep / nothing 
(tick all that apply) 
 House work 
 
 TV 
 
 Radio 
 
 Listening to music 
 
 Walking 
 
 Gardening 
 
 Crosswords 
 
 Pet care 
 
 Socialising 
 
 Reading 
 
 Writing 
 
 Studying 
 
 Teaching 
 
 Volunteering 
 
 Paid work 
 
 Strategy games (e.g. chess, bridge, cards) 
 
 Helping friends/family 
 
 Artistry (e.g. drawing, painting, sculpture, creative 
writing, acting, etc.) 
 
 Prayer / religious activity 
 
 Playing music 
 
 Brain training games (on a computer, ipad etc) 
 
 Learning something new 
 
 Hobby or past-time 
 
 Intellectual/professional 
 
 
How often do you make an outing to see a family member,  
 Never 
friend or a group of friends? 
 Less than monthly 
 
 Monthly 
 
 Fortnightly 
 
 Weekly 
 
 Daily 
 
 
 
 
 
 
 
 

 
 
Are you currently diagnosed with a medical condition? 
  Yes / No 
 
 
IF YES 
What diagnoses have you been given? 
1. 
 
2. 
 
3. 
 
4. 
 
5. 
 
6. 
 
7. 
 
8. 
 
9. 
 
10. 
 
 
 
 
 
Are you currently diagnosed with a psychological or 
psychiatric condition? 
  Yes / No 
 
 
 
IF YES 
What diagnoses have you been given? 
1. 
 
2. 
 
3. 
 
4. 
 
5. 
 
 

 
 
 
 
 
Are you taking any prescription medication? 
Yes / No 
 
 
List all 
medications 
Medication name 
Dose (mg) 
How often  
(e.g twice daily) 
1 
 
 
 
2 
 
 
 
3 
 
 
 
4 
 
 
 
5 
 
 
 
6 
 
 
 
7 
 
 
 
8 
 
 
 
9 
 
 
 
10 
 
 
 
 
 
 
 
 
 
 
 
Are you taking any other supplements or vitamins? 
Yes / No 
 
If so what? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Do you drink alcohol? 
Yes / No 
 
 
 
 
On average, how much alcohol do you consume? 
 
 
 
Standard drinks per DAY 
 
 
 
Standard drinks per WEEK 
 
 
1 standard drink = 10 gm of alcohol = 285ml beer / 100 ml wine or champagne / 30 ml spirits  
 
 
 
 
 
 
 
 
 
Do you smoke tobacco? Yes / No 
 
 
 
 
On average, how much do you smoke PER DAY? 
 
 
 
cigarettes per DAY 
 
 
 
cigars/pipes per DAY 
 
 
 
 
 
 
 
 
 
Do you consume recreational (illicit) drugs? 
Yes / No 
 
 
What drug / how often 
1  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
2  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
3  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
4  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
5  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
6  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
 
 
 
~ Thankyou ~ 
 
 

My-AHA RCT Protocol 
 
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Appendix 6. Brief demographic questionnaire 
 
 
 

 
 
Participant Code number:  _______________ 
 
 
Study Site: 
________________________ 
Test Phase: Baseline / 6mo / 12mo / 18 mo 
 
My-AHA Demographic Questionnaire – FOLLOW-UP 
 
Demographic Information 
 
TEST PHASE :   
6 month / 12 month / 18 month        (circle one) 
Height 
 _________ cm 
Weight 
 _________ kg 
Marital Status: 
Single / Married /  Defacto / Widowed     (circle one) 
 
 
Describe your living situation 
 Alone 
 
 With a partner/spouse  
 
 With children/grandchildren 
 
 
Where do you live?  
 Own home (house / apartment / unit) 
 
 Residential village (e.g. retirement community) 
 
 Supported accommodation (e.g. aged care facility) 
 
 Nursing home 
 
 
Are you currently living 
 Independently with no support services 
 
 Semi-independently – receive some support 
services  (e.g. meals on wheels, cleaning support, 
etc) 
 
 Fully dependent care (e.g. nursing home with 
meals and medical care provided) 
 
 
 
 
 

 
 
Have you fallen over since your last assessment? 
Yes / No 
 
If YES describe when and what occurred 
(e.g. injury) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
How fearful are you of 
falling? 
0 
Never 
1 
Rarely 
2 
A little 
3 
Moderately 
4 
Often 
5 
Always 
 
 
 
 
 
 
 
Are you currently continent? 
Urinary 
 Yes /  No 
 
Bowel 
 Yes /  No 
 
 
 
 
 
 
 
 
What type of events or entertainment have you  
 Movies 
undertaken in the last 2 months? 
 Plays / drama productions 
(tick all that apply) 
 Pub / Club 
 
 Concert / Recital 
 
 Special Performances 
 
 Dancing 
 
 Visiting Friends 
 
 Attending a sporting event 
 
 Meal at a restaurant 
 
 
 
 
 
 

 
 
How would you spend a typical day   Sleep / nothing 
(tick all that apply) 
 House work 
 
 TV 
 
 Radio 
 
 Listening to music 
 
 Walking 
 
 Gardening 
 
 Crosswords 
 
 Pet care 
 
 Socialising 
 
 Reading 
 
 Writing 
 
 Studying 
 
 Teaching 
 
 Volunteering 
 
 Paid work 
 
 Strategy games (e.g. chess, bridge, cards) 
 
 Helping friends/family 
 
 Artistry (e.g. drawing, painting, sculpture, creative 
writing, acting, etc.) 
 
 Prayer / religious activity 
 
 Playing music 
 
 Brain training games (on a computer, ipad etc) 
 
 Learning something new 
 
 Hobby or past-time 
 
 Intellectual/professional 
 
 
How often do you make an outing to see a family member,  
 Never 
friend or a group of friends? 
 Less than monthly 
 
 Monthly 
 
 Fortnightly 
 
 Weekly 
 
 Daily 
 
 
 
 
 
 
 
 

 
 
Are you currently diagnosed with a medical condition? 
  Yes / No 
 
 
IF YES 
What diagnoses have you been given? 
1. 
 
2. 
 
3. 
 
4. 
 
5. 
 
6. 
 
7. 
 
8. 
 
9. 
 
10. 
 
 
 
 
 
Are you currently diagnosed with a psychological or 
psychiatric condition? 
  Yes / No 
 
 
 
IF YES 
What diagnoses have you been given? 
1. 
 
2. 
 
3. 
 
4. 
 
5. 
 
 

 
 
 
 
 
Are you taking any prescription medication? 
Yes / No 
 
 
List all 
medications 
Medication name 
Dose (mg) 
How often  
(e.g twice daily) 
1 
 
 
 
2 
 
 
 
3 
 
 
 
4 
 
 
 
5 
 
 
 
6 
 
 
 
7 
 
 
 
8 
 
 
 
9 
 
 
 
10 
 
 
 
 
 
 
 
 
 
 
 
Are you taking any other supplements or vitamins? 
Yes / No 
 
If so what? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Do you drink alcohol? 
Yes / No 
 
 
 
 
On average, how much alcohol do you consume? 
 
 
 
Standard drinks per DAY 
 
 
 
Standard drinks per WEEK 
 
 
1 standard drink = 10 gm of alcohol = 285ml beer / 100 ml wine or champagne / 30 ml spirits  
 
 
 
 
 
 
 
 
 
Do you smoke tobacco? Yes / No 
 
 
 
 
On average, how much do you smoke PER DAY? 
 
 
 
cigarettes per DAY 
 
 
 
cigars/pipes per DAY 
 
 
 
 
 
 
 
 
 
Do you consume recreational (illicit) drugs? 
Yes / No 
 
 
What drug / how often 
1  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
2  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
3  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
4  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
5  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
6  __________________ 
Daily / Weekly / Fortnightly / Monthly 
 
 
 
 
~ Thankyou ~ 
 
 

My-AHA RCT Protocol 
 
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Appendix 7. WHOQoL-OLD 
 
 
 

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Appendix 8. Lawton-Brody IADL Scale 
 
 
 

 
 LAWTON-BRODY 
 
INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.) 
 
PARTICIPANT CODE:  _______________ 
STUDY SITE: 
____________________________________ 
TEST PHASE: 
Baseline / 6 mo / 12 mo / 18 mo    (circle one) 
 
Scoring: For each category, circle the item description that most closely resembles the client’s highest 
functional level (either 0 or 1). 
 
A. Ability to Use Telephone 
 
E. Laundry 
 
1. Operates telephone on own initiative-looks up 
and dials numbers, etc. 
2. Dials a few well-known numbers 
3. Answers telephone but does not dial 
4. Does not use telephone at all 
1 
 
1 
1 
0 
1. Does personal laundry completely 
2. Launders small items-rinses stockings, etc. 
3. All laundry must be done by others 
1 
1 
0 
B. Shopping 
 
F. Mode of Transportation 
 
1. Takes care of all shopping needs independently 
2. Shops independently for small purchases 
3. Needs to be accompanied on any shopping trip 
4. Completely unable to shop 
1 
0 
0 
0 
 
1. Travels independently on public 
transportation or drives own car 
2. Arranges own travel via taxi, but does not 
otherwise use public transportation 
3. Travels on public transportation when 
accompanied by another 
4. Travel limited to taxi or automobile with 
assistance of another 
5. Does not travel at all 
1 
 
1 
 
1 
 
0 
 
0 
C. Food Preparation 
 
G. Responsibility for Own Medications 
 
1. Plans, prepares and serves adequate meals 
independently 
2. Prepares adequate meals if supplied with 
ingredients 
3. Heats, serves and prepares meals, or prepares 
meals, or prepares meals but does not maintain 
adequate diet 
4. Needs to have meals prepared and served 
1 
 
0 
 
0 
 
 
0 
 
1. Is responsible for taking medication in 
correct dosages at correct time 
2. Takes responsibility if medication is 
prepared in advance in separate dosage 
3. Is not capable of dispensing own 
medication 
 
1 
 
0 
 
0 
D. Housekeeping 
 
H. Ability to Handle Finances 
 
1. Maintains house alone or with occasional 
assistance (e.g. "heavy work domestic help") 
2. Performs light daily tasks such as dish washing, 
bed making 
3. Performs light daily tasks but cannot maintain 
acceptable level of cleanliness 
4. Needs help with all home maintenance tasks 
5. Does not participate in any housekeeping tasks 
1 
 
1 
 
1 
 
1 
0 
1. Manages financial matters independently 
(budgets, writes checks, pays rent, bills, 
goes to bank), collects and keeps track of 
income 
2. Manages day-to-day purchases, but needs 
help with banking, major purchases, etc. 
3. Incapable of handling money 
1 
 
 
 
1 
 
0 
 
Score 
 
Score 
 
 
 
Total score 
 
A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid 
potential gender bias. 

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Appendix 9. CES-D 2 item questionnaire 
 
 
 

Participant Code number:  _______________ 
 
 
Study Site: 
________________________ 
Test Phase: Baseline / 6mo / 12mo / 18 mo 
 
 
 
CES-D 
 
 
 
 
Statement 
Rarely or none of the 
time 
(less than 1 day) 
Some or a little of 
the time  
(1-2 days) 
Occasionally or a 
moderate amount of 
time  
(3-4 days) 
Most or all of the 
time  
(5-7 days) 
 
1. How often in the past week have you felt that everything 
you did was an effort? 
1 
2 
3 
4 
 
2. How often in the past week have you felt that you could not 
get going? 
1 
2 
3 
4 
 
Total Score  
 
 
 
 

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Appendix 10. Short Physical Performance Battery (SPPB) 
 

 
Page 119 
 
 
 

 
Page 120 
 
 
 

 
Page 121 
 
 
 

 
Page 122 
 
 
 

 
Page 123 
 
 
 

 
Page 124 
 
 
 

 
Page 125 
 

 
Page 126 
 
 

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Appendix 11. IPAQ – Short Form 
 

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Appendix 12. Activities specific Balance Confidence (ABC) Scale 
 

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Appendix 13. Physical Activity Enjoyment Scale (PACES) 
 
 
 

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Appendix 14. Mini Mental State Examination (MMSE) 
 

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Appendix 15. Hopkins Verbal Learning Test (HVLT) 
 

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Appendix 16. WMS-III Spatial Span (SSP) test 
 

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Appendix 17. Trail Making Test (TMT) 
 

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Appendix 18. 24-item Victoria Version Stroop Test 
 

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Appendix 19. WAIS-III Digit Symbol Coding (DSC) test 
 

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Appendix 20. Hospital Anxiety Depression Scale (HADS) 
 

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Appendix 21. Lubben Social Network Scale – Revised (LSNS-R) 
 

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Appendix 22. UCLA Loneliness Scale 
 

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Appendix 23. Self-MNA scale 
 
 

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Appendix 24. Computer Literacy Scale (CLS) 
 

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Appendix 25. Evaluation of Usability Scale (SUS) 

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Appendix 26. DART Questionnaire 
 

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Appendix 27. User Experience Questionnaire (UEQ) 
 

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