Feasibility Study to Test the Implementation of Health Promotion Advice (Exercise and Protein Intake) for Older People Attending a Community Mental Health Service.
Conditions: Mental Health Issue, Frailty
Sponsor: University College Cork

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September 25 2023  
Study Title: Feasibility study to test the implementation of Health promotion advice 
(exercise and protein intake) for older people attending a community mental health 
service 
 
Short title: Brief health promotion intervention for older people in mental health services  
Date  September 25 2023 
NCT number (not available yet) 
 
 

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September 25 2023  
 
Background  
Frailty is an age-related syndrome and describes the condition of older people’s increased 
risk of adverse health outcomes, such as falls, institutionalization, hospitalization, 
disability and death.  From The Irish Longitudinal study on Aging (TILDA) the prevalence of 
frailty in community dwelling adults aged 50 years and over in Ireland was 12.7% and the 
prevalence of pre-frailty was 31%. In people aged 65 year and over, the prevalence 
increased to 21.5% and 40% for pre-frailty. 
In older people living with enduring or new onset mental health conditions, a recent 
systematic review suggested the prevalence of frailty in older people living with severe 
mental illness between 10.2 and 89.7% and was high in comparison to the general 
population (Pearson et al 2022).  individuals with a mental disorder had greater all-cause 
mortality hazards than the comparison group without mental disorders. The highest hazard 
ratio (3.65, 95% CI 2.40-5.54) was observed among individuals with bipolar disorder and 
frailty, relative to non-frail individuals without mental disorders. 
 Mental health is defined as a “state of well-being in which the individual realises his or her 
own abilities, can cope with the normal stresses of life, can work productively and fruitfully, 
and is able to make a contribution to his or her community” (WHO, 2001). Mental illness is 
described as the loss of mental health due to a mental disorder. The Mental Health Act 2001 
defines mental illness as ‘‘a state of mind of a person which affects the person’s thinking, 
perceiving, emotion or judgment and which seriously impairs the mental function of the 
person to the extent that he or she requires care or medical treatment in his or her own 
interest or in the interest of other persons” (Government of Ireland 2001, pg.10). The Older 
Adult mental health service cares for and provides treatment for new onset functional mental 
illness and dementia with complex behaviours for persons over the age of 65 years.   
TILDA found frailty to have a bi directional relationship with mental health and older adults. 
People living with frailty are more likely to experience decline in mental health, lowering 
cognitive function and an increase in depressive symptoms. While people who live with 
enduring mental health may experience accelerated ageing and frailty due to mental distress 
and prolonged medication use or substance abuse.  
There is a strong evidence base for reversal of frailty in the general population (Reference 
systematic reviews), interventions focus on exercise with or without protein based nutrition. 
However, there is very few studies that have translated this research to older peoples living 
with severe mental illness.  
A recent RCT undertaken in Irish GP practices identified the acceptability and effectiveness 
of a low intensity intervention combining brief (<10 mins) advice on exercise and nutrition as 
with supporting information leaflets were acceptable to older people and helped to improve 
functional performance (Travers et al 2020). (Appendix 1 exercise and nutrition leaflets ). 
In mental health consultations, advice on exercise and nutrition is often provided  mental 
well-being benefits but it is not discussed in relation to building resilience and preventing 
frailty (Traver et al In press). 

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September 25 2023  
In this study we aim to test the acceptability and feasibility of replicating the above 
intervention for older patients attending MH consultations with the candidate ANP [AK].   
 
Aim 
The aim of this study is to test the delivery of brief health promotion advice with supporting 
information leaflets as part of standard clinical consultation for older people attending a 
community mental health service.  
 
Objectives: The main objectives are to;  
(a) to screen MH patients  for frailty using validated tools the clinical frailty scale and 
SCAR-F   
(b) to test the feasibility of patient recruitment and data collection in the target population 
(c) determine the prevalence of frailty in older adults living with a mental health condition 
within an outpatient MH service 
(d) examine the acceptability of the brief health promotion advice and information leaflets 
as part of MH consultation  
(e) examine self-reported adherence to the exercise and nutrition advice at 1 and 3-
month follow-up 
(f) Repeat frailty screening and overall physical and mental health at three month follow-
up  
 
Target Population  
 
The target population is older adults attending mental health service aged 65 years and 
older. Age 65 years is the age for referral to the older adult mental health services. The 
Older adult mental health services provide care and treatment for people aged over 65’s who 
develop new onset functional mental illness such as depression, severe anxiety  or those 
with a diagnosis of dementia with behavioral and psychological problems requiring specialist 
intervention and care.  
Patients with stable mental health conditions (during a recovery phase) will be identified form 
community mental health clinics and ANP community case load 
Sample size 
We aim to recruit 15-20 patients to test the feasibility of the intervention in this population.  
 
 
Inclusion criteria  
For the purpose of this study service users eligible for the study are:  
(a) Aged 65 years and older 

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September 25 2023  
(b) Cognitive capacity to provide informed consent 
(c) Attending Older adult mental health services  
(d) MH team deem client stable and able to participate in intervention  
(e) Patient independently mobile and living in the community (may use a walk 
aid)(Clinical frailty Scale ≤5) 
Exclusion Criteria 
 
For the purpose of this study 
(a) Service users with moderate advanced dementia will be excluded as the intervention 
is unsupervised.   
(b) Patents who cannot provide informed consent  
(c) Patients that cannot understand English or require a translator  
(d) Patients experience acute mental health crisis  
(e) Patients with significant restricted mobility, using Zimmer frame inside or outside their 
house (CFS≥5) 
 
 
 
Study Design 
 
The study uses a one group pretest –posttest intervention design with patient survey at 
baseline, 1 month and 3 month follow-up. The project is undertaken over 12 months. Once 
ethical approval is obtained, patient recruitment and baseline data is collected and the 
intervention delivered: in March – June 2023, 1 month follow-up April to July and three 
month follow-up August to October 2023.   
Intervention components 
The intervention is delivered by the candidate ANP who is an experienced mental health 
nurse and is skilled in using motivational interviewing principles to support behaviour 
change. A normal part of the role is the provision of  general health promotion advice for 
patients in clinics and their home.  This aligns with the HSE policy on Making Every Contact 
Count (https://www.hse.ie/eng/about/who/healthwellbeing/making-every-contact-count/). 
 
• 
Deliver brief Health Promotion advice on exercise and protein nutrition for muscle 
health to promote resilience and reduce risk of frailty  
• 
Provide patients with information leaflets and clarify expectations for frequency of 
exercise (Appendix). The exercise and nutrition advise leaflets are used with 
permission of Travers et al 2022. Both leaflets were deigned based on extensive 
public patient involvement with older patients, physiotherapist and dietician. The 
exercises are low risk (use a chair for balance support, sit to stand exercises). 
Patients with impaired mobility, using Zimmer frame are excluded from study.  
• 
One-month follow-up is undertaken via telephone (or face-to-face if visit scheduled 
as part of routine care). The one-month follow-up is to encourage adherence to 

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September 25 2023  
exercise and nutrition advice and examine adherence and feasibility of undertaking 
exercise and following diet advice. 
Data collection 
 The ANP completes the structured questionnaire with the patient in the MH clinic or patient 
home during routine clinical consultations. The one-month and three month follow-up via 
telephone or in the OPD clinic/persons’ home as part of normal schedule of visits. No extra 
clinic or home visits are planned as part of the study. 
The structured questionnaire used in this study has been developed by an expert group of 
geriatricians, and old age psychiatry and includes validated measures of frailty (see below) 
This study tests the user acceptability of the intervention and the recruitment and data 
collection approach. 
Ethical approval was obtained from Clinical Research Ethics Committee of the Cork 
Teaching Hospitals (CREC) 
Obtaining Consent  
 
Participants provide written consent to the study. the ANP liaises with the Mental Health 
team to identify eligible patients and ensure the team are happy for the service user to be 
approached about the study.  
Service Users receive an introduction letter and a copy of the patient information sheet 
informing them of the study and advising that they may be  asked to participate in the study 
at their next outpatient appointment or home visit. The patient meets the data collector who 
explains the study, answer any questions and obtains written consent.  
Participants are given the right to withdraw from participation should they wish to, as well as 
to opt out of answering questions. Participants have a right to withdraw without explanation. 
Patients provide permission to collect identifying information to allow follow-up. As soon as 
follow-up is complete, all identifying information is removed from the dataset so the data 
becomes de-identified and the participant is allocated a study ID. 
Data Collection 
Following consent the patient participates in face-to-face interviews with the ANP where a 
structured questionnaire will be completed (there are no qualitative interviews). The 
questionnaire has been developed by an expert group of geriatricians, and old age 
psychiatry.  
Data collection  includes socio-demographic details, MH diagnosis, co-morbidities,  
Outcomes:  
Sarcopenia: The SARC-F (tool title not an abbreviation) is a screening tool for sarcopenia 
((Malmstrom et al 2013). SARC‐F comprises five components using self-report on: strength, 
assistance walking, rise from a chair, climb stairs, and falls.  SARC‐F scale scores range 
from 0 to 10 (i.e. 0–2 points for each component; 0 = best to 10 = worst) and are 
dichotomized to represent symptomatic (4+) vs. healthy (0–3) status (Malmstrom et al 2016).  

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Frailty: Clinical Frailty Scale (CSF) is a judgement-based frailty tool that evaluates specific 
domains including comorbidity, function, and cognition to generate a frailty score ranging 
from 1 (very fit) to 9 (terminally ill), a higher score indicates poorer physical and cognitive 
function  (Rockwood et al 2005, Church 2020).  
The Global Physical Health Scale v1.2 is a four-item validated general health questionnaire 
Riley et al 2010, Hays et al 2015). Four items are used to assess global physical health. 
Three items (rate your physical health, everyday activities , rate your fatigue ) of these are 
administered using five-category response scales. Higher scores indicated better health. 
One item (rating of pain on average) uses a response scale of 0–10 that is recoded to five 
categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5), the scale is then reverse coded, i.e. 0 
(no pain)= 5). Overall scores range from 5 to 20 indicating best possible physical health 
(PROMIS 2021)  
Mental health: Bespoke mental health items. Two items (rate your overall mental health, rate 
your mood (sense of well-being) over past seven days was rated on a 5 point scale 
(excellent =5; very poor =1). Items are presented separately, scores range from 1 to 5, 
higher score indicates better mental health. 
Exercise: Two items from Yale Physical Assessment Scale (vigorous exercise frequency and 
duration over past 7 days, and Walking for exercise frequency and duration over past 7 days 
((De Abajo et al., 2001). Frequency was rated on a 4 point scale (not at all=0; 1-2 times=1, 
3-4 times=2 or  >4 times=3) Duration (0=not applicable, 1=10-30 mins, 2=31-60 mins, 3> 60 
mins. Scores are calculated by multiplying Frequency score X Duration score (no weight was 
applied). Higher scores indicate more activity. Items were not combined for an overall 
exercise score.   
Post intervention, we added an additional question specific to the exercises on the 
information leaflet 
In the past week (7 days) have you completed the exercises on the information leaflet 
Frequency (None=0, 1 day=1, 2 days=2; 3 days=3, 4days=4, 5 days=5); X Duration (none 
=0; 10 mins=1, 11-20 mins=2 , 21-30 mins=3, >30 mins=4). Higher values indicate greater 
exercise intensity (min score 0 to 20). 
Nutrition: Simplified nutritional appetite questionnaire (SNAQ) is a four item scale (rate 
appetite, When I eat I feel full, food tastes, normally I eat)  are rated on a five point scale (1 
to 5). Total possible score range from 5 to 20, higher scores indicate better appetite. SNAQ 
score 14 indicates significant risk of at least 5% weight loss within six months (Kruizenga et 
al., 2005). 
Protein intake: Patients self-reported the number of protein portions eaten in the previous 
day: Protein was categorised as: meat/fish; milk/diary; eggs/cheese; vegetable protein 
The one-month questionnaire focused on acceptability of intervention and ease of use.  
Patients are also be asked to give qualitative feedback on the intervention. 
 

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The 3-month questionnaire repeated the baseline measures and adherence questions. 
Implementation outcomes:  
Acceptability (Bespoke item)  
One item measures acceptability: The exercise and nutrition advice was acceptable to me 
(made sense) rated on a 5 point Likert scale (1=strongly disagree to 5 strongly agree) 
Ease of Use (Bespoke item)  
One item measured Ease of Use ‘ To what extent was it easy to incorporate the exercise an 
nutrition advice into your daily routine rated on a five point Likert scale (1=very difficult  to 5 
very easy) 
Recommend to others (bespoke item) 
The final item sought participants opinion on ‘recommending the intervention to others. ‘In 
your opinion, should we continue to offer this advice and information leaflets to other people 
attending our service? With three response options Yes/No/ Don’t know 
 
A study log is maintained recording the number of eligible patients invited to participate, the 
number of patients who refused, reasons for refusal, number of patients who consented, 
number of patients who completed 1-month and 3-month follow-up.  
Data management  
Data is collected using a paper questionnaire. The data collector is not blinded to the study 
intervention.  
Each participant is allocated a study ID that links the study register maintained by clinical site 
to the questionnaire data. The patient ID file will be stored separately from the Research 
data with a Participant ID used to link the two files. The excel sheets are stored in a 
password protected PC in the HSE in a locked office facility. Paper questionnaires are stored 
in a locked filling cabinet on the clinical site in the HSE facility 
Only de-identified data using a Study ID is shared with UCC PI (CN) using encrypted and 
password protected file. As soon as the 3-month follow-up is completed (within 6 months of 
the study start date), the Study Register linking identifiable data with the questionnaire data 
is destroyed at the clinical site. 
Data is analysed using SPSS software V27, the database is stored in a UCC  icloud (one 
drive). Once data is entered and verified, all paper questionnaires and study register are 
destroyed. Only the study team have access to the data.  
 
Analysis 
Data analysis uses descriptive statistics.  Categorical data is presented as proportions and 
percentages, continuous data as medians inter quartile ranges. Non-parametric paired 
statistics is used to compare the pre and post data, however sample size is too small for a 
comprehensive analysis.  

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September 25 2023  
 
 
Patient Safety Protocol 
The participants are  part of the mental health services, the interviews are undertaken  by an 
experienced cANP, who has worked as a community mental health nurse for > 15 years. If 
there are signs of patient deterioration, the patients is managed per standard mental health 
protocols. The ANP discontinues study data collection to focus on the person’s clinical 
management. Based on clinical presentation the person may be referred for urgent review to 
OPD clinic, or admission to acute MH unit.  
 

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September 25 2023  
 
Church, S., Rogers, E., Rockwood, K. et al. A scoping review of the Clinical Frailty 
Scale. BMC Geriatr 20, 393 (2020). https://doi.org/10.1186/s12877-020-01801-7 
Ida S, Kaneko R, Murata K. SARC-F for Screening of Sarcopenia Among Older Adults: A 
Meta-analysis of Screening Test Accuracy. J Am Med Dir Assoc. 2018 Aug;19(8):685-689. 
doi: 10.1016/j.jamda.2018.04.001. Epub 2018 May 31. PMID: 29778639. 
Pearson E, Siskind D, Hubbard RE, Gordon EH, Coulson EJ, Warren N. Frailty and severe 
mental illness: A systematic review and narrative synthesis. J Psychiatr Res. 2022 
Mar;147:166-175. doi: 10.1016/j.jpsychires.2022.01.014. Epub 2022 Jan 8. PMID: 
35051715. 
Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. 
J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 
Jun 25. PMID: 23810110. 
Malmstrom TK, Miller DK, Simonsick EM, Ferrucci L, Morley JE. SARC-F: a symptom score 
to predict persons with sarcopenia at risk for poor functional outcomes. J Cachexia 
Sarcopenia Muscle. 2016 Mar;7(1):28-36. doi: 10.1002/jcsm.12048. Epub 2015 Jul 7. PMID: 
27066316; PMCID: PMC4799853. 
Mutz J, Choudhury U, Zhao J, Dregan A. Frailty in individuals with depression, bipolar 
disorder and anxiety disorders: longitudinal analyses of all-cause mortality. BMC Med. 2022 
Aug 30;20(1):274. doi: 10.1186/s12916-022-02474-2. PMID: 36038880; PMCID: 
PMC9425946. 
Hays RD, Spritzer KL, Thompson WW, Cella D. U.S. General Population Estimate for 
"Excellent" to "Poor" Self-Rated Health Item. J Gen Intern Med. 2015 Oct;30(10):1511-6. doi: 
10.1007/s11606-015-3290-x. Epub 2015 Apr 2. PMID: 25832617; PMCID: PMC4579204. 
PROMIS (2021) GLOBAL HEALTH SCORING. 
MANUALhttps://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/P
ROMIS_Global_Health_Scoring_Manual.pdf 
Riley, C D., , W., Stone, A., Rothrock, N., Reeve, B., Yount, S., ... & PROMIS Cooperative 
Group. (2010). The Patient-Reported Outcomes Measurement Information System 
(PROMIS) developed and tested its first wave of adult self-reported health outcome item 
banks: 2005–2008. Journal of clinical epidemiology, 63(11), 1179-1194. 
Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A 
global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 
30;173(5):489-95. doi: 10.1503/cmaj.050051. PMID: 16129869; PMCID: PMC1188185. 
Travers J, Romero-Ortuno R, Cooney MT. Testing the feasibility of a primary-care exercise 
intervention to prevent and reverse early frailty and build resilience in community-dwelling 
older adults. EClinicalMedicine. 2022 Mar 22;46:101355. doi: 10.1016/j.eclinm.2022.101355. 
PMID: 35340628; PMCID: PMC8943408. 

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Travers J, Romero-Ortuno R, Power D et al. Protocol for a randomised controlled trial of a 
primary care intervention to Reverse Frailty and Enhance Resilience through Exercise and 
dietary protein Education in community-dwelling adults aged 65 and over [version 2; peer 
review: 2 approved]. HRB Open Res 2021, 3:91 
(https://doi.org/10.12688/hrbopenres.13188.2) 
 
 
Appendix patient information leaflets  
 
 
 
 
 

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September 25 2023  
 
Feasibility study to test the implementation of health promotion advice 
(exercise and protein intake) for older people attending a community mental 
health service. 
Participant information leaflet 
 
Principal Investigator Name: Professor Corina Naughton 
Principal Investigator Role: Professor of Nursing in Older Person Health Care,   
University College Cork, Telephone number 021 490 1551 
 
About the project: 
This is a research study being undertaken as part of an MSc. Dissertation through 
the School of Nursing and Midwifery, University College Cork. 
As we age, we experience a decrease in muscle strength, energy and ability to 
undertake some activities (shopping, cooking, or housework). Frailty is a term used 
to describe this decrease in energy and muscle strength. We know that participating 
in regular exercise and eating protein (chicken, meat, fish, nuts) can help muscle to 
stay strong. 
 
What does the study involve? 
During your normal routine clinic or home visit, one of your medical team [ Aoife 
Kelly] will provide you with a brief (<10 minutes) health advice on exercise and how 
to increase protein in your regular diet. You will also receive two information leaflets 
to take away.  While at home, we would like you to carry out the exercises at your 
own pace and to gradually increase protein in your diet. 
 
We want to see what (if any) effect the advice (on exercise and protein) has on your 
regular habits and how you feel about your physical and mental health. 
 
we would like to collect some information from you at the start of the project (before 
the advice), 1 month and 3- months after receiving the advice leaflets. We will collect 
the information: 
1) In a face-to face interview, the researcher ( A Kelly) will ask you questions and record 
the information in a structured paper questionnaire. The questions will be about your 
health, physical activity, level of exercise and appetite. The interview will take about 
10 minutes. There are no right or wrong answers and we would like you to be as 
frank as possible.  
2) We would like your permission to collect information from your medical record about 
your diagnosis and any other physical health conditions. 
3) In one months’ time (4 weeks), Aoife will ring you to see how you are doing with the 
exercise and protein advice and if you have any questions, the phone call will take 5-
10 minutes.  
4) In three months’ time (12 weeks), Aoife, will ring you again and ask similar questions 
about how you are feeling, your level of physical activity, appetite and if you were 
able to carry out the exercises. The interview will take about 10 minutes. If you are 
due back to clinic, we can do the interview with you at the clinic.  
 
 

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September 25 2023  
Why are we contacting you? 
We are inviting all service users aged 65 years and older attending the older adult 
Mental Health Services in South Lee catchment area Cork Kerry community 
Healthcare to participate in this study.  
 
 Do I have to take part? 
No, you do not have to participate in the study. If you decide not to participate, it will 
have no impact on any aspect of your care in any way. You are also free to change 
your mind and withdraw from the study at any time during the interview or follow-up. 
 
What will my involvement require? 
If you agree to take part, we will ask you to sign a consent form so we can use your 
data (information) as part of the study. You will not be identified by name in any of 
the research data. A researcher ( Ms. A Kelly) will ask you questions and provide the 
Health advice and information leaflets during your normal outpatient clinic or home 
visit. We will fit the research study around your schedule, so there is minimal 
interruption.  
 
What are the possible disadvantages or risks of taking part? 
There is minimal risk associated with the study. If you become tired at any stage during 
the interview, you can ask the researcher to stop. The exercises have been designed 
to be as low risk as possible for older people, however with any activity there is a small 
risk that you could fall or hurt yourself. We ask people to only go at your own pace and 
to build up the exercise slowly. There is minimal risk in eating recommended amounts 
of protein as part of a balanced diet, but if you do not regularly eat protein then it is 
useful to build up slowly.  
 
What are the possible benefits of taking part? 
There may be no direct benefit for you in taking part in this study. The study will not 
change your current treatment plan. You may notice a positive change in the amount 
of exercise you can do and your fitness. The study will tell us if this type of activity is 
useful for older people with mental health conditions. We anticipate that this 
information will help guide treatment and care plans for patients identified as frail or at 
risk of frailty 
 
Data Protection Notice 
 
We treat your privacy seriously. Any personal data which you provide to the researcher 
will be treated with the highest standards of security and confidentiality, in accordance 
with Irish and European Data Protection legislation. This notice sets out details of the 
information that we collect, how we process it and who we share it with. It also explains 
your rights under data protection law in relation to our processing of your data. 
 
 
Who we are 
Throughout this notice, ‘’we’’, ‘’us’’, and ‘’our’’ refers to University College Cork, as 
study sponsor. For more information about us please refer tour website:www.ucc.ie 

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September 25 2023  
 
How we will use your personal data 
By participating in the study and performing the study exercises, information from you (also 
called “personal data”) will be collected for the study purposes mentioned in the Patient 
information leaflet above. This personal data includes, for example: 
−      Your name and telephone number so we can contact you at 1 and 3 months follow-up. 
Once the data collection is finished, we will delete your name and number from the research 
data, so nobody will be able to identify you from the study.  
Your personal data (name and telephone number) will not leave the clinical site, only 
members of your mental health team will have access to this information. 
 
We will also collect information on your age, gender, health conditions, physical activity and 
appetite. Personal data collected at any time during the study will be kept strictly confidential.  
To ensure confidentiality, the data generated during the study is coded with a number that 
will identify you in the study. Any information that leaves the clinical site will be labelled with 
your code instead of your name. Every person that has access to your uncoded data is 
subject to professional secrecy and confidentiality. We will not remove any of your uncoded 
personal data from the clinic e.g. your name or telephone number. During the course of the 
study, if you disclose information that we feel has implication for your safety or the safety of 
other people, we will have to relay this information to a member of your mental health team. 
Before we do this, we will discuss the issue with you.  
 
Who will access my personal data? 
Your coded data will only be accessible to the study investigator and study staff. Results of 
the study will be provided to the Clinical Research Ethics Committee of the Cork Teaching 
Hospitals (CREC) in compliance with national and international regulations on clinical 
studies. 
 
The purpose and legal basis for collecting your data 
Any personal data you provide to us during the course of this study will be processed fairly 
and lawfully. Signing the Informed Consent Form means that your personal data will be used 
for the purposes outlined in the Patient information leaflet (PIL). 
Personal data collected during this study and the results of the study may be presented for 
scientific purposes. However, you will never be identified individually during these 
presentations. Your identity will not be revealed in any reports or publications. 
The clinical site and the investigator will use your personal data within the scope defined 
above. 

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September 25 2023  
The General Data Protection Regulation allows us to process your data because you have 
provided your consent. You are entitled to withdraw your consent at any time. 
  
How long we will keep your data 
The personal data (name and telephone number) in the study register will be kept for six 
months by your clinical team and will not be transferred to any third party. Once the data 
entry is completed we will delete your name and telephone number from our research data. 
The remaining research data be stored for 10 years in line with the UCC Code of Research 
Conduct V2.4 dated 14 SEP 2021. Thereafter, they may be stored for a further period of time 
for legal reasons (e.g. revised retention obligations), or more if required by law. 
 
Your rights 
You have various rights under data protection law, subject to certain exemptions, in connection 
with our processing of your personal data, including the right: 
• 
to find out if we use your personal data, access your personal data and receive copies 
of your personal data; 
• 
to have inaccurate/incomplete information corrected and updated; 
• 
in certain circumstances, to have your details deleted from systems that we use to 
process your personal data or have the use of your personal data restricted in certain 
ways; 
• 
to object to certain processing of your data by UCC; 
• 
to exercise your right to data portability where applicable (i.e. obtain a copy of your 
personal data in a commonly used electronic form; 
• 
to withdraw your consent to the processing of your data at any time without giving a 
reason by notifying your decision to the investigator. This will not affect the lawfulness 
of processing data about you based on your consent before the withdrawal. If you 
withdraw your consent for data processing, your participation in the study stops and 
no further data will be collected from you. Your study physician will present you the 
options you have concerning your personal data. 
• 
Along with study withdrawal, you have the right to request the deletion of data about 
you if your data are no longer necessary for the purposes of processing or there is no 
other legal ground for their further processing. 
If you wish to exercise any of these rights, please address your request to the study physician 
or the Information Compliance Manager, University College Cork (details below). 
Questions or Complaints 
If you have any queries in relation to this study please contact Professor Corina Naughton 
(details below). If you have any complaints in connection with our processing of your 
personal data, you can contact UCC’s Information Compliance Manager: Information 
Compliance Manager, Office of Corporate & Legal Affairs, University College Cork, 
Western Road, Cork E: foi@ucc.ie Tel: +353 21 4903949 

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You also have the right to lodge a complaint with the Data Protection Commission if you are 
unhappy with our processing of your personal data. Details of how to lodge a complaint can 
be found on the Data Protection Commission’s website (www.dataprotection.ie), or by 
telephoning 1890 252 231. 
What if there is another concern? 
Any complaint or concern about any aspect of the way you have been treated during the 
course of the study will be addressed; please contact Professor Josephine Hegarty,  Head of 
School of Nursing and Midwifery, University College Cork  (J.Hegarty@ucc.ie.ie) 
Full contact details of Principal Investigator: 
Professor Corina Naughton, 
Professor of Nursing in Older Person Health Care,  University College Cork 
Telephone number 021 490 1551 corina.naughton@ucc.ie 
Who has reviewed the project? 
This study was submitted to Cork Research Ethics Committee (CREC). 
     Thank you for taking the time to read this Information Sheet. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Feasibility study to test the implementation of health promotion advice (exercise and 
protein intake) for older people attending a community mental health service 
Consent Form for Participants 
 Principal Investigator: Professor Corina Naughton, Professor of Nursing in Older Person 
Health Care, University College Cork, School of Nursing and Midwifery, Brookfield 
Campus, Cork.  Email: corina.naughton@ucc.ie   
Thank you for considering taking part in this research. The person organising the research 
must explain the project to you before you agree to take part. If you have any questions 
arising from the Information Sheet, please ask the researcher before you decide whether to 
join in. 
 
 
  
I confirm that I understand that by ticking/initialling each box I am consenting to this 
element of the study. I understand that it will be assumed that unticked/initialled boxes 
mean that I DO NOT consent to that part of the study. I understand that by not giving 
consent for any one element I may be deemed ineligible for the study. 
 
 
 
 
 
1. I confirm that I have read and understood the information sheet dated [v1 .2] for the 
above study. I have had the opportunity to consider the information and asked questions 
which have been answered satisfactorily. 
 
2. I understand that my participation is voluntary and that I am free to withdraw at any time 
without giving any reason.   
 
3.  I understand that information will be handled in accordance with the terms of the Data 
Protection Act 2018 and as outlined in the Data Protection Notice in the Patient 
Information Leaflet.  
 
4. I understand that my information may be subject to review by responsible individuals 
from the ethics committee or UCC for monitoring and audit purposes. 
 
5. I understand that confidentiality and anonymity will be maintained and it will not be 
possible to identify me in any publications. However, I understand that in the event of 
significant risk to myself or others confidentiality may have to be breached    
 
6. I agree that the research team may store and use my de-identified data for future research 
for up to ten years. Data would not be identifiable in any report.  
 
 
7. I understand that the information I have submitted will be published as a report and in 
academic journal.  
 
 

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September 25 2023  
8. I understand that I must not take part if I fall under the exclusion criteria as detailed in the 
information sheet and explained to me by the researcher.  
 
 
9. I have informed the researcher of any other research in which I am currently involved or 
have been involved in during the past 12 months 
 
STORAGE AND FUTURE USE OF INFORMATION 
 
 
I give permission for material/data to be stored for possible future 
research related to the current study with my future consent and only if 
the research is approved by a Research Ethics committee 
Yes  
No  
 
 
 
__________________               __________________              _________________ 
Name of Participant                 Date 
 
 
    Signature 
 
 
 
__________________               __________________              _________________ 
Name of Researcher