Feasibility and Effectiveness of Frailty Screening and Management Programs Implemented in Different Clinical Settings (FRAILCLINIC)
Phase: NA
Conditions: Frailty Syndrome
Sponsor: Hospital Universitario Getafe

 
 
1 
FRAILCLINIC 
Study Title: 
FEASIBILITY AND EFFECTIVENESS OF THE 
IMPLEMENTATION OF PROGRAMS TO SCREEN 
AND MANAGE FRAIL OLDER PATIENTS IN 
DIFERRENT CLINICAL SETTINGS 
INTERVENTIONAL PHASE 
 
Protocol identifying number: 20131208 
 
Confidentiality Statement: 
This document contains confidential information that must not be 
disclosed to anyone other than the Sponsor, the Investigator Team, 
Regulatory Authorities, and members of the Ethics Committee.   
 
 
Sponsor: FUNDACIÓN PARA INVESTIGACION BIOMÉDICA DEL 
HOSPITAL UNIVERSITARIO DE GETAFE 
 
 
Project Leader: Prof. Leocadio Rodríguez Mañas 
Medical monitor: Prof. Leocadio Rodríguez Mañas. 
Email: leocadio.rodriguez@salud.madrid.org 
Fax: 0034 916247305 
Study promoted by DG SANCO “HEALTH-2013 

 
 
2 
TABLE OF CONTENTS 
1 
ABREVIATIONS ................................................................................................................. 5 
2 
INTRODUCTION ................................................................................................................ 6 
2.1 
BACKGROUND INFORMATION: ........................................................................ 6 
2.2 
RATIONALE OR JUSTIFICATION ......................................................................... 7 
3 
OBJECTIVES ........................................................................................................................ 9 
3.1 
PRIMARY OBJECTIVE: ........................................................................................ 9 
3.2 
SECONDARY OBJECTIVES: ................................................................................. 9 
4 
OUTCOMES ....................................................................................................................... 11 
4.1 
PRIMARY OUTCOMES: .................................................................................... 11 
4.2 
SECONDARY OUTCOMES: ............................................................................... 11 
5 
STUDY DESIGN ................................................................................................................ 13 
6 
ELEGIBILITY ..................................................................................................................... 15 
6.1 INCLUSION CRITERIA: ........................................................................................... 15 
6.2     EXCLUSION CRITERIA: ....................................................................................... 15 
7 
RECRUITMENT ................................................................................................................ 16 
7.1 
INFORMED CONSENT AND ELEGIBILITY CRITERIA .......................................... 16 
7.2 
RANDOMIZATION ........................................................................................... 17 
7.3 
SAMPLE SIZE ................................................................................................... 17 
7.4 
STATISTICAL ANALYSIS .................................................................................... 18 
8 
INTERVENTION AND CONTROL ................................................................................. 20 
8.1 
CONTROL GROUP ........................................................................................... 20 
8.2 
INTERVENTION GROUP ................................................................................... 20 
9 
ASSESMENTS DURING THE STUDY ........................................................................... 21 
9.1 
BASELINE EVALUATION (visit 0= FIRST VISIT) ................................................. 21 
9.2 
EVALUATION AT DISCHARGE FROM THE SPECIFIC CLINICAL SETTING ........... 22 
9.3 
EVALUATION AT 3 MONTHS OF DISCHARGE .................................................. 23 
9.4 
EVALUATION AT 12 MONTHS OF DISCHARGE ................................................ 23 
9.5 
END OF THE STUDY EVALUATION ........................................................... 23 
10. ECONOMIC EVALUATION .............................................................................................. 26 

 
 
3 
11. APPENDIX ........................................................................................................................... 30 
12. REFERENCES ...................................................................................................................... 84 
 

 
 
4 
 
SIGNATURE PAGE 
 
STUDY TITLE: FEASIBILITY AND EFFECTIVENESS OF THE 
IMPLEMENTATION OF PROGRAMS TO SCREEN AND MANAGE 
OLDER PATIENTS IN DIFFERENT CLINICAL SETTINGS 
 
STUDY CODE: FRAILCLINIC 
 
I confirm I have read and understand the present protocol and I agree to perform the 
study according to what is recorded on it and to the applicable legal requirements. 
 
______________________ 
 
 
 
 
__________________ 
SPONSOR 
 
 
 
 
 
DATE 
 
_______________________ 
 
 
 
 
__________________ 
PROJECT COORDINATOR 
 
 
 
DATE 
Prof. Leocadio Rodríguez Mañas 
 
 
 
 
 
 
________________________  
 
 
 
_________________ 
SCIENTIFIC COORDINATOR 
 
 
DATE  
Name 
Site 

 
 
5 
1 ABREVIATIONS 
 
ADL 
Activities of  Daily Living 
AE 
Adverse event 
GDS 
GeriatricDepresionScale 
FC 
F r i e d ’ s C r i t e r i a  
EC 
Ethics Committee 
eCRF 
Case Report Form 
GCP 
Good Clinical Practice 
EQ-5D 
EuroQolfive-dimensional (EQ-5D) 
CRO 
Contract Research Organization 
IADL 
Instrumental Activities of Daily Living 
INE 
Instituto Nacional de Estadística (Spain) 
ICF 
InformedConsentForm 
MMSE 
Minimental State Examination 
SPPB 
Short Physical Performance Battery 
PASE 
Physical Activity Scale for the Elderly 
CAM 
Confusion Assessment Method 
ICER 
Incremental cost-effectiveness ratio 
PI 
Principal Investigator 
HUG-GRT 
Hospital Universitario de Getafe-Servicio de Geriatría 
 

 
 
6 
 
2 INTRODUCTION 
2.1 BACKGROUND INFORMATION: 
 
Disability is the main consequence of the concurrence of three conditions in old people: 
the ageing process, lifestyle processes and health-related conditions. 
As it has been the case with other relevant organizations and bodies, in its 2012 Ageing 
report, the European Commission and the Economic Policy Committee stated that coping 
with the challenge posed by an ageing population and a trend toward increases in age-
related spending will require determined policy action in Europe, particularly in: (a) 
reforming pension, health care and long-term care systems, and (b)  the reduction of 
disability and dependence through appropriate action with a special focus in fighting 
against disability (DG ECFIN & AWG, 2012). 
Disability is usually preceded by a state characterized by a decreasing capacity to respond 
to demands, caused by diminishing functional reserve. This condition has been named 
frailty, a disorder that may precede by several years the development of disability (1) and 
other clinical outcomes. When the frailty threshold has been surpassed and disability has 
emerged, recovery from disability is unlikely (2), especially as the age of the patient, the 
degree of disability or its duration increase (3). In contrast, frailty is reversible, as it has 
been shown both spontaneously (4, 5) and by interventions based on physical exercise (6). 
Moreover, and differently from chronic disease, the predictive capacity of frailty for 
adverse outcomes increases as the age of the population increases (8) becoming the most 
common condition leading to death among community-dwelling older persons, followed 
by organ failure (21.4%), cancer (19.3%) and dementia (13.8%) of dying. 
 
The aim of the present study is to assess the feasibility and effectiveness of programs 
designed to detect and manage frail older patients in high risk clinical settings, and to 
avoid functional impairment and other associated adverse outcomes. 
 
 
 

 
 
7 
 
2.2 RATIONALE OR JUSTIFICATION 
 
The prevalence of frailty in people older than 65 years is high, ranging from 7 to 16.3 %, 
and this increases with age (1, 9, 10). 
The most accepted approach defines frailty as ǲan age-associated biological syndrome 
characterized by a decrease in biological reserve and resistance to stress, due to a decline 
in several physiological systems, placing the individual in a special risk category when 
facing minor stressors and associated with poor outcomes (disability, death and 
hospitalization)ǳ  (11-14). 
Frailty is an established and credible concept which provides the framework for the 
relationships between ageing, disease, vulnerability, disability, and dependency (15). with 
its high prevalence in older people and its potential reversibility, make frailty the perfect 
target to overcome the challenge of disability in older adults(16). 
The challenge for Health Systems is develop strategies to detect this syndrome and the 
prevention the functional decline and disability. As a consequence, a complementary 
strategy is needed, supporting clinicians to provide personalized, comprehensive 
continuity of care (17).  
Older frail patients are prone to develop functional impairments, to be institutionalized 
and to die early. Additionally, they use Health and Social facilities much more frequently 
than their same-age counterparts, being at high risk for mis-, under- and over 
management. Some of these specific needs are covered by classical Geriatric facilities 
available in many European Hospitals. But these facilities only attend to 10-15% of all the 
frail older patients that are being seen and managed by other parts of the health care 
systems (14) 
It has been largely recommended that programs must not only identify at-risk patients so 
that they may benefit from specialized management, but they must also target the process 
of care (Lafont E et al., JNHA 2011) to 1) provide the best-fitted models of care to their 
needs, and 2) adapt the management of their diseases and conditions (cancer, major 
surgery, heart disease, etc.) to their special features (18). In this regard, recent 
publications have stated that this approach should be standard practice, and is supported 
by a wealth of evidence (19), mainly in frail elderly patients being attended in some 
specific high risk settings as described in our proposal (20-23). 

 
 
8 
FRAILCLINIC project includes two consecutives phases: the first one focus on detection 
and quantification of frailty (observational phase) and the second phase focus on 
management of frail patients by an integrate model of geriatric care (interventional 
phase).  In the observational phase we have evaluated the prevalence of frailty, the success 
of a program for detection frail patients in high risk clinical settings, tools commonly used 
for assessment of frailty and causes of no implementation. In the interventional phase we 
will analyse the effect of the performance of a geriatrician agreed with the treating 
physician/surgeon of the patient in these clinical settings comparing with the traditional 
performance.   

 
 
9 
3 OBJECTIVES 
3.1 PRIMARY OBJECTIVE: 
To assess the feasibility and effectiveness of programs designed to detect and manage frail 
older patients in high risk clinical settings, and to avoid functional impairment and other 
associated adverse outcomes. These high risk settings will be medical wards (cardiology, 
oncology or nephrology), major surgery wards and Emergency rooms. 
 
3.2 SECONDARY OBJECTIVES: 
 
o Determine the feasibility of implementing clinical and therapeutic approach to 
geriatric physician in elderly patients in high risk clinical settings  
o Determine disability by evaluating basic and instrumental activities of daily living 
in frail elderly patients treated in high risk clinical settings.  
o Establish functional status in frail elderly people seen in high risk clinical settings. 
o Evaluate quality of life through an instrument validated in frail patients seen in 
high risk clinical settings. 
o Establish mortality ratio in frail patients included in high risk clinical settings. 
o Obtain the rate of re-hospitalization in frail patients seen in high risk clinical 
settings. 
o Determine the average stay of hospitalization in frail elderly patients treated in 
high risk clinical settings. 
o Obtain the rate readmission to emergency room and hospitalization in frail older 
patients treated in high risk settings.  
o Determine the average stay of hospitalization in frail elderly patients treated in 
high risk clinical settings. 
o Determine the rate of delirium in frail elderly patients in high risk settings.  
o Obtain the rate of health-care associated infections in frail older patients seen in 
high risk settings.  
o Determine the rate of polypharmacy in frail older patients seen in high risk 
settings. 
o Establish the secondary institutionalization rate accordingly to decline the 
functional status in frail elderly patients in high risk settings.  

 
 
10
o Determine the need for a caregiver as a result of decline the functional status in 
frail older people in high risk settings.  
o Establish the caregiver burden in hospitalized frail patients on high risk settings.  
o Establish the secondary institutionalization rate accordingly to decline the 
functional status in frail elderly patients in high risk settings.  
o Determine the need for a caregiver as a result of decline the functional status in 
frail older people in high risk settings.  
o Establish caregiver burden of frail elderly patients seen in high risk settings.  
o To evaluate the cost-effectiveness of the intervention compared with usual care 
from the perspective of society and the health system. 
o To evaluate the cost-utility of the intervention compared with usual care. 
 

 
 
11
4 OUTCOMES 
4.1 PRIMARY OUTCOMES: 
 
1. Disability: It was measured by the Barthel Index for basic Activities of Daily Living 
and the Lawton index for instrumental activities of daily living. 
2. Functional status and performance-based measures: Functional status and 
performance-based measures: Is measured by Short Physical Performance Battery 
(SPPB), Physical Activity Scale for the Elderly (PASE SCALE). 
3. Quality of Life: Quality of life was assessed by self-reported questionnaire EuroQL 5D 
5L. It will be measured during admission to hospital and follow-up. 
4. Geriatrician Intervention: The impact of their intervention is measured by 
quantifying in a register any additional tests requested and medical advice by other 
specialists. 
 
4.2 SECONDARY OUTCOMES: 
 
Prevalence of Delirium: The delirium cases are detected by Confusion Assessment 
Method (CAM) scale.  
Cognitive Impairment: Will be measured by the Mini Mental State Examination (MMSE) 
in the initial assessment. 
Depression: will be assessed using the Geriatric Depression Scale in the baseline 
assessment. 
Health-care associated infections: Acquired during hospitalization start. 
Geriatric Syndromes: The geriatric evaluation including the following aspects: clinical, 
functional, mental and social.  
Comorbidity:Will measured at initial assessment thorough Charlson index 
Nutritional Status: Will measured at initial assessment thorough the Mini Nutritional 
Assessment and body Mass index. 
Polypharmacy: Defined as five or more prescription drugs. 
Mortality rate: Number of deaths during follow-up. It is calculated using official report of 
the National Statistics Institute (INE). 
Average stay hospitalization: Average length of stay of stay all discharges. We will obtain 
from Hospital Admissions service. 

 
 
12
Hospitalization Rate in Emergency room:  Number of hospital admissions over the total 
of patients admitted in the hospital. 
Readmission rates: Number of readmissions during of follow-up period. I will get the 
data in Hospital Admissions Service. 
Institutionalization: Number of patients referred to nursing home after discharge or at 
any time during follow-up. This information is obtained directly from patients or their 
relatives. 
Requirement of caregiver: Number of patients who require a caregiver after hospital 
discharge. 
Caregiver burden: Will be used Zarit Scale for assessing caregiver burden 
Cost-effectiveness: The incremental cost-effectiveness ratio (ICER) was assessed by 
measuring the difference in health outcomes per unit cost. 
Cost-utility: is measured using the QALY (unit of measurement of preferences of 
individuals with regard to the quality of life that has occurred through a health 
intervention, combined with the years earned for a given health state). 
 

 
 
13
 
5 STUDY DESIGN 
This trial is designed as a randomised, multicenter, phase III trial to evaluate the feasibility 
and viability of clinical and therapeutic approach frail older people in high risk clinical 
settings (Emergency room, General Surgery, Oncology, Cardiology, and Nephrology). 
Patients will be randomized on a 1:1 basis to receive either usual treatment or usual 
treatment plus geriatric interventions. 
 
The patients will be recruitment in Spain, Italy and United Kingdom. In Spain will be 
included the following centres: Hospital Universitario de Getafe (Madrid), Hospital 
Universitario Central de Asturias Monte Naranco (Asturias); In Italy: Ospedale San 
Raffaele (Rome), Universitat´Cattolica del Sacro Cuore(Roma), in United Kingdom: (Cardiff 
University and other one to be determined)According to feasibility in each centre will be 
recruitment 
patients 
from 
differents 
clinical 
settings. 
See 
Table 
 
No 
1

 
 
14
 
Table 1. Recruitment distribution of patients according to hospital and setting  
 
 
Hospital 
 
Setting 
Hospital Universitario de Getafe. 
(Madrid - Spain) 
Emergency room 
Cardiology ward 
Elective Surgery 
Emergency Surgery 
Hospital Universitario Monte Naranco. 
(Asturias - Spain) 
Oncology 
Elective Surgery 
Emergency Surgery 
Professor Sinclair 
(England – United Kingdom) 
Emergency room 
Cardiology Ward 
Elective Surgery 
Cardiff University (Wales - Reino Unido) 
Emergency room 
Nephrology ward 
Elective Surgery 
Ospedale San Raffaele 
(Rome - Italy) 
 
Cardiology Ward 
Universita' Cattolica del Sacro Cuore 
(Rome - Italy) 
 
Emergency Room  
Cardiology Ward 
Elective Surgery 

 
 
15
6 ELEGIBILITY 
6.1 INCLUSION CRITERIA: 
 
Participants must meet all of the following inclusion criteria to be eligible to 
register for this trial: older than 75 years old diagnosed of frailty, according to 
Fried’s Criteria, if is not possible to use the Fried Scale, FRAIL Scale will be used. 
6.2     EXCLUSION CRITERIA: 
 
Do not able to give informed consent.  
 
Participants with moderate-severe cognitive impairment according to MMSE scale 
(score 18 or lower) and/or the GDS scale (score 5 or higher)*.  
 
Those with physical disability according to Barthel Index (lower to 40)  
 
Participants with critical acute disease who might need admission in an Intensive 
Care Unit (ICU). 
 
Life expectancy lower than six months 
 
Nursing home residents 
 
* This cut-off was selected to establish a higher sensitivity and maintain a good 
recruitment rate.(24) 
 
 
 
 

 
 
16
 
7 RECRUITMENT 
 
Participants will be recruited in Spain, United Kingdom and Italy according to legal 
requirements in each country. Also, we will obtain the committee approbation in the 
hospitals, as well as, doing a contract in each hospital.  The administrative matters will be 
handled by CRO Business&Decision Life Sciences (Contract Research Organization). 
 
7.1 INFORMED CONSENT AND ELEGIBILITY CRITERIA 
 
Potential participants will be evaluated by authorized members of the clinical trial who 
will be trained to provide the necessary information to adequately explain the trial 
protocol and solve the issues that arise from the possible candidate to join the study team. 
If necessary, several members of the research team should discuss and solve the doubts 
concerns of the patient. 
The team member will be willing to answer questions from potential participants verbally 
or in writing if necessary in simple, clear and understandable language. Upon acceptance 
by the participant, potential eligibility criteria shall be formally evaluated, if they do, he or 
she shall sign the informed consent (Annex 1) 
The Principal Investigator (PI) will have overall responsibility for solving any problems 
that might arise about informed consent and supervise all study participants to ensure 
that everyone involved in this process are properly trained according to the ethics 
committee approval protocol and Guides of Good Clinical Practice (GCP) and the 
Declaration of Helsinki of 1996. 
Informed consent will be obtained before the participant is assessed by specialists with 
the purposes of the study. The right of a participant to refuse to participate without giving 
reasons will be respected. The participant may withdraw at any time without giving 
reasons and without prejudice to his / her further treatment. At no time during the 
process of obtaining informed consent the investigator or any member of the research 
team coerce or influence for the patient to be part of the clinical trial. 

 
 
17
The investigator will check if the participant has successfully completed the consent form 
and that it has been signed and dated correctly. The researcher must sign and date the 
form in the right area on the same date as the participant. The original informed consent 
will be filed in the archive of the researcher. 
If a participant is ineligible after randomization, it shall be reported immediately to the 
principal investigator. 
Patients who during the follow up present a moderate or severe cognitive impairment will 
remain in the group assigned. 
 
7.2 RANDOMIZATION 
 
After verification that the participant fulfils the eligibility criteria and signed the informed 
consent, allocation will be made to a control or/an intervention group.  
Participants will be randomized 1:1 through the eCRF by Linkcare Company, which also 
will do the database. 
Patient’s participation in the study and the telephone number of the study contacts will 
always be registered in his/her clinical record. 
According to the study’s schedule, the intervention phase will start the sixteenth week, 
taking into account the adjustments of the ethics committee in each country. Follow-up 
will be made at hospital discharge and at the third and sixth month after discharge.  
7.3 SAMPLE SIZE 
 
Dependence and disability affects quality of life perception and increases health costs. 
Hence, this variable will be taken to calculate sample size. According to literature, the 
incidence of disability in frail older people is approximately 40%. 
In order to avoid the estimation bias, the sample size will have at least 10 outcomes as 
variables. Therefore, the formula has been calculated for a 95% confidence interval to 
obtain at least 40 events. 
 

 
 
18
 
)
1(
*
*
*
2
1
p
p
n
z
p
n



 
 
It has been assumed drop-out rate of 20% and an incidence of disability described above. 
Hence, the sample size should be at least 1860 participants. In each clinical setting 
(emergency room, general surgery, oncology, cardiology and nephrology) 310 participants 
should be evaluated (155 in each group: control and intervention). 
In case of not obtaining the minimal sample size in each clinical setting, the pondeate 
models will be made. Additionally, a meta-analysis will be performed including the global 
effect of the intervention according to clinical setting and with a thorough sensitivity 
analysis.  
 
7.4 STATISTICAL ANALYSIS 
Firstly, subject’s basal characteristics at recruitment will be analyzed. Descriptive statistics 
of epidemiological and clinical data will be calculated (described in section 9). This 
analysis will be done in a conjoint manner, according to treatment and clinical setting 
(emergency room, general surgery, oncology, cardiology, and nephrology). 
To verify the differences between the arms of the study a Mann-Whitney test will be made. 
Based on the inclusion criteria, it is expected that the differences will be produced by the 
intervention, and not because of differences between groups. 
To evaluate the intervention in each clinical setting, the effect of the intervention and its 
statistical significance will be determined. 
These effects shall be broken down into two classes depending on the event. First the 
prevalence rate, and in case the event’s duration could be assessed, evaluate if this 
duration has changed.. 
For each outcome described in section 4, comparisons between predictive values of the 
logistic models for each scale will be made in order to determine which scale is optimal in 
a global manner, according to clinical setting.  
In case the date of death and hospitalization can be obtained, survival models will be done.

 
 
19
 
Diagram 1. Flowchart of randomized clinical trial 
 
 

 
 
20
8 INTERVENTION AND CONTROL 
 
8.1 CONTROL GROUP 
 
Patients will receive medical attention according to usual medical/surgical treatment and 
the peculiarities of each pathology and clinical setting. In this Group of patients a 
Comprehensive Geriatric Assessment will be done at hospital admission and discharge. If 
at any case, a geriatrician consultation is required, it should be registered in the eCRF and 
in patient’s record. The statistical analysis of these patients’ data should be made, if there’s 
enough sample throughout a sensitivity analysis.  
 
8.2 INTERVENTION GROUP 
 
Patients included in this Group will be treated by usual physician with the support of 
geriatrics team, who will do Comprehensive Geriatric Assessment to detect any problem in 
the elderly population in the clinical, functional, mental and social domains. The objective 
is to establish a strategy of intervention, treatment and follow-up to optimize resources 
and improve independency and quality of life.. 

 
 
21
 
9 ASSESMENTS DURING THE STUDY 
 
9.1 BASELINE EVALUATION (visit 0= FIRST VISIT) 
 
After the inclusion of a participant in the study, a comprehensive geriatric assessment will 
be done with the following parts: 
Demographics and epidemiology:Date of birth, age, sex, race, caregiver, marital status, 
number of persons in the house, and, number of hospitalization in the last year, follow up 
by others specialist, level of education. 
 
Medical history  
Personal Medical and Surgery History should be recorded in the electronic Case Report 
Form (eCRF). 
 
Medications: 
In the CRF  we register all the regularly  medication use (previous hospitalization) 
 
Functional status  
Evaluate functional status with the following scales: Barthel Index, Lawton Index, 
measures based in performance (SPPB-Short Physical Performance Battery) and PASE 
Scale, Annex 2. 
 
Cognitive and depression: 
Evaluate the results with   MMSE and Geriatric Depression Scale GDS, and delirium risk 
with CAM scale. See  Index 2. 
 
Physical examination: 
Vital signs and physical examination as usual by the clinical investigator. 
 
Geriatric Syndromes Assessment: 
Immobility: Falls and imbalance. 
Incontinence: urinary and fecal. 
Sensory deprivation 
Iatrogenic: Record the numbers of falls during the hospitalization and  adverse effects 
Pain: assess pain using the VAS Scale. Nutritional Status: 

 
 
22
Performed screening for nutritional status using the scale MNA (Mini Nutritional 
Assessment), Index 2. 
 
Comorbidities: 
Comorbidities will be quantified by Charlson Index,  Index 2. 
Quality of Life : 
The evaluation for the quality of life using the EuroQolfive-dimensional (EQ-5D), Index  2. 
Caregiver : 
 
Assessment for the burden of the caregiver; Will be evaluated with The Modified 
Caregiver Strain Scale. Index 2. 
 
9.2 EVALUATION AT DISCHARGE FROM THE SPECIFIC CLINICAL 
SETTING 
 
The following aspects will be assessed:  
 
Mortality 
 
Frailty assessment with L. P. Fried’s scale and/or FRAIL scale. Functionality 
assessment with Barthel Index. Indicate the number of hospital stay in days . 
 
Describe if the patient change the Ward location/ medical /surgical in the hospital 
( UCI, Coronary unitetc) o )during the evolution in the hospital  
 
Quantification the number of test (Blood test, urine test, X- Ray, ecography, CT, etc  
and more specialized like:  PET TAC, echocardiography, polisomnography, etc.) 
 
Quantification the number of consult with other specialist, social worker, paliative 
care. Etc.   
 
Usual treatment   ( Register all the meditation at discharge 
 
Evaluate if the patient develop geriatric síndrome (page  22). 
 
Destination at dischargeia. (Nursing home, follow up by home care team, l HUG-
GRT, day hospital, rehabilitation at home , specialist consultation, etc.) 
 
Evaluate the perception of the quality of life with the scale EuroQolfive-
dimensional (EQ-5D). 
 
Burden of the caregiver with the Economics questionnaire s. 
 
Economics evaluation Index 3  
 
 

 
 
23
9.3 EVALUATION AT 3 MONTHS OF DISCHARGE 
 
Re-evaluate the following aspects by phone : 
 
Mortality 
 
 
Functionality data (Barthel index ,  Lawton index , PASE Scale). 
 
Usual medication. 
 
Residency at the moment. 
 
Frailty with the FRAIL scale. . 
 
Data of quality of life with the scale  EuroQolfive-dimensional (EQ-5D) 
 
Number of hospitalization and ER, indicate the cause (diagnosis) 
 
Caregiver burden with the economic questionaries . 
 
Economics evaluation, Index 3  
 
9.4 EVALUATION AT 12 MONTHS OF DISCHARGE 
Re-evaluate the following aspects by phone  
 
Mortality 
 
 
Funtionality data (Barthel index,  Lawton index , PASE Scale). 
 
Usual medication. 
 
Residency at the moment. 
 
Frailty with the FRAIL scale. Datos de fragilidad con la escala FRAIL. 
 
Data of quality of life with the scale  EuroQolfive-dimensional (EQ-5D) 
 
 Number of hospitalization and ER, indicate the cause ( diagnosis)  
 
Burden of the caregiver with the economics questionnaires. 
 
Economics evaluation., Index 3  
 
9.5 END OF THE STUDY EVALUATION 
 
 
The study will finish at 12 months after patient’s discharge with a lastphone call . 
 
We should make an effort to write all the data during the study, at follow up and 
the final evaluation. .  
A follow-up and investigator’s tasks schedule was performed during the study. See 
table 2.  

 
 
24
 
Table 2 Schedule of the investigation  
Intervention phase 
 
 Eligibility&recruitment 
Initial 
Visit 
Discharge 3 month 
Follow-
up  
12 month 
Follow-up  
Informed consent 
X 
 
 
 
 
  Eligibility CI and CE  
X 
X 
 
 
 
Medical history 
 
X 
 
 
 
Usual treatment 
 
X 
X 
X 
X 
Comprehensive Geriatric 
Assessment 
 
X 
 
 
 
 
Cognitive and depression 
(MMSE,GDS,CAM) 
 
X 
 
 
 
Comorbidities -  Charlson I. 
 
X 
 
 
 
Functional Status  
(Barthel I, Lawton I, PASE, 
SPBB) 
 
X 
SPBB 
X 
Barthel 
 
X 
 
X 
Sociodemographic data  
 
X 
 
 
 
PhysicalExam 
 
X 
 
 
 
Nutritional Status  (MNA) 
 
X 
 
 
 
Permanent residence 
 
X 
X 
X 
X 
Mean hospital stay 
 
 
X 
 
 
Death 
 
 
X 
X 
X 
Frailty (Fried) 
 
X 
X 
 
 
Frailty(FRAIL) 
 
X 
X 
X 
X 
EuroQolfive-dimensional (EQ-
5D) 
 
X 
X 
X 
X 
Caregiver burden 
 
X 
X 
X 
X 
Relocation to other hospital 
services 
 
 
X 
 
 
Adverse events  (iatrogenic, 
falls, geriatric syndromes, etc.)  
X 
X 
 
 
Economics evaluation 
 
 
X 
X 
X 
Checklist of complementary 
test during the hospitalization 
 
 
X 
 
 
Consultation to other specialist 
during hospitalization 
 
 
X 
 
 

 
 
25
Coordination of care in 
different levels of care 
 
 
X 
 
 
Readmission 
 
 
 
X 
X 
Visits to the emergency room 
 
 
 
X 
X 
Nosocomial infections 
 
 
X 
 
 
 
* In case of surgical patients, who after 3 weeks since the first visit have passed and 
surgery hasn’t been performed, evaluate the possibility of re-assessing inclusion criteria. 

 
 
26
10  ECONOMIC EVALUATION 
 
An economical evaluation of the program will be conducted to detect and handle the frail 
elderly in different health areas. We will conduct a comparative analysis in terms of costs 
and benefits of a geriatrician’s intervention compared with usual care. 
Information on both patients and caregivers about health resources and social services 
use and time spent by the caregiver will be collected. The next step is to translate this 
resource consumption in monetary terms. The costs will be reported in euros and in 
places where it is not used this coin the current exchange will take place. 
The total cost is the sum of three different types of costs: directly derivatefrom care; 
formal care costs (professional) and informal care costs (family and friends) 
Direct health care costs: 
These costs are related to inpatient treatment, outpatient treatment, medicines, etc. These 
are estimated from the use of health services by assigning a monetary value for each 
resource used. 
Health resources will be identified and measured through questionnaires. Each center will 
give us the price or the monetary value of each resource. If some of this information is not 
available, it will be obtained from a systematic review of studies of cost of illness for each 
country. 
Formal care costs (Social Services): 
Formal care includes those generated by social services which can be public or privately 
funded institutions such as day care centers, remote assistance, scheduled home care, etc. 
These costs will be identified, measured and evaluated through questionnaires. Ideally, 
members of each research team from each center must provide to the economic team 
price and monetary values (unit costs) of resources for social services. 
If data about unit cost of social services are not available, a review of the literature will be 
performed to obtain the data by country. 
 
 

 
 
27
Social costs (informal care) 
Informal care includes different types of unpaid support which serve to compensate for 
the inability of subjects, usually provided by relatives or friends. This information is 
obtained from questionnaires applied directly to caregivers in which time spent on 
helping the elderly in basic Activities of Daily Living and Instrumental Activities will be 
specified. The time spent on these activities will be evaluated in monetary terms using 
'proxy goodmethod "or" replacement method "which assesses the time spent on informal 
care adjusted to market prices of a professional who has to do this work (social service 
Careful formal). 
The economic evaluation will be developed to take into account several aspects: financing 
health care (including only direct health costs), finance formal care (including the direct 
costs of health and social services) and social perspective (including all relevant costs: 
direct medical care + formal care (social services) and informal care.  
Outcome measures: 
Cost-effectiveness analysis 
The cost-effectiveness analysis (CEA) is the most common test used in health economics to 
decide between different treatments for the same condition. In a CEA, the costs are 
measured in monetary units, while the benefits are measured as outcomes or in natural 
units. "Incremental cost-effectiveness ratio" (ICER) is estimated to show a difference in 
health outcomes per unit cost, after a follow-up period between intervention and usual 
care. The incremental cost-effectiveness is expressed by the following relation:  
ICER  Ca  Cb
Ba  Bb
 
Where Ca is the cost of the intervention group and Cb is the cost of the usual care group. 
Ba will be health benefits in the intervention group and Bb health benefits in the usual 
care group, both measured in terms of change of the clinical results of the baseline. 
In this study the primary outcomes will be the difference in functional status after the 
intervention compared with usual care group. This study will assess the cost-effectiveness 
of the intervention of a geriatrician compared with usual care from the perspective of 
society and the health care system. 

 
 
28
Complementing the main cost-effectiveness analysis, we will develop several parallel cost 
effectiveness analysis to the extent that effective change. The results that we will use are: 
hospitalization rate and readmission, lenght of hospitalization and in the Emergency 
department, episodes of delirium and nosocomial infection, post-surgical complications as 
a whole and by surgical procedure, number of inappropriate drugs, adherence to 
treatment, permanent institutionalization rate, survival rate, preventable side effects due 
to under / over / mismanagement on caregiver burden. 
 
Cost-utility analysis: 
Cost-utility analysis (ACU] is an evolution of cost-effectiveness analysis, in which the 
interference effects are measured in a unit that synthesizes the lifespan and quality of life. 
The best and better known measure is the quality of life-adjusted per quality (QALY QALY 
or in its Anglo-Saxon sense). The QALYs are calculated by weighting the survival time 
(years of age) with quality adjustment thereof, called utility, which represents the 
preference values in relation to different health states (reference). For the purpose, the 
EQ-5D-5L instrument will be used. The incremental cost-utility relation answers the 
following expression: 
ACUincremental = (Ca – Cb) / (AVAC(a) – AVAC(b)) 
Statistical analysis: 
A descriptive analysis of the main resources used in health care, social services and 
informal care will be performed. 
This includes basic statistics such as means, medians, standard deviations, skewness, 
kurtosis, ranges, bivariate analysis using different cost elements and individual 
characteristics (sex, age,...) and health outcomes. 
Because different distributions are expected from major cost components, we hope to 
develop different multivariate estimation methods. As we expect a non-normal 
distribution of the estimated costs, an alternative analysis would be the use of GLM models 
grouped by clusters, where depending on the distribution of the estimated costs 
(distribution Gamma, Poisson or Gaussian), will be used the most suitable method of 
empirical analysis. Another alternative, if the necessary information is obtained, could be 
an analysis using multilevel models of 2 or 3 grade (Recital country and center). The costs 

 
 
29
of health care could also be analyzed by a normal multivariate model (clustering) or log-
normal and the ordinary least square regression will be used to estimate the determinants 
of health care costs. In contrast, for the analysis of formal and informal care costs, we 
expect to use simple probit or ordered probit models, whether formal and informal care 
for a large number of people in the study is provided. 
 

 
 
30
11. APPENDIX 
APPENDIX  1 
 
STUDY TITLE: 
 
FEASIBILITY AND EFFECTIVENESS OF THE 
IMPLEMENTATION OF PROGRAMS TO SCREEN 
AND MANAGE FRAIL OLDER PATIENTS IN 
DIFERRENT CLINICAL SETTINGS 
 (Intervention phase). 
 
 
 
 
 
SUBJECT´S INFORMATION FORM 
 
 
Sponsor: FUNDACIÓN PARA INVESTIGACIÓN BIOMÉDICA 
DEL HOSPITAL UNIVERSITARIO DE GETAFE 
 
 
Project leader: Prof. Leocadio Rodríguez Mañas 
 

 
 
31
SUBJECT INFORMATION FORM 
Study Title: FEASIBILITY AND EFFECTIVENESS OF THE IMPLEMENTATION OF 
PROGRAMS TO SCREEN AND MANAGE FRAIL OLDER PATIENTS IN DIFERRENT 
CLINICAL SETTINGS 
Investigator: Prof. Leocadio Rodríguez Mañas. Hospital de Getafe. 
 
What is this study about? What are the outcomes? 
You are invited to participate in a research study because you are somebody who 
can meet the clinical criteria for frailty syndrome. 
 
This syndrome (frailty) includes criteria such as: weakness, weight loss, walking 
speed, among others. This syndrome is associated with higher risk of developing 
dependency and disability. Your physician has checked that you meet the criteria 
for diagnosis of this syndrome. 
 
In this study we evaluate the usefulness of a screening program of frail subjects 
using certain scales, and measure the benefit that suppose to the subject to 
associate the intervention of a geriatrician to usual clinical practice. In this study 
we will not test the efficacy of any new drug. 
 
The aim of this study is to assess whether, through the intervention of a 
geriatrician can change the course of frailty and reduce the occurrence of adverse 
events from the health point of view. 
 
A total of 1500 subjects are estimated to participate in 6 hospitals distributed by 
three European countries. The study was approved by the Ethics Committee of the 
Hospital Universitario de Getafe and ethics committees of the participating centers. 
It is also approved by the competent bodies of the regions concerned. It will be 
executed following the Declaration of Helsinki and the requirements of the Law 
14/2007 of Biomedical Research. The study will last for three years. 
 
 

 
 
32
How this study was done? 
Each hospital will select a group of approximately 250 individuals who meet the 
criteria to participate in the study. These people will be informed about the study 
and asked, if they agree to participate, to sign this informed consent form. Once 
subjects are selected through a randomized system (similar to throwing a coin), it 
is determined in which study group will participate. Half of the patients selected 
will participate in usual clinical practice group (control group) and half the group 
will receive care from a geriatrician (intervention group). 
 
If you belong to the control group, will follow the recommendations, actions and 
treatment indicated for your specialist doctor. Nothing will change of normal 
medical practice. 
 
Still, in order to assess the results of usual medical action a geriatrician will hold a 
series of questions when hospitalization, and following in three months and one 
year (the latter two are made by telephone calls). 
If you are allocated to the intervention group: you will be followed by your 
corresponding specialist as in usual clinical practice and by a geriatrician. The 
geriatrician will take into account his medical criteria, always with the consent if 
the rest of the physicians treating you. The geriatrician will make questions about 
your physical, mental, social and nutritional state.  
Follow-up will be made after discharge at 3 month and at 12 month (by telephone 
call). 
What are the potential benefits and risks associated to the study? You must 
know this study will be supervised by experienced health professionals as doctors 
and nurses. It is possible that you will not obtain any benefit for the study and you 
can even experience some secondary effect associated to any treatment or 
complementary test. Some of the information obtained in this study may help 
improve elders quality of life, improve the capacity of doing activities of daily living 
or avoiding institutionalization in some cases..   
 

 
 
33
 
Your participation is voluntary  
I you want to participate in this study, once you have read and understood this 
information form, and all of your questions have been answered, you must 
communicate your decision to your physician. You are free to abandon the study at 
any time without giving any explanations, and this will not change the relationship 
with your physician. Your physician could retire you from the study if you do not 
follow the given instructions or because he/she considers it will benefit your 
health status or on the assumption the study is cancelled. If this occurred, you will 
be informed the reason of its ending. 
Data collected at the moment of your abandonment will be used for the objectives 
originally foreseen.  
Review of the original documents, confidentiality and personal data 
protection.  
With the aim to guarantee feasibility of the collected data, the designated personal 
by the promoter, and eventually the health authorities and/or members of the 
Investigation Ethics Committee, will be allowed to access clinical records of the 
subject where you will be identified as main caregiver, always respecting 
confidentiality. Treatment, communication, and personal data transfer of every 
participating subject in this study will be adjusted to what is established in the Law 
15/1999 of Personal Data Protection.  
Data collected in the study will be identified by a numeric code and just the study 
physician and collaborators will be able to connect that data to you. 
Any additional information that could be identifiable will be kept and processed in 
a secure way by informatical media by the promoter or the company designated by 
him/her.  
Data could be transferred to other countries or collaborative groups in the study as 
long as they apply the necessary measures to protect personal information, 
transferring them in a coded way.  

 
 
34
You can exercise your right, according to current legislation, of rectifying, 
cancelling o opposing, according to your personal data, talking directly to your 
study physician.  
Results publication 
The study results will be communicated to the scientific community through 
congresses and/or publications. In any way, there will be no information that could 
identify you in these publications.  
If during the study, any relevant information that could be useful to you emerges, it 
will be communicated through your study physician.  
Additional information  
The study meets the current Spanish legislations(Law 14/2007 of Biomedical 
Investigation). According to the Spanish legislation, the  promoter commits to 
subscribe to an insurance policy before the beginning of the study to cover for 
adverse events that could be produced during the study. 
The patient should know that he/she will not receive any economic compensation 
or reimbursement of expenses due to its participation in the study.  
This study is financed by the CE ǲHEALTH-ʹͲͳ͵ǳ PROJECTS.  
You can discuss any of the information given with your attending, family or friends 
before taking any decision concerning your participation in the study. If you have 
any doubt or any event arises during the study, you can talk to:  
Name of the Investigation Clinician: Mónica Ballesteros. 
Address:  Carretera de Toledo, km 12,500, 28905 Getafe, Madrid 
Phone number: +34 916839360 ext. 2760 
You will be given a copy of this document with date and signature.  

 
 
35
Study Title: 
FEASIBILITY AND EFFECTIVENESS OF THE IMPLEMENTATION OF PROGRAMS TO 
SCREEN AND MANAGE FRAIL OLDER PATIENTS IN DIFFERENT CLINICAL 
SETTINGS. INTERVENTION PHASE. 
 
I,................................. (Name and Last Name)...................................................  
Have read the information form I’ve been given.  
I have been able to ask questions about the study.  
I have received enough information about the study. I have talked to: .......................... 
(Name of the Investigator) .......................... 
I understand that my participation is voluntary. I understand that I can abandon 
the study willingly:1º.Whenever I want. 
2º.Without giving any explication. 
3º.It will not change in any way my plan of care. I willingly give my consent to 
participate in the study. SUBJECT:  
 
Signature: 
 
 
 
 
 
 
Date 
Name 
 
INVESTIGATOR Signature:   
 
 
 
 
 
Date 
Name 
WITNESS (if needed):  
 
Signature 
 
 
 
 
 
 
Date Name:  

 
 
36
FRAILCLINIC 
 
STUDY TITLE: 
 
FEASIBILITY AND EFFECTIVENESS OF THE 
IMPLEMENTATION OF PROGRAMS TO SCREEN AND 
MANAGE FRAIL OLDER PATIENTS IN DIFFERENT 
CLINICAL SETTINGS (Intervention Phase) 
 
 
 
 
 
INFORMATION FORM FOR PRINCIPAL CAREGIVER  
 
Sponsor: FUNDACIÓN PARA INVESTIGACION BIOMÉDICA 
DEL HOSPITAL UNIVERSITARIO DE GETAFE 
 
Leader of the Project: Prof. Leocadio Rodríguez Mañas 
 
 
 
 

 
 
37
INFORMATION FORM FOR THE MAIN CAREGIVER 
 
Study Title::FEASIBILITY AND EFFECTIVENESS OF THE IMPLEMENTATION OF 
PROGRAMS TO SCREEN AND MANAGE FRAIL OLDER PATIENTS IN DIFFERENT 
CLINICAL SETTINGS.  
Investigator: Prof. Leocadio Rodríguez Mañas. Hospital Getafe 
What is the study about? What are the objectives? 
You are being invited to participate in an investigation Project because you are the 
main caregiver of a person who can meet clinical criteria of Frailty. You are the 
main caregiver because you are the one that helps him/her the most with 
Activities of Daily Living, or the one who is asked the most for help and is not hired 
for it.  
Frailty has different criteria as: weakness, weight loss, gait speed, among others. 
This syndrome is associated to a higher risk of dependency and disability.In this 
study we want to evaluate the usefulness of a program to detect frailty, with the 
use of determined scales, as to assess the benefits the subject obtains with 
associating a geriatrician’s intervention to the usual clinical practice. This study is 
not aimed to prove the efficacy of any new medication.. 
The study’s objective is to evaluate if the evolution of frailty and reduction of 
adverse events from the medical point of view can be changed through a 
geriatrician’s intervention.  
1500 subjects are estimated to participate in all 6 hospitals distributed in 3 
European countries. The study is approved by the Ethics Committee of the Hospital 
Universitario de Getafe and ethics committees in all of the other participating 
centers. It is also approved by the competent organs of the implied communities. It 
is going to be made following the Helsinki Declaration and the demands 
established by the Law 14/2007 of Biomedical Investigation. The study has a three 
years duration.  

 
 
38
. 
What is my participation about? 
Each health center will choose a group of 200 subjects who meet the participation 
criteria. These subjects will be asked to identify their main caregiver, if applicable. 
You, as caregiver, will be asked to answer two different polls about the subject’s 
care. They will be done three times; during hospitalization, at three month and at 
the first year of follow-up, the latest by telephone call.  
Which are the potential benefits and risks associated to the study? 
Participating in this study will not imply any benefit or risk because we are only 
asking you to fill questionnaires that will take some of your time. Obtained 
information in the study could help to improve quality of life of elders, improving 
their capacity to do certain activities or avoiding institutionalization in some cases. 
Your participation is voluntary 
If you want to participate in this study, once you have read and understood this 
information form, and all of your questions have been answered, you must 
communicate your decision to your physician. You are free to abandon the study at 
any time without giving any explanations, and this will not change the relationship 
with your physician. Your physician could retire you from the study if you do not 
follow the given instructions or because he/she considers it will benefit your 
health status or on the assumption the study is cancelled. If this occurred, you will 
be informed the reason of its ending. 
Data collected at the moment of your abandonment will be used for the objectives 
originally foreseen.  
Review of the original documents, confidentiality and personal data 
protection.  
With the aim to guarantee feasibility of the collected data, the designated personel 
by the promoter, and eventually the health authorities and/or members of the 
Investigation Ethics Committee, will be allowed to access clinical records of the 
subject where you will be identified as main caregiver, always respecting 

 
 
39
confidentiality. Treatment, communication, and personal data transferof every 
participating subject in this study will be adjusted to what is established in the Law 
15/1999 of Personal Data Protection.  
Data collected in the study will be identified by a numeric code and just the study 
physician and collaborators will be able to connect that data to you. Any aditional 
information that could be identifiable will be kept and processed in a secure way 
by informatical media by the promoter or the company designated by him/her. 
Data could be transferred to other countries or collaborative groups in the study as 
long as they apply the necessary measures to protect personal information, 
transferring them in a coded way.  
You can exercise your right, according to current legislation, of rectifying, 
cancelling o opposing, according to your personal data, talking direclty to your 
study physician.  
Results publication 
The study results will be communicated to the scientific community through 
congresses and/or publications. In any way, there will be no information that could 
identify you in these publications. If during the study, any relevant information 
that could be useful to you emerges, it will be communicated through your study 
physician.  
Additional information: The present study follows current Spanish legislation 
(Law 14/2007 of Biomedical Investigation). According to Spanish legislation, the 
promoter compromises to subscribe an insurance policy before the beginning of 
the study that covers for adverse events that could emerge during the study. You 
should know that you will not receive any economical compensation or 
reimbursement for any of the expenses associated to your participation in the 
study. This study is financed by the CE ǲHEALTH-ʹͲͳ͵ǳ PROJECTS.  
You can comment the information received with your physician, family or friends 
before making any decision concerning your participation in the study. Name of 
the study physician: Mónica Ballesteros 

 
 
40
Address: Carretera de Toledo, km 12,500, 28905 Getafe, Madrid 
Phone number:  +34 916839360 extension 2760 
You will receive a copy of this document with date and signature. Study title: 
Feasibility and Effectiveness of the Implementation of Programs to Screen and 
Manage Frail Older Patients in different clinical settings. 

 
 
41
 
Study Title 
FEASIBILITY AND EFFECTIVENESS OF THE IMPLEMENTATION OF PROGRAMS TO 
SCREEN AND MANAGE FRAIL OLDER PATIENTS IN DIFFERENT CLINICAL 
SETTINGS. INTERVENTION PHASE. 
 
I,................................. (Name and Last Name)...................................................  
Have read the information form I’ve been given.  
I have been able to ask questions about the study.  
I have received enough information about the study. I have talked to: .......................... 
(Name of the Investigator) .......................... 
I understand that my participation is voluntary .I understand that I can abandon 
the study willingly:1º. Whenever I want. 
2º.Without giving any explication. 
3º.It will not change in any way my plan of care. I willingly give my consent to 
participate in the study. SUBJECT:  
 
Signature: 
 
 
 
 
 
 
Date 
Name 
 
Investigator’s Signature : 
 
 
 
 
 
 
Date 
Name 
WITNESS (if needed):  
 
Signature  
 
 
 
 
 
 
DateName:  

 
 
42
 
APPENDIX 2 
FRIED’S CRITERIA 
1- Weight loss:  
We have to ask the patient if he or she has lost weight unintentionally in the 
past year, and if the loss was greater than 4,5 kg (10 lb). 
 YES (1) 
 NO (0) 
2- Exhaustion: 
 ǲI felt that everything I did was an effort during the past weekǳ 
 I could not get ǲgoingǳ 
 
If SOME (OR BOTH) answers are  YES, one point for frailty will be counted. 
 
3- Physical activity: 
Does the patient perform less than or equal to the physical activity 
indicated weekly? 
 
Men:   
< 383 kcal / week (walking < 2 hours and30 minutes / week) 
 
Women:  
< 270 kcal / week (walking  < 2 hours / week) 
 
 
We ask the patient to respond with YES or NO if he/she performs these 
activities.  
If they answer  YES, one point for frailty will be counted. 
 
4- Slowness: measured as the time it takes for the patient to travel 15 feet to 
their usual walking speed.  
 
SEX 
 
Height(CM)        
CUT OFF 
MEN 
 
≤ͳ7͵ cm                
>7s 
 
 
>173 cm 
 
>6s 
WOMEN        
≤ͳ59 cm                
>7s 
 
 
>159 cm 
                >6s 
This is done as follows: we will indicate to the patient to stand  immediately 
behind the starting line, we will tell him/her to start walking ǲas he/she 
usually doesǳ. The patient is then stopped. We will do the test  twice and we 
will take the best score of the two.  The time will be recorded in seconds.  
 
5- Weakness: Assessed by grip strength.  
 
BMI♂  
CUT-OFF 
 
BMI♀ 
 
 
CUT-OFF 
≤24 
 
<29kg  
 
≤23 
 
 
<17kg 
24,1-26 
<30kg  
 
23,1-26 
 
<17,3kg 
26,1-28 
<30kg  
 
26,1-29 
 
<18kg 
> 28 
 
<32kg  
 
>29 
 
 
<21 kg 
 

 
 
43
He/she will rest for about 30 seconds, and he/she will repeat the exercise 
two  more times. We will record the best of all results. 
 
 

 
 
44
FRAIL 
 
1.- Fatigue is  measured by asking respondents how much time during the past 4 
weeks they have felt tired with responses of ǲall of the timeǳ or ǲmost of the timeǳ 
scored as 1 point.  
 
2.- Resistance is assessed by asking participants if they have had any difficulty 
walking up 10 steps alone without resting and without aids.  
 
3.- Ambulation is assessed by asking if they had any difficulty walking several 
hundred meters alone  and without aids: a yes response is scored as 1 point. 
 
4.- Illness is  scored 1 for respondents who report 5 or more illnesses out of 11 
total illnesses:(hypertension, diabetes, cancer (other than a minor skin cancer), 
chronic lung disease, heart attack, congestive heart failure, angina, asthma, 
arthritis, stroke, and kidney disease). 
 
5.- Loss of weight is  scored 1 for respondents with a weight decline of 5 % or 
greater within the past 12 months based on self-report. 
 

 
 
45
EUROQL 5D 5L:( (25) 
Under each heading, please tick the ONE box that best describes your health 
TODAY 
MOBILITY 
I have no problems in walking about  
 
 
 
 
 
I have slight problems in walking about   
 
 
 
 
I have moderate problems in walking about  
 
 
 
 
I have severe problems in walking about   
 
 
 
 
I am unable to walk about   
 
 
 
 
 
 
 
SELF-CARE 
I have no problems washing or dressing myself   
 
 
 
I have slight problems washing or dressing myself  
 
 
 
I have moderate problems washing or dressing myself   
 
 
I have severe problems washing or dressing myself  
 
 
 
I am unable to wash or dress myself  
 
 
 
 
 
 
USUAL ACTIVITIES (e.g. work, study, housework,  
family or leisure activities) 
I have no problems doing my usual activities  
 
 
 
 
I have slight problems doing my usual activities   
 
 
 
I have moderate problems doing my usual activities  
 
 
 
I have severe problems doing my usual activities  
 
 
 
I am unable to do my usual activities  
 
 
 
 
 
 
PAIN / DISCOMFORT 
I have no pain or discomfort  
 
 
 
 
 
 
I have slight pain or discomfort  
 
 
 
 
 
 
I have moderate pain or discomfort  
 
 
 
 
 
I have severe pain or discomfort   
 
 
 
 
 
I have extreme pain or discomfort  
 
 
 
 
 
 
ANXIETY / DEPRESSION 
I am not anxious or depressed  
 
 
 
 
 
 
I am slightly anxious or depressed  
 
 
 
 
 
I am moderately anxious or depressed  
 
 
 
 
 
I am severely anxious or depressed  
 
 
 
 
 
I am extremely anxious or depressed  
 
 
 
 
 
 

 
 
46
 
We would like to know how good or bad your health is  
TODAY. 
 
This scale is numbered from 0 to 100. 
 
100 means the best health you can imagine. 
0 means the worst health you can imagine. 
 
Mark an X on the scale to indicate how your health is TODAY. 
 
Now, please write the number you marked on the scale in the 
box below.  
 YOUR HEALTH TODAY  = 
 
 
 
 
10
0 
20
30
40
50
60
80
70
90
100 
5 
15
25
35
45
55
75
65
85
95
The best health       
 you can imagine 
The worst health     
 you can imagine 

 
 
47
Barthel Index (Basic activities of daily living) 
 
Feeding 
0 = unable 
5 = needs help cutting, spreading butter, etc., or requires 
modified diet 
10 = independent 
 
 
 0                   5                  10 
Bathing 
0 = dependent 
5 = independent (or in shower) 
 
0                   5 
Grooming 
0 = needs to help with personal care 
5 = independent face/hair/teeth/shaving (implements 
provided) 
 
 
0                   5 
Dressing 
0 = dependent 
5 = needs help but can do about half unaided 
10 = independent (including buttons, zips, laces) 
 
 
0                   5                  10 
Bowels 
0 = incontinent (or needs to be given enemas) 
5 = occasionalaccident 
10 = continent 
 
 
0                    5                  10 
Bladder 
0 = incontinent, or catheterized and unable to manage 
alone 
5 = occasionalaccident 
10 = continent 
 
 
0                    5                  10 
Toilet Use 
0 = dependent 
5 = needs help, but can do something alone 
10 = independent (on and off, dressing, wiping) 
 
 
0                   5                10          
 
Transfers (bed to chair and back) 
0 = unable, no sitting balance 
5 = major help (one/two people,physical), can sit 
10 = minor help (verbal or physical) 
15 = independent 
 
 
 0                   5                10               15          
Mobility (on level surfaces) 
0 = immobile or < 50 yards 
5 = wheelchair independent (inc.corners)>50 yds 
10 = walks with help of one person (verbal or physical) > 
50 yards 
15 = independent (but may use any aid; for example, 
stick) > 50 yards 
 
 
 
0                   5                 10               15 
 
Stairs 
0 = unable 
5 = needs help (verbal, physical, carrying aid) 
10 = independent 
 
 
0                   5                 10 
 
TOTAL (0-100) 
 
 

 
 
48
THE  LAWTON INSTRUMENTAL ACTIVITIES OF DAILY LIVING 
SCALE 
 
 
 
 
 
 
 
 
 
 

 
 
49
GERIATRIC DEPRESSION SCALE (GDS)  
Choose the best answer for how you have felt over the past week:  
1. Are you basically satisfied with your life?  
 
 
 
 
 
YES / NO  
2. Have you dropped many of your activities and interests?  
 
 
 
YES / NO  
3. Do you feel that your life is empty? 
 
 
 
 
 
 
YES / NO  
4. Do you often get bored?   
 
 
 
 
 
 
 
YES / NO  
5. Are you in good spirits most of the time?  
 
 
 
 
 
YES / NO  
6. Are you afraid that something bad is going to happen to you?  
 
 
YES / NO  
7. Do you feel happy most of the time?  
 
 
 
 
 
 
YES / NO  
8. Do you often feel helpless?  
 
 
 
 
 
 
 
YES / NO  
9. Do you prefer to stay at home, rather than going out and doing new things? 
 
YES / NO  
10. Do you feel you have more problems with memory than most?  
 
 
YES / NO  
11. Do you think it is wonderful to be alive now?  
 
 
 
 
YES / NO  
12. Do you feel pretty worthless the way you are now?   
 
 
 
YES / NO  
13. Do you feel full of energy?  
 
 
 
 
 
 
 
YES / NO  
14. Do you feel that your situation is hopeless?   
 
 
 
 
YES / NO  
 
15. Do you think that most people are better off than you are?   
 
 
YES / NO 

 
 
50
CAREGIVER BURDEN: 
MODIFIED CAREGIVER STRAIN SCALE (CSS)  
Being available to help or regularly caring for someone can be difficult and 
disruptive.  Which of the following statements apply to you…? We have included 
some examples that are common caregiver experiences to help you think about 
each item. Your situation may be slightly different, but the item could still apply. 
For each statement, please circle one answer (Not at all; Sometimes; Often; or 
Always) as appropriate.  
 
1. It is inconvenient (e.g. because helping the person takes so much 
time or it’s a long drive over to help). 
 
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
 
2. My sleep is disturbed (e.g. because the person I care for needs help 
and is in and out of bed, or wanders around at night). 
 
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
 
3. It is a physical strain (e.g. because the person needs help with 
practical tasks for which effort or concentration is required). 
 
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
 
 
4. It is confining (e.g. because the person restricts free time or cannot 
go visiting). 
 
           Not at all 
 
Sometimes 
 
Often  
Always 
_______________________________________________________________________
_ 
5. There have been family adjustments (e.g. because helping the person 
has disrupted routine; there has been no privacy). 
 
Not at all 
 
Sometimes 
 
Often  
Always 
____________________________________________________________________ 
6. There have been changes in personal plans (e.g. had to turn down a 
job; could not go on holiday). 
 
Not at all 
 
Sometimes 
 
Often  
Always 

 
 
51
___________________________________________________________________________ 
 
7. There have been other demands on my time (e.g. from other family 
members). 
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
8. There have been emotional adjustments (e.g. because of arguments 
with the person). 
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
 
9. Some behaviour is upsetting (e.g. because of incontinence: or he or 
she resists help).           
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
 
 
10. It is upsetting to find the person has changed from their former self 
(e.g. they are so different from before). 
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
 
11. There have been work adjustments (e.g. because of having to take 
time off caring for the person). 
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
 
12. It is a financial strain 
 
Not at all 
 
Sometimes 
 
Often  
Always 
___________________________________________________________________________ 
 
13. I am feeling completely overwhelmed (e.g. because of worry about 
the person; concerns about how I will manage). 
 
Not at all 
 
Sometimes 
 
Often  
Always 
THANK YOU FOR YOUR TIME AND HELP 
 
 
 

 
 
52
 
RISK OF DELIRIUM - CAM(Confusion Assessment Method) 
 
 
 

 
 
53
SPPB (SHORT PHYSICAL PERFORMANCE BATTERY) 
 
 
 
 

 
 
54
 
PHYSICAL ACTIVITY SCALE FOR THE ELDERLY  (PASE) 
 
 
 
 

 
 
55
 

 
 
56
 

 
 
57
 
 

 
 
58
 

 
 
59
 
 
 
 
 
 

 
 
60
NUTRITIONAL ASSESMENT: 
 

 
 
61
CHARLSON INDEX 
 
 
Other important medical history:  
 
 Hypertension 
 
 
(   yes   /   no) 
 
 Dyslipidemia  
 
 
(   yes  /   no) 
 
 Osteoarthritis 
 
 
(   yes   /   no) 
 
 Mayor surgery  
 
 
(   yes   /   no) 
 
 Others: 
 
_______________________________________________________________________________ 
 

 
 
62
Short-term mortality predictor (< 3 years): score of 0: (12% mortality/year); score 1-2: (26%); 
score 
3-4: 
(52%); 
score 
> 
5: 
(85%).   

 
 
63
PAIN ASSESMENT ACCORDING TO VAS SCALE: 
 
 
 

 
 
64
COGNITIVE IMPAIRMENT, EMOTIONAL AND RISK OF DELIRIUM 
ASSESMENT: 
 
MINIMENTAL TEST (MMSE): 
 

 
 
65
 
 
 

 
 
66
 
 
 
 
 
 
 
 
 
 
 

 
 
67
ANEXO 3 
Patient’s information obtained from his/her clinical record 
(Baseline) 
 
1. 
Patient’s ID: _____________ 
2. 
(Register the generic names and total daily dose of drugs that the patient has 
taken during the last month) 
 
Name generic drugs  
 
 
 
Total daily 
dose 
(milligrams) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
68
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. 
3. Hospitalization 
What was the main cause of hospitalization? 
 
 
Diagnosis 
related 
Code Group 
(GRD) 
GRD description 
Mean stay 
(days) 
 
 
 
 
 
 
 

 
 
69
 
Questionnaire for the subject(baseline) 
1. 
Identification number_____________ 
2. 
Level of studies completed 
 oCan read and write 
o Primary 
 
o Secondary o University
 o None 
3. 
Is the place where you live of your property? 
  
o Yes  
o No 
4. 
Number of household members where the subject lives: ___ 
people 
5. 
Carer 
a. Do you need a carer to assist you with your daily 
activities? 
(for 
basic 
hygiene, 
to 
help 
you 
to 
move, 
administration of drugs, performing treatments, etc.Monitoring 
and supervision tasks are also included) 
  o Yes 
 
 
o No  Skip to question #6 
b. In the case of yes, who is your principal carer?  
o Family member  Fill in the carer questionnaire and skip to 
question #6 
o Another non-contracted person (friend)  Fill in the carer 
questionnaire and skip to question #6 
o Professional carer (contracted or provided by an entity) 
c. If you use the services of a professional carer,  
How many hours a week? ______ hours a week 
Who pays for the service and how much? 
 
 
o I pay the entire cost of  ______ € per hour 
 
 
(Alternative, if the subject does not know the cost per hour) 

 
 
70
 
 
o I pay the entire cost of  ______ € per month 
 
 
 
o The cost is covered by social security or another entity 
 o The cost is partially covered by social security or another entity, I 
pay____ € per hour 
 
(Alternative, if the subject does not know the cost per hour) 
 
 
o The cost is partially covered by social security or another entity, I 
pay ______ € per  month 
 
 
6. 
Hospitalisation 
Have youbeen admitted to hospital in the last 12 months? 
o Yes 
 
o No 
 
7. 
Health and social services you have required and days of 
service received by according to economic system during the 
last month and the last 6 months. 
Mark the services you have required, number of days received and form of 
payment. In case you have required a service and have not received it, note 
the reason number (see the possible reasons below the table). 
 
Kinds of services 
You 
have 
needed 
to 
receive..
. 
Days service received 
according to economic 
system 
Reason 
for which 
they have 
not 
received 
the 
service (*) 
Free of 
charge 
Direct 
paymen
t  
Mixed 
(public 
and 
private) 
During the last month... 
During the last month... 
 
1. Telecare 
 
___ 
days 
___ 
days 
___ 
days 
 

 
 
71
2. Domiciliary care /help 
 
___ 
days 
___ 
days 
___ 
days 
 
3. Day centre 
 
___ 
days 
___ 
days 
___ 
days 
 
4. Occupational centre or centre 
for cultural, recreational and 
leisure activities 
 
___ 
days 
___ 
days 
___ 
days 
 
5. Other: 
 
___ 
days 
___ 
days 
___ 
days 
 
In the last 6 months... 
In the last 6 months... 
 
6. Respite services: Temporary 
stays  
 
___ 
days 
___ 
days 
___ 
days 
 
7. Residential centres  
 
___ 
days 
___ 
days 
___ 
days 
 
8. Other: 
 
___ 
days 
___ 
days 
___ 
days 
 
(*) Reasons: 1 – Waiting list. 2 – Not available in the setting. 3 – Cannot pay it. 4 – Does not 
comply with any of the requirements. 5 – Other reasons.  

 
 
72
 
QUESTIONNAIRE FOR THE CARER (first contact-
baseline) 
The subject's principal informal carer (NOT CONTRACTED) fills in the questionnaire. 
The principal informal carer is the person who is in charge of the patient whose autonomy 
has been limited for health reasons, and the person who spends more time with him/her or 
who has a greater responsibility to him/her compared with the other members of the 
patient’s emotional environment. 
 
1. Identification number: ______________ 
2. Carer's date of birth (day/month/year): 
 
___/___/19___ 
 
3. Sex: 
 
 
 
 
o Female 
 
o Male 
4. Country: ___________ 
5. Nationality: ___________ 
6. Marital status: 
o Single 
o Married or cohabiting 
o Divorced o Separated 
o Widow 
oN/A 
7. 
Level of studies completed: 
o Primary 
o Secondary o University o None 
 
8. What is your relationship with the subject? Are you his/her… 
o Sibling 
o Grandchild o Son/daughter 
o Nephew/niece 
o 
Friend 
o Neighbour o Another (please specify) _________o N/A 
 

 
 
73
9. Do you live with the care recipient? 
o Yes  
oNo 
10. 
Since when have you cared for the subject?  
O Less than 1 year  
 
 
o between 4 and 6 years 
O between 1 and 2 years  
 
o More than 6 years 
O between 2 and 4 years  
 
o NA 
 
HEALTH RELATED PROBLEMS 
11. 
Have you had any health-related problem for caring the 
subject in the last 12 months? 
o YES 
o NO  skip to question #13 
 
12. 
 In case of YES, please specify if you suffer any or some of 
the following problems (multiple choice option): 
o I am depressed 
o I am in treatment because of caregiving 
o I am extremely tired 
o I have back pain 
 
WORK-RELATED PROBLEM 
 
13. What is your MAIN working situation? 
o I am employed 
o I am unemployed  

 
 
74
o Retired or pensioner  Skip to question #16 
o Domestic tasks  Skip to question #17 
o N/A  Skip to question #17 
 
14. Have you had any work-related problem for caring the subject in 
the last 12 months? 
o Yes 
 
 
o No  Skip to question #16 
 
15. 
In case of yes, please specify this 
o I requested___ days leave of absence 
o I was working ___ hours less a day for ___ days 
o I am working ___ hours less a day 
o I do not work less hours a day but I have problems fulfilling my 
working hours 
o I had to leave work because of illness the person I care 
o Other problems: _____________ 
 
16. Retirement (only to be answered in case the carer is retired or a 
pensioner) 
 
a. Have you had to retire early to care for the subject? 
o Yes 
 
 
o  No  Skip to question #17 
b. In case of yes, please specify:    
o I retired early at the age of___ years 

 
 
75
 
SOCIAL, FAMILY AND LEISURE TIME- RELATED PROBLEMS 
 
17. Have you had any family, social o leisure time-related problem 
for caring the subject in the last 12 months? 
o Yes 
 
 
o No  Skip to question #19 
 
18. 
In case of YES, please specify this(multiple choice option): 
oI had to reduce my leisure time 
o I have conflicts with my partner or my family 
o I have no time to see or visit my friends 
o I have no time to take care of myself or other people 
o I have failed to start a family / I have not been able to have 
children (or more  children) 
 
Regarding the role played by you as PRINCIPAL CARER... 
 
19. How much time do you invest in a normal DAY for each one of the 
activities? 
Please specify the approximate time you spend daily on each activity 
On basic hygiene and dressing or changing them 
 
............... 
hours 
 
............... 
minutes          a day 
On bathing or showering them 
 
............... 
hours 
 
............... 
minutes          a day 
On feeding them 
 
............... 
hours 
 
............... 
minutes          a day 
On helping them to move around within the house 
 
............... 
hours 
 
............... 
minutes          a day 

 
 
76
On cooking and preparing meals 
 
............... 
hours 
 
............... 
minutes          a day 
Administration of drugs 
 
............... 
hours 
 
............... 
minutes          a day 
20. How much time do you invest in a normal WEEK on each one of the 
following activities? 
Please specify the approximate time you spend weekly on each activity 
On helping them to travel outside the house 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to contact health care suppliers 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to organise home adaptations 
 
............... 
hours 
 
............... 
minutes          a week 
On shopping 
 
............... 
hours 
 
............... 
minutes          a week 
On financial, administrative or legal affairs 
 
............... 
hours 
 
............... 
minutes          a week 
On social and leisure activities 
 
............... 
hours 
 
............... 
minutes          a week 
Monitoring and supervision (falls) 
 
............... 
hours 
 
............... 
minutes          a week 
 
Regarding the role played by OTHER CARERS (e.g. the rest of the family) 
21. How much time in a normal DAY do other carers spend on each one of 
the following activities? 
Please specify the approximate time these people spend daily on each activity 
On basic hygiene and dressing or changing them 
 
............... 
hours 
 
............... 
minutes          a day 
On bathing or showering them 
 
............... 
hours 
 
............... 
minutes          a day 
On feeding them 
 
............... 
hours 
 
............... 
minutes          a day 

 
 
77
 
 
On helping them to move around within the house 
 
............... 
hours 
 
............... 
minutes          a day 
On cooking and preparing meals 
 
............... 
hours 
 
............... 
minutes          a day 
Administration of drugs 
 
............... 
hours 
 
............... 
minutes          a day 
22. How much time do other carers spend in a normal WEEK on each of the 
following activities? 
Please specify the approximate time these people spend weekly on each activity 
On helping them to travel outside the house 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to contact health care suppliers 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to organise home adaptations 
 
............... 
hours 
 
............... 
minutes          a week 
On shopping 
 
............... 
hours 
 
............... 
minutes          a week 
On financial, administrative or legal affairs 
 
............... 
hours 
 
............... 
minutes          a week 
On social and leisure activities 
 
............... 
hours 
 
............... 
minutes          a week 
Monitoring and supervision (falls) 
 
............... 
hours 
 
............... 
minutes          a week 

 
 
78
QUESTIONNAIRE FOR THE CARER (week 12) 
The subject's principal informal carer (NOT CONTRACTED) fills in the questionnaire 
 
*If it is the first contact that the care has with the study because 
the person that she/he looks after did not need a carer before or it 
is a different carer, the carer must fill the baseline`s questionnaire. 
 
1. Identification number______________ 
 
HEALTH RELATED PROBLEMS 
 
2. Have you had any health-related problem for caring the subject 
in the last 3 months? 
o YES 
o NO  skip to question #4 
 
3.  In case of YES, please specify this(multiple choice option):: 
o I am depressed 
o I am in treatment because of caregiving 
o I am extremely tired 
o I have back pain 
 
WORK-RELATED PROBLEM 
 
4.  WHAT IS YOUR MAIN WORKING SITUATION? 
o I am employed 

 
 
79
o I am unemployed  
o Retired or pensioner  Skip to question #7 
o Domestic tasks  Skip to question #8 
o N/A  Skip to question #8 
 
5. Have you had any work-related problem for caring the subject in 
the last 3 months? 
o Yes 
 
 
o No  Skip to question #8 
 
6. In case of yes, please specify this 
o I requested___ days leave of absence 
o I was working ___ hours less a day for ___ days 
o I am working ___ hours less a day 
o I do not work less hours a day but I have problems fulfilling my 
working hours 
o I had to leave work because of illness the person I care 
o Other problems: _____________ 
 
7. Retirement (only to be answered in case the carer is retired or a 
pensioner) 
 
c. Have you had to retire early to care for the subject? 
o Yes 
 
 
o  No  Skip to question #8 
d. In case of yes, please specify:    
o I retired early at the age of___ years 
 

 
 
80
SOCIAL, FAMILY AND LEISURE TIME- RELATED PROBLEMS 
 
8. Have you had any family, social o leisure time-related problem 
for caring the subject in the last 3 months? 
o Yes 
 
 
o No  Skip to question #10 
 
9. In case of YES, please specify this(multiple choice option):: 
oI had to reduce my leisure time 
o I have conflicts with my partner or my family 
o I have no time to see or visit my friends 
o I have no time to take care of myself or other people 
o I have failed to start a family / I have not been able to have 
children (or more  children) 
 
Regarding the role played by you as PRINCIPAL CARER... 
 
10. How much time do you invest in a normal DAY for each one of the 
activities? 
Please specify the approximate time you spend daily on each activity 
On basic hygiene and dressing or changing them 
 
............... 
hours 
 
............... 
minutes          a day 
On bathing or showering them 
 
............... 
hours 
 
............... 
minutes          a day 
On feeding them 
 
............... 
hours 
 
............... 
minutes          a day 
On helping them to move around within the house 
 
............... 
hours 
 
............... 
minutes          a day 
On cooking and preparing meals 
 
............... 
hours 
 
............... 
minutes          a day 

 
 
81
Administration of drugs 
 
............... 
hours 
 
............... 
minutes          a day 
 
11. How much time do you invest in a normal WEEK on each one of the 
following activities? 
Please specify the approximate time you spend weekly on each activity 
On helping them to travel outside the house 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to contact health care suppliers 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to organise home adaptations 
 
............... 
hours 
 
............... 
minutes          a week 
On shopping 
 
............... 
hours 
 
............... 
minutes          a week 
On financial, administrative or legal affairs 
 
............... 
hours 
 
............... 
minutes          a week 
On social and leisure activities 
 
............... 
hours 
 
............... 
minutes          a week 
Monitoring and supervision (falls) 
 
............... 
hours 
 
............... 
minutes          a week 
 
 

 
 
82
 
Regarding the role played by OTHER CARERS (e.g. the rest of the family) 
12. How much time in a normal DAY do other carers spend on each one of 
the following activities? 
Please specify the approximate time these people spend daily on each activity 
On basic hygiene and dressing or changing them 
 
............... 
hours 
 
............... 
minutes          a day 
On bathing or showering them 
 
............... 
hours 
 
............... 
minutes          a day 
On feeding them 
 
............... 
hours 
 
............... 
minutes          a day 
On helping them to move around within the house 
 
............... 
hours 
 
............... 
minutes          a day 
On cooking and preparing meals 
 
............... 
hours 
 
............... 
minutes          a day 
Administration of drugs 
 
............... 
hours 
 
............... 
minutes          a day 
 
13. How much time do other carers spend in a normal WEEK on each of the 
following activities? 
Please specify the approximate time these people spend weekly on each activity 
On helping them to travel outside the house 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to contact health care suppliers 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to organise home adaptations 
 
............... 
hours 
 
............... 
minutes          a week 
On shopping 
 
............... 
hours 
 
............... 
minutes          a week 
On financial, administrative or legal affairs 
 
............... 
hours 
 
............... 
minutes          a week 
On social and leisure activities 
 
............... 
hours 
 
............... 
minutes          a week 

 
 
83
Monitoring and supervision (falls) 
 
............... 
hours 
 
............... 
minutes          a week 

 
 
84
 
QUESTIONNAIRE FOR THE CARER(week 52) 
The subject's principal informal carer (NOT CONTRACTED) fills in the questionnaire 
 
*If it is the first contact that the care has with the study because 
the person that she/he looks after did not need a carer before or it 
is a different carer, the carer must fill the baseline`s questionnaire. 
 
1. Identification number______________ 
 
HEALTH RELATED PROBLEMS 
 
2. Have you had any health-related problem for caring the subject 
in the last 6 months? 
o YES 
o NO  skip to question #4 
 
3.  In case of YES, please specify this(multiple choice option):: 
o I am depressed 
o I am in treatment because of caregiving 
o I am extremely tired 
o I have back pain 
o I have no problem of health because of caregiving 
 
WORK-RELATED PROBLEM 

 
 
85
 
4.  WHAT IS YOUR MAIN WORKING SITUATION? 
o I am employed 
o I am unemployed  
o Retired or pensioner  Skip to question #7 
o Domestic tasks  Skip to question #8 
o N/A  Skip to question #8 
 
5. Have you had any work-related problem for caring the subject in 
the last 6 months? 
o Yes 
 
 
o No  Skip to question #8 
 
6. In case of yes, please specify this 
o I requested___ days leave of absence 
o I was working ___ hours less a day for ___ days 
o I am working ___ hours less a day 
o I do not work less hours a day but I have problems fulfilling my 
working hours 
o I had to leave work because of illness the person I care 
o Other problems: _____________ 
 
7. Retirement (only to be answered in case the carer is retired or a 
pensioner) 
 
e. Have you had to retire early to care for the subject? 
o Yes 
 
 
 o  No  Skip to question #8 

 
 
86
f. 
In case of yes, please specify:    
o I retired early at the age of___ years 
 
SOCIAL, FAMILY AND LEISURE TIME- RELATED PROBLEMS 
 
8. Have you had any family, social o leisure time-related problem 
for caring the subject in the last 6 months? 
o Yes 
 
 
o No  Skip to question #10 
 
9. In case of YES, please specify this(multiple choice option): 
o I had to reduce my leisure time 
o I have conflicts with my partner or my family 
o I have no time to see or visit my friends 
o I have no time to take care of myself or other people 
o I have failed to start a family / I have not been able to have 
children (or more  children) 
 
 
Regarding the role played by you as PRINCIPAL CARER... 
 
10. How much time do you invest in a normal DAY for each one of the 
activities? 
Please specify the approximate time you spend daily on each activity 
On basic hygiene and dressing or changing them 
 
............... 
hours 
 
............... 
minutes          a day 
On bathing or showering them 
 
............... 
hours 
 
............... 
minutes          a day 

 
 
87
On feeding them 
 
............... 
hours 
 
............... 
minutes          a day 
On helping them to move around within the house 
 
............... 
hours 
 
............... 
minutes          a day 
On cooking and preparing meals 
 
............... 
hours 
 
............... 
minutes          a day 
Administration of drugs 
 
............... 
hours 
 
............... 
minutes          a day 
 
11. How much time do you invest in a normal WEEK on each one of the 
following activities? 
Please specify the approximate time you spend weekly on each activity 
On helping them to travel outside the house 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to contact health care suppliers 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to organise home adaptations 
 
............... 
hours 
 
............... 
minutes          a week 
On shopping 
 
............... 
hours 
 
............... 
minutes          a week 
On financial, administrative or legal affairs 
 
............... 
hours 
 
............... 
minutes          a week 
On social and leisure activities 
 
............... 
hours 
 
............... 
minutes          a week 
Monitoring and supervision (falls) 
 
............... 
hours 
 
............... 
minutes          a week 
 
 

 
 
88
 
Regarding the role played by OTHER CARERS (e.g. the rest of the family) 
12. How much time in a normal DAY do other carers spend on each one of 
the following activities? 
Please specify the approximate time these people spend daily on each activity 
On basic hygiene and dressing or changing them 
 
............... 
hours 
 
............... 
minutes          a day 
On bathing or showering them 
 
............... 
hours 
 
............... 
minutes          a day 
On feeding them 
 
............... 
hours 
 
............... 
minutes          a day 
On helping them to move around within the house 
 
............... 
hours 
 
............... 
minutes          a day 
On cooking and preparing meals 
 
............... 
hours 
 
............... 
minutes          a day 
Administration of drugs 
 
............... 
hours 
 
............... 
minutes          a day 
 
13. How much time do other carers spend in a normal WEEK on each of the 
following activities? 
Please specify the approximate time these people spend weekly on each activity 
On helping them to travel outside the house 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to contact health care suppliers 
 
............... 
hours 
 
............... 
minutes          a week 
On helping them to organise home adaptations 
 
............... 
hours 
 
............... 
minutes          a week 
On shopping 
 
............... 
hours 
 
............... 
minutes          a week 
On financial, administrative or legal affairs 
 
............... 
hours 
 
............... 
minutes          a week 
On social and leisure activities 
 
............... 
hours 
 
............... 
minutes          a week 

 
 
89
 
 
............... 
 
 
 

 
 
90
 
12. REFERENCES 
 
1. 
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, et al. Frailty in 
older adults: evidence for a phenotype. The journals of gerontology Series A, Biological 
sciences and medical sciences. 2001;56(3):M146-56. 
2. 
Ferrucci L, Cavazzini C, Corsi A, Bartali B, Russo CR, Lauretani F, et al. Biomarkers of 
frailty in older persons. Journal of endocrinological investigation. 2002;25(10 Suppl):10-5. 
3. 
Fried LP, Guralnik JM. Disability in older adults: evidence regarding significance, 
etiology, and risk. Journal of the American Geriatrics Society. 1997;45(1):92-100. 
4. 
Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among 
community-living older persons. Archives of internal medicine. 2006;166(4):418-23. 
5. 
Xue QL. The frailty syndrome: definition and natural history. Clinics in geriatric 
medicine. 2011;27(1):1-15. 
6. 
Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, et al. Effect of 
structured physical activity on prevention of major mobility disability in older adults: the LIFE 
study randomized clinical trial. Jama. 2014;311(23):2387-96. 
7. 
Gill TM, Gahbauer EA, Han L, Allore HG. Trajectories of disability in the last year of life. 
The New England journal of medicine. 2010;362(13):1173-80. 
8. 
Sourial N, Bergman H, Karunananthan S, Wolfson C, Payette H, Gutierrez-Robledo LM, 
et al. Implementing frailty into clinical practice: a cautionary tale. The journals of gerontology 
Series A, Biological sciences and medical sciences. 2013;68(12):1505-11. 
9. 
Bandeen-Roche K, Xue QL, Ferrucci L, Walston J, Guralnik JM, Chaves P, et al. 
Phenotype of frailty: characterization in the women's health and aging studies. The journals of 
gerontology Series A, Biological sciences and medical sciences. 2006;61(3):262-6. 
10. 
Garcia-Garcia FJ, Gutierrez Avila G, Alfaro-Acha A, Amor Andres MS, De Los Angeles De 
La Torre Lanza M, Escribano Aparicio MV, et al. The prevalence of frailty syndrome in an older 
population from Spain. The Toledo Study for Healthy Aging. The journal of nutrition, health & 
aging. 2011;15(10):852-6. 
11. 
Campbell AJ, Buchner DM. Unstable disability and the fluctuations of frailty. Age and 
ageing. 1997;26(4):315-8. 
12. 
Walston J, Fried LP. Frailty and the older man. The Medical clinics of North America. 
1999;83(5):1173-94. 
13. 
Rockwood K, Hogan DB, MacKnight C. Conceptualisation and measurement of frailty in 
elderly people. Drugs & aging. 2000;17(4):295-302. 
14. 
Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 
2013;381(9868):752-62. 
15. 
Strandberg TE, Pitkala KH. Frailty in elderly people. Lancet. 2007;369(9570):1328-9. 
16. 
Rodriguez-Artalejo F, Rodriguez-Manas L. The frailty syndrome in the public health 
agenda. Journal of epidemiology and community health. 2014;68(8):703-4. 
17. 
Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of 
multimorbidity and implications for health care, research, and medical education: a cross-
sectional study. Lancet. 2012;380(9836):37-43. 
18. 
Temple RM, Kirthi V, Patterson LJ. Is it time for a new kind of hospital physician? Bmj. 
2012;344:e2240. 
19. 
Stuck AE, Iliffe S. Comprehensive geriatric assessment for older adults. Bmj. 
2011;343:d6799. 

 
 
91
20. 
Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, et al. Frailty 
assessment in the cardiovascular care of older adults. Journal of the American College of 
Cardiology. 2014;63(8):747-62. 
21. 
Balducci L, Colloca G, Cesari M, Gambassi G. Assessment and treatment of elderly 
patients with cancer. Surgical oncology. 2010;19(3):117-23. 
22. 
Ellis G, Whitehead MA, Robinson D, O'Neill D, Langhorne P. Comprehensive geriatric 
assessment for older adults admitted to hospital: meta-analysis of randomised controlled 
trials. Bmj. 2011;343:d6553. 
23. 
Partridge JS, Harari D, Dhesi JK. Frailty in the older surgical patient: a review. Age and 
ageing. 2012;41(2):142-7. 
24. 
Philipps V, Amieva H, Andrieu S, Dufouil C, Berr C, Dartigues JF, et al. Normalized Mini-
Mental State Examination for assessing cognitive change in population-based brain aging 
studies. Neuroepidemiology. 2014;43(1):15-25. 
25. 
Morley JE. Developing novel therapeutic approaches to frailty. Current pharmaceutical 
design. 2009;15(29):3384-95. 
26. 
Mahoney FI, Barthel DW. Functional Evaluation: The Barthel Index. Maryland state 
medical journal. 1965;14:61-5. 
27. 
Yesavage JA. Geriatric Depression Scale. Psychopharmacology bulletin. 1988;24(4):709-
11. 
28. 
Sinclair AJ, Armes DG, Randhawa G, Bayer AJ. Caring for older adults with diabetes 
mellitus: characteristics of carers and their prime roles and responsibilities. Diabetic medicine : 
a journal of the British Diabetic Association. 2010;27(9):1055-9. 
29. 
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: 
the confusion assessment method. A new method for detection of delirium. Annals of internal 
medicine. 1990;113(12):941-8. 
30. 
Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, et al. A short 
physical performance battery assessing lower extremity function: association with self-
reported disability and prediction of mortality and nursing home admission. Journal of 
gerontology. 1994;49(2):M85-94. 
31. 
Schuit AJ, Schouten EG, Westerterp KR, Saris WH. Validity of the Physical Activity Scale 
for the Elderly (PASE): according to energy expenditure assessed by the doubly labeled water 
method. Journal of clinical epidemiology. 1997;50(5):541-6. 
32. 
Vellas B, Villars H, Abellan G, Soto ME, Rolland Y, Guigoz Y, et al. Overview of the MNA-
-Its history and challenges. The journal of nutrition, health & aging. 2006;10(6):456-63; 
discussion 63-5. 
33. 
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic 
comorbidity in longitudinal studies: development and validation. Journal of chronic diseases. 
1987;40(5):373-83. 
34. 
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating 
scales. Pain. 2011;152(10):2399-404. 
35. 
Bermejo F, Morales JM, Valerga C, del Ser T, Artolazabal J, Gabriel R. [A comparison 
between 2 abbreviated Spanish versions of mental status assessment in the diagnosis of 
dementia. Study data on elderly community residents]. Medicina clinica. 1999;112(9):330-4.