Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings: A Randomized Controlled Study
Phase: NA
Conditions: Dependency
Sponsor: Göteborg University

 
Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute 
Care Settings (CGA-Swed):  
A Randomised Controlled Study 
 
 
NCT02773914 
 
2024-09-10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol with SAP and/or ICF 
 
Aim 
The aim of the study was to evaluate the effects of the CGA for frail older people in Swedish acute 
hospital settings. The study addressed the following research questions: 
Can the Comprehensive Geriatric Assessment for frail older people in Swedish acute hospital settings: 
1. Maintain independence in activities of daily living, functional status, health-related quality of 
life and life satisfaction? 
2. Increase satisfaction with health care? 
3. Reduce hospital and primary health care consumption? 
How feasible and acceptable are the study processes and procedures of the CGA from the perspective 
of care givers and older persons in Swedish settings? 
 
Material and methods  
The study was a two-armed randomised controlled trial that started with a pilot study in 2016. Ethical 
approval was obtained for the study, ref. no: 4,899-15, Regional Ethical Review Board in Gothenburg. 
Trial Registration: ClinicalTrials.gov, NCT02773914. 
 
Data collection and participants: The study group included 155 older people who sought acute 
medical care at the emergency department during the period between March 2016 and December 
2018. Inclusion criteria were that participants were to be ≥75 years of age, in need of acute in-
hospital care and screened as frail according to the FRESH-screening instrument. Exclusion criteria 
were not being screened as frail according to the FRESH-screening instrument, being admitted 
through a “fast track” for direct admission to a designated ward (for predefined diagnosis such as 
stroke, acute myocardial infarction and hip fracture) and having an acute severe condition requiring a 
higher level of care (e.g., intensive care) than the intervention ward. Baseline measures were 
collected by a research assistant who gathered data from the frail older patient and/or from the 
medical records during the hospital stay. Follow-up interviews were performed in the older person’s 
home at 1, 6 and 12 months after hospital discharge. The follow-ups were performed using a 
structured questionnaire including questions about demographic data and assessments of outcome 
measures. The interviews lasted for approximately 1.5 h. 
 
Intervention/control group: The intervention was the ward working according to the Comprehensive 
Geriatric Assessment. Key components of the CGA are multi-disciplinary teamwork, use of a person-
centred approach, comprehensive assessments, treatment and rehabilitation, discharge planning and 
follow-up. The multi-disciplinary team consisted of a physician, registered nurse (RN), assistant nurse 
(AN), physiotherapist (PT) and occupational therapist (OT) as well as other team members, such as a 
social worker (SW) and dietician, if needed. The control group received the usual acute hospital care, 
i.e., care given at an ordinary medical hospital ward without a specialised multi-disciplinary team 
approach and without the CGA. The assessments and care provided at the control wards were based 
on the acute problem/symptom that the patients had and did not include the comprehensive and 
person-centred approach to the health and life situation of the patient inherent in a CGA.  
 
Measurements: Dependence in daily activities was measured using the ADL-staircase assessment by 
combining both interviews and observations. It includes dependence in nine activities: cleaning, 
shopping, transportation, cooking, bathing, dressing, going to the toilet, transferring and feeding. 
Dependence was defined as a state in which another person is involved in the activity by giving 
personal or directive assistance. The sum of dependence in the nine activities of daily living is 
calculated, range 0–9, with a clinically significant change of ≥1 unit between baseline and follow-up.  
Functional status was measured using the Timed Up and Go (TUG) test, the Berg 
Balance Scale, Gait Speed four-metre walking test and Grip Strength with North Coast Dynamometer. 
The TUG test measures the time for a person to rise from a chair, walk 3 m, turn around, walk back, 

and sit down again. It measures both static and dynamic balance. In this study, we defined a change 
of ≥4 s as a clinically significant difference between baseline and follow-up, with 3.6 s considered as 
the minimal detectable change for TUG test measurements. For details on Berg Balance Scale, Gait 
Speed and Grip Strength, Cognition was measured using the Mini Mental State Examination. 
Self-rated was measured by the question: “In general, would you say your health is”, with the 
response alternatives: excellent, very good, good, fair, and poor. Clinically significant difference was 
defined as ≥1 step in the response alternatives between baseline and follow-up. In addition, self-
reported symptoms were measured using the Göteborg Quality of Life Instrument. 
Life satisfaction was measured using the Fugl–Meyer–Lisat-11 Questionnaire which 
includes 11 items concerning satisfaction with: life as a whole, work, financial situation, leisure, 
friends and acquaintances, sexual life, functional capacity, family life, partner relationship, physical 
health and psychological health. Response alternatives included: very dissatisfied, dissatisfied, rather 
dissatisfied, rather satisfied, satisfied and very satisfied. In the analysis, the responses to each 
question were dichotomised into satisfied (very satisfied and satisfied) or not satisfied (rather 
satisfied, rather dissatisfied, dissatisfied and very dissatisfied) as was done in the validation of the 
questionnaire. The sum of items for which the respondent reported being satisfied were calculated, 
range 0–11, with a clinically significant change of ≥1 between baseline and follow-up. 
Satisfaction with quality of care was measured by the participant’s agreement with six statements 
with a person-centred approach: “I feel that the care given during the hospital stay meets my needs”, 
“I feel that the care planning meeting before discharge was valuable”, “I was able to take part in the 
discussion of my needs in the care planning meeting”, “I feel that the actions planned equal my 
needs”, “I feel that the actions delivered equal my needs” and “I am satisfied with the hospital care”. 
The response alternatives were agree completely, agree partly, neither agree nor disagree, disagree, 
and disagree completely. An answer of agree completely or agree partly were considered as satisfied. 
These questions were only measured once (at 1 month follow-up) and were used as the difference 
between intervention and control groups in the proportion of participants being satisfied for each 
question at follow-up as has been done previously. In this study, we used the following 
measurements and cut-off levels of frailty indicators: Weakness: Reduced grip strength considered to 
be below lowest norm range for ages 80–84, 13 kg for women and 21 kg for men for the right hand 
and below 10 kg for women and 18 kg for men for the left hand, using a North Coast dynamometer. 
Fatigue: Question from the Göteborg Quality of Life Instrument, answering “Yes” to the question 
“Have you suffered any general fatigue/tiredness over the last three months?” 
Weight loss: Question from the Göteborg Quality of Life Instrument, answering “Yes” to the question 
“Have you suffered any weight loss over the last three months?” 
Reduced physical activity: Taking 1–2 or less outdoor walks per week. 
Impaired balance: The Berg Balance Scale, reduced balance defined as having a value of 47 or less. 
Reduced gait speed: Walking four metres with a gait speed of 0.6 metres/second or slower. 
Visual impairment: The KM chart (Konstantin Moutakis chart), impaired vision defined as having a 
visual acuity of 0.5 or less. 
Impaired cognition: The MMSE, impaired cognition defined as having a score below 25. 
 
Statistical analysis 
A power calculation was done based on the primary outcome variable, dependence in activities of 
daily living (range 0–9) with an assumed difference between the intervention and control groups of 
one dependence (i.e., dependent in one or more activities of daily living, a clinically relevant 
difference of importance to the individual as well as the caregiver) and a standard deviation of 2 in 
both groups. To detect a difference between the intervention and control groups with a two-sided 
test and with a significance level of α = 0.05 and 80% power, at least 64 participants were needed in 
each group. To take a potential loss to follow-up into account, a total of 150 persons (75 in the control 
group and 75 in the intervention group) were initially planned to be included. This was later revised 
to allow for a higher loss to follow-up (22%) with 78 + 78, equalling a total of 156 participants.  
 

Both descriptive and analytical statistics were used in order to compare groups and to analyse 
changes over time. Non-parametric statistics were used when ordinal data were analysed. Otherwise, 
parametric statistics were used. Besides descriptive statistics, the chi2 and Fisher’s two-tailed exact 
tests to test differences in the proportions among the groups were used. A value of p ≤ 0.05 (two-
tailed) were considered significant. The analysis were made on the basis of the intention-to-treat 
principle, meaning that participants were analysed on the basis of the group to which they were 
initially randomised. The approach of data imputation was the replacement of missing values with a 
value based on the median change of deterioration between baseline and follow-up of all who 
participated in the follow-up.