Trial Outcomes & Findings for Comprehensive Geriatric Assessment for Frail Older People (NCT NCT02773914)
NCT ID: NCT02773914
Last Updated: 2024-11-18
Results Overview
Changes in number of person dependent in one or more daily activity from baseline to follow-up. 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. At baseline, personal ADL (PADL: bathing, dressing, going to the toilet, transferring and feeding) was inquired for both actual PADL status during the hospital stay and retrospectively for PADL before onset of the acute illness leading to the hospital admission.
COMPLETED
NA
155 participants
1 year
2024-11-18
Participant Flow
Participant milestones
| Measure |
CGA Intervention
The CGA intervention will include multidisciplinary teams consisting of physician, nurse (RN), physiotherapist (PT), occupational therapist (OT) and social worker (SW). The team will work according to CGA, and have the primary and continuing responsibility for planning of hospital care and discharge. CGA will include assessment of socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, as well as treatment and planning for discharge and follow-up.
Comprehensive Geriatric Assessment: Comprehensive Geriatric Assessment intervention
|
Control Group
The control group receives usual hospital care, that is care given at an ordinary medical hospital ward, without the specialized multi-disciplinary team approach and CGA.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
40
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comprehensive Geriatric Assessment for Frail Older People
Baseline characteristics by cohort
| Measure |
CGA Intervention
n=78 Participants
The CGA intervention will include multidisciplinary teams consisting of physician, nurse (RN), physiotherapist (PT), occupational therapist (OT) and social worker (SW). The team will work according to CGA, and have the primary and continuing responsibility for planning of hospital care and discharge. CGA will include assessment of socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, as well as treatment and planning for discharge and follow-up.
Comprehensive Geriatric Assessment: Comprehensive Geriatric Assessment intervention
|
Control Group
n=77 Participants
The control group receives usual hospital care, that is care given at an ordinary medical hospital ward, without the specialized multi-disciplinary team approach and CGA.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearChanges in number of person dependent in one or more daily activity from baseline to follow-up. 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. At baseline, personal ADL (PADL: bathing, dressing, going to the toilet, transferring and feeding) was inquired for both actual PADL status during the hospital stay and retrospectively for PADL before onset of the acute illness leading to the hospital admission.
Outcome measures
| Measure |
CGA Intervention
n=78 Participants
The CGA intervention will include multidisciplinary teams consisting of physician, nurse (RN), physiotherapist (PT), occupational therapist (OT) and social worker (SW). The team will work according to CGA, and have the primary and continuing responsibility for planning of hospital care and discharge. CGA will include assessment of socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, as well as treatment and planning for discharge and follow-up.
Comprehensive Geriatric Assessment: Comprehensive Geriatric Assessment intervention
|
Control Group
n=77 Participants
The control group receives usual hospital care, that is care given at an ordinary medical hospital ward, without the specialized multi-disciplinary team approach and CGA.
|
|---|---|---|
|
Dependence in Activities of Daily Living
|
78 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: 1 yearChanges in number of person with good self-rated health from baseline to follow-up. Self-rated health 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month follow-upSatisfaction of care scored on a five answer statements using a likert-scale. 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearLife 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.
Outcome measures
Outcome data not reported
Adverse Events
CGA Intervention
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place