- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02773914
Comprehensive Geriatric Assessment for Frail Older People
Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" was to evaluate the effects of the Comprehensive Geriatric Assessment (CGA) for frail older people in Swedish acute hospital settings.
The study addressed the following research questions:
Can Comprehensive Geriatric Assessment for frail older patients in Swedish acute hospital settings:
- increase/maintain independence, functional status, health related quality of life and life satisfaction?
- increase satisfaction with health care?
- reduce health care consumption?
- How feasible and acceptable are the study processes and procedures of CGA from the perspective of care givers and older persons in Swedish settings?
The intervention addressed people 75 years and older who were seeking acute hospital care at the hospital emergency department, and who were identified as being frail. The CGA intervention included a multidisciplinary team that assessed the patient's 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. The intervention was person-centred, and comprised a comprehensive assessment tailored for each person.
In total, one-hundred and fifty-five people participated in the study; 78 in the intervention group and 77 in the control group. Participants in the intervention group had a higher odds ratio of reporting having received written information and felt that care met their needs during their hospital stay. At the 12-month follow up, 78 people participated (40 in the control and 38 in the intervention). Results showed that twelve participants in the intervention group (15.4%), and four participants in the control group (5.2%) had improved in their ADL 1 year after discharge. Further, people who received the CGA intervention had higher odds of receiving antidepressant treatment, suggesting that CGA improves recognition of mental health needs during an unplanned hospital admission. Qualitative interviews with participants receiving the CGA showed that the care they received on the CGA ward met their needs. The participants felt respected as a person when receiving care on a CGA acute geriatric ward. This was achieved by having a reciprocal relationship with the ward staff, enabling their participation in decisions when engaged in communication and understanding.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Gothenburg, Sweden
- Isabelle Andersson Hammar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients 75 years and older seeking acute hospital care at the hospital emergency department will be screened for frailty.
Exclusion Criteria:
- Those with symptoms of predefined diagnoses such as stroke, acute myocardial infarction and hip fractures, admitted through "fast tracks" directly to a designated ward without passing the emergency department.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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Comprehensive Geriatric Assessment intervention
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No 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dependence in Activities of Daily Living
Time Frame: 1 year
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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. |
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-rated Health
Time Frame: 1 year
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Changes 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. |
1 year
|
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Satisfaction With Quality of Care
Time Frame: 1 month follow-up
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Satisfaction 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
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1 month follow-up
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Life Satisfaction
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Isabelle Andersson Hammar, Assoc.prof, Göteborg University
- Study Director: Katarina Wilhelmson, Professor, Göteborg University
Publications and helpful links
General Publications
- Andersson Hammar I, Westgard T, Dahlin-Ivanoff S, Wilhelmson K. Frail older people with decreased cognition can perceive reduced self-determination in self-care and social relationships. BMC Geriatr. 2024 Jan 3;24(1):7. doi: 10.1186/s12877-023-04492-y.
- Westgard T, Hammar IA, Wilhelmson K, Waern M. Comprehensive geriatric assessment is associated with increased antidepressant treatment in frail older people with unplanned hospital admissions-results from the randomised controlled study CGA-Swed. BMC Geriatr. 2022 Aug 5;22(1):645. doi: 10.1186/s12877-022-03324-9.
- Wilhelmson K, Andersson Hammar I, Westgard T, Holmquist Henrikson L, Dahlin-Ivanoff S. Positive effects on activities of daily living one year after receiving comprehensive geriatric assessment - results from the randomised controlled study CGA-Swed. BMC Geriatr. 2022 Mar 3;22(1):180. doi: 10.1186/s12877-022-02862-6.
- Wilhelmson K, Hammar IA, Ehrenberg A, Niklasson J, Eckerblad J, Ekerstad N, Westgard T, Holmgren E, Aberg ND, Ivanoff SD. Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings (CGA-Swed): A Randomised Controlled Study. Geriatrics (Basel). 2020 Jan 24;5(1):5. doi: 10.3390/geriatrics5010005.
- Westgard T, Andersson Hammar I, Dahlin-Ivanoff S, Wilhelmson K. Can Comprehensive Geriatric Assessment Meet Frail Older People's Needs? Results from the Randomized Controlled Study CGA-Swed. Geriatrics (Basel). 2020 Dec 4;5(4):101. doi: 10.3390/geriatrics5040101.
- Westgard T, Wilhelmson K, Dahlin-Ivanoff S, Ottenvall Hammar I. Feeling Respected as a Person: a Qualitative Analysis of Frail Older People's Experiences on an Acute Geriatric Ward Practicing a Comprehensive Geriatric Assessment. Geriatrics (Basel). 2019 Jan 25;4(1):16. doi: 10.3390/geriatrics4010016.
- Westgard T, Ottenvall Hammar I, Holmgren E, Ehrenberg A, Wisten A, Ekdahl AW, Dahlin-Ivanoff S, Wilhelmson K. Comprehensive geriatric assessment pilot of a randomized control study in a Swedish acute hospital: a feasibility study. Pilot Feasibility Stud. 2018 Jan 29;4:41. doi: 10.1186/s40814-018-0228-1. eCollection 2018.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CGA for frail older people
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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