DependencyNCT02773914
Comprehensive Geriatric Assessment for Frail Older People
A study testing Comprehensive Geriatric Assessment in people with Dependency, run by Göteborg University at 1 site in Sweden.
Trial summary
The study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" comprised two study arms: one intervention and one control group. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Dependency
- What is being tested?
- Comprehensive Geriatric Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to 27 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All patients 75 years and older seeking acute hospital care at the hospital emergency department will be screened for frailty.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings: A Randomized Controlled Study
The study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" comprised two study arms: one intervention and one control group. The aim of the study was to evaluate the effects of the Comprehensive Geriatric Assessment (CGA) for frail older people in Swedish acute hospital settings - the CGA-Swed study. The intervention group received the CGA and a control group received medical assessment without the CGA. Follow-ups were conducted after 1, 6 and 12 months, with dependence in activities of daily living (ADL) as the primary outcome measure. The study group consisted of frail older people, 75 years and older, in need of acute medical hospital care. The study design, randomization and process evaluation carried out were intended to ensure the quality of the study. Baseline data showed that the randomisation was successful and that the sample included frail older people with high dependence in ADL, and with a high comorbidity. Thus, the CGA contributed to early recognition of frail older people's needs and ensured a care plan and follow-up. When investigating the long-term effects on frail older people's ADL 12 months after receiving the CGA, 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. Qualitative interviews with CGA-participants also showed that the participants felt respected as a person when receiving care on a CGA acute geriatric ward.
Read the 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.
- Conditions
- Dependency
- Being tested
- Comprehensive Geriatric Assessment
- Keywords
- Activity of Daily Living (ADL), Comprehensive Geriatric Assessment, Elderly, Frailty, Randomized controlled study
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
Comprehensive Geriatric Assessment intervention
| Study group | Role | What they receive |
|---|---|---|
| CGA intervention | Experimental | 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. Receives: Other: Comprehensive Geriatric Assessment |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependence in Activities of Daily Living
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.
Measured: 1 year
Secondary outcomes (3)
Self-rated Health
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.
Measured: 1 year
Satisfaction With Quality of Care
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
Measured: 1 month follow-up
Life Satisfaction
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMar 2016
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DependencyStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Sponsor
- Investigators
- Isabelle Andersson Hammar, Assoc.prof, Principal investigator, Göteborg UniversityKatarina Wilhelmson, Professor, Study director, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773914
- Sponsor's protocol ID
- CGA for frail older people
- Status last verified
- Sep 2024
- First submitted
- 9 May 2016
- Last updated
- 18 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 38172750Westgard 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.
PubMed 35931975Wilhelmson 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.
PubMed 35240988Wilhelmson 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.
PubMed 31991598Westgard 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.
PubMed 33291834Westgard 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.
PubMed 31023984Westgard 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.
PubMed 29423259
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02773914
- Acronym / sponsor ID
- CGA for frail older people
- Conditions
- Dependency
- Keywords
- Activity of Daily Living (ADL), Comprehensive Geriatric Assessment, Elderly, Frailty, Randomized controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- Mar 2016 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Posted 18 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" comprised two study arms: one intervention and one control group. The aim of the study was to evaluate the effects of the Comprehensive Geriatric Assessment (CGA) for frail older people in Swedish acute hospital settings - the CGA-Swed study. The intervention group received the CGA and a control group received medical assessment without the CGA. Follow-ups were conducted after 1, 6 and 12 months, with dependence in activities of daily living (ADL) as the primary outcome measure. The study group consisted of frail older people, 75 years and older, in need of acute medical hospital care. The study design, randomization and process evaluation carried out were intended to ensure the quality of the study. Baseline data showed that the randomisation was successful and that the sample included frail older people with high dependence in ADL, and with a high comorbidity. Thus, the CGA contributed to early recognition of frail older people's needs and ensured a care plan and follow-up. When investigating the long-term effects on frail older people's ADL 12 months after receiving the CGA, 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. Qualitative interviews with CGA-participants also showed that the participants felt respected as a person when receiving care on a CGA acute geriatric ward.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGA intervention | Experimental | Other: Comprehensive Geriatric AssessmentThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All patients 75 years and older seeking acute hospital care at the hospital emergency department will be screened for frailty.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentComprehensive Geriatric Assessment intervention | Other | CGA intervention |
Primary outcome
Dependence in Activities of Daily Living
Time frame: 1 year
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.
3 secondary outcomes
Self-rated Health
Time frame: 1 year
Satisfaction With Quality of Care
Time frame: 1 month follow-up
Life Satisfaction
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38172750Andersson 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.
- Results publication: PubMed 35931975Westgard 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.
- Results publication: PubMed 35240988Wilhelmson 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.
- Results publication: PubMed 31991598Wilhelmson 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.
- Results publication: PubMed 33291834Westgard 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.
- Results publication: PubMed 31023984Westgard 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.
- Results publication: PubMed 29423259Westgard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Andersson Hammar, Assoc.prof principal investigator
Göteborg University
Katarina Wilhelmson, Professor study director
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Geriatric Assessment in people with Dependency, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dependence in Activities of Daily Living (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02773914, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.