- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02618291
Efficacy of an Active Geriatric Evaluation for Geriatric Syndromes to Prevent Functional Decline in Family Medicine (AGE3)
Efficacy of a an Active Geriatric Evaluation (AGE Tool) for Geriatric Syndromes to Prevent Functional Decline in Elderly Patients in Family Medicine: a Pragmatic Cluster Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The ageing of the population is associated to a rapid increase of chronic conditions and more specifically geriatric syndromes for which the health care system is largely unprepared. Being in frontline of this huge arising burden, family practitioners (FP) will need adapted tools to identify and manage elderly patients with complex needs and prevent functional decline while improving quality of life. It is however well recognized that effective and efficient evidence-based interventions adapted to the primary care setting are lacking. The AGE program (Active Geriatric Evaluation) was launched in 2011 and aimed at developing a comprehensive assessment and management tool for FP's to better identify and manage geriatric syndromes. The AGE tool consists of a 20-minute clinical screening instrument (Brief Assessment Tool, BAT), which performances for identifying geriatric syndromes was already assessed in general practice along the AGE program, and a comprehensive approach that encompasses: complementary diagnostic evaluations and propositions of management & treatment for each syndrome. The efficacy and efficiency of the AGE tool for preventing functional decline was never assessed in real life settings of general practice.
The aim of the study is to determine whether a comprehensive tool combining a brief assessment tool (BAT) for the early diagnosis of geriatric syndromes with a structured diagnostic and management strategy impacts on the functional decline and quality of life of elderly patients.
Design: Two-arm open label cluster randomized trial in FP practices, randomization unit: FP
Participants and setting: FP's and their patients aged ≥ 75 years in the French part of Switzerland. In total: 40 FP's (2x20) and 400 patients (2 x 200)
Intervention: Active Geriatric Evaluation. Controls: Usual care provided by FP's. Duration of study: 3 years (2 years of follow-up). Expected outcomes:functional ability of patients in the intervention arm ,measured through the activities of daily living, will be conserved compared to patients in the usual care arm.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Vaud
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Lausanne, Vaud, Switzerland, 1011
- Department of Ambulatory Care and Community Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 75 years or more
- Consider the enrolling physician as his/her reference FP
- Able to understand French
- Living at home (not in institutions)
- Visited his/her FP at least twice during the past year
- Giving signed informed consent (or, in the absence of discerning capacity, giving assent in the presence of a surrogate signing the consent form)
Exclusion Criteria:
- Having had a geriatric or specialized memory consultation in the past 3 months (including assessment during rehabilitation)
- Planning to leave the study area or to change of FP in the next 2 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Geriatric Evaluation (AGE tool)
The Active Geriatric Evaluation is a comprehensive assessment and management tool consisting of a 20-minute clinical screening instrument (Brief Assessment Tool, BAT) to identify 8 geriatric syndromes, and complementary diagnostic evaluations and propositions of management & treatment for each syndrome.
|
Yearly administration of the brief assessment tool (BAT).
Once the presence of one or more geriatric syndromes is suspected using the brief assessment tool, a management strategy is proposed.
It is divided in two distinct steps: 1) perform additional tests to confirm or exclude the diagnosis and 2) to propose specific management attitudes.
All proposed attitudes are based on literature review and geriatrician expertise.
The FP remains free to follow the proposed attitudes.
Other Names:
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Active Comparator: Usual care
No specific intervention will be provided to the patients, except what family practitioners (FPs) usually do.
In this regard, it is possible that some FPs might use structured interventions similar to the AGE tool.
This will be neither encouraged nor discouraged.
FPs in the "usual care" arm will be asked to perform one BAT after 2 years of follow-up, at the final patient visit.
|
No specific intervention will be provided to the patients, except what family practitioners (FPs) usually do.
In this regard, it is possible that some FPs might use structured interventions similar to the AGE tool.
This will be neither encouraged nor discouraged.
FPs in the "usual care" arm will be asked to perform one BAT after 2 years of follow-up, at the final patient visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Instrumental Activities of Daily Living (IADL)
Time Frame: 2 years
|
Proportion of patients losing at least 1 instrumental IADL (8 items developed to assess functional status)
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2 years
|
Basic Activities of Daily Living (ADL)
Time Frame: 2 years
|
Proportion of patients losing at least 1 basic ADL (6 items developed to assess functional status)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of hospital admissions
Time Frame: During 2 years
|
Number of hospital admissions per patient per year
|
During 2 years
|
Incidence of institutionalization
Time Frame: During 2 years
|
Number of institutionalization per patient per year
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During 2 years
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Incidence of emergency visits
Time Frame: During 2 years
|
Number of emergency visits per patient per year
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During 2 years
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Incidence of outpatient visits
Time Frame: During 2 years
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Number of outpatient visits to GP per patient per year
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During 2 years
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Health related quality of life (WHOQOL-OLD) score
Time Frame: 2 years
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questionnaire composed of 24 items.
This broadly validated instrument is composed of six facets: 1) Sensory abilities, 2) Autonomy, 3) Past, present and future activities, 4) Social participation, 5) Death and dying and 6) Intimacy
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2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adhesion to Active Geriatric Evaluation Tool
Time Frame: 2 years
|
Proportion of GPs completing the difference sections of the Active Geriatric Evaluation Tool
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2 years
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Total cost
Time Frame: 2 years
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Comparison, by arm, of total cost, corresponding to the sum of costs billed by FPs, drug prescriptions, hospital and institutional admission costs
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2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicolas Senn, MD PhD, Department of community medicine and ambulatory care, University of Lausanne
Publications and helpful links
General Publications
- Mueller Y, Schwarz J, Monod S, Locatelli I, Senn N. Use of standardized brief geriatric evaluation compared with routine care in general practice for preventing functional decline: a pragmatic cluster-randomized trial. CMAJ. 2021 Aug 23;193(33):E1289-E1299. doi: 10.1503/cmaj.202887.
- Schnegg D, Senn N, Bugnon O, Schwarz J, Mueller Y. Drug Prescription in Older Swiss Men and Women Followed in Family Medicine. Drugs Real World Outcomes. 2020 Mar;7(1):87-95. doi: 10.1007/s40801-019-00175-6.
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32003B_159863/1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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