Geriatric SyndromeAGE3NCT02618291
Efficacy of an Active Geriatric Evaluation for Geriatric Syndromes to Prevent Functional Decline in Family Medicine
A study testing Active Geriatric Evaluation (AGE tool) in people with Geriatric Syndrome and Functional Ability, run by University of Lausanne at 1 site in Switzerland.
Trial summary
This study aims to test the efficacy of a comprehensive assessment and management tool (AGE: Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in elderly patients followed in family medicine. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Syndrome, Functional Ability
- What is being tested?
- Active Geriatric Evaluation (AGE tool)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ambulatory Care and Community Medicine
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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
This study aims to test the efficacy of a comprehensive assessment and management tool (AGE: Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in elderly patients followed in family medicine. Family practitioners will be randomised either to the intervention, consisting of a yearly screening for eight geriatric syndromes accompanied by a management plan in case of positive screening, or to usual care. Level of functioning and quality of life of patients in both arms will be assessed over two years.
Read the 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.
- Conditions
- Geriatric Syndrome, Functional Ability
- Being tested
- Active Geriatric Evaluation (AGE tool), Usual care
- Keywords
- primary health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Geriatric Evaluation (AGE tool)Other
Also called Active geriatric evaluation
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Geriatric Evaluation (AGE tool) | Experimental | 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. Receives: Other: Active Geriatric Evaluation (AGE tool) |
| Usual care | Active comparator | 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental Activities of Daily Living (IADL)
Proportion of patients losing at least 1 instrumental IADL (8 items developed to assess functional status)
Measured: 2 years
Basic Activities of Daily Living (ADL)
Proportion of patients losing at least 1 basic ADL (6 items developed to assess functional status)
Measured: 2 years
Secondary outcomes (5)
Incidence of hospital admissions
Number of hospital admissions per patient per year
Measured: During 2 years
Incidence of institutionalization
Number of institutionalization per patient per year
Measured: During 2 years
Incidence of emergency visits
Number of emergency visits per patient per year
Measured: During 2 years
Incidence of outpatient visits
Number of outpatient visits to GP per patient per year
Measured: During 2 years
Health related quality of life (WHOQOL-OLD) score
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJun 2016
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Geriatric SyndromeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Senn, University of Lausanne
- Investigators
- Nicolas Senn, MD PhD, Principal investigator, Department of community medicine and ambulatory care, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618291
- Sponsor's protocol ID
- 32003B_159863/1
- Acronym
- AGE3
- Status last verified
- Feb 2021
- First submitted
- 24 Nov 2015
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34426445Schnegg 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.
PubMed 31845213
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02618291
- Acronym / sponsor ID
- AGE3 / 32003B_159863/1
- Conditions
- Geriatric Syndrome, Functional Ability
- Keywords
- primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the efficacy of a comprehensive assessment and management tool (AGE: Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in elderly patients followed in family medicine. Family practitioners will be randomised either to the intervention, consisting of a yearly screening for eight geriatric syndromes accompanied by a management plan in case of positive screening, or to usual care. Level of functioning and quality of life of patients in both arms will be assessed over two years.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Geriatric Evaluation (AGE tool) | Experimental | Other: 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. |
| Usual care | Active comparator | Other: Usual careNo 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Active Geriatric Evaluation (AGE tool)Also: Active geriatric evaluationYearly 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 | Active Geriatric Evaluation (AGE tool) |
| Usual careNo 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. | Other | Usual care |
Primary outcome
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)
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)
5 secondary outcomes
Incidence of hospital admissions
Time frame: During 2 years
Incidence of institutionalization
Time frame: During 2 years
Incidence of emergency visits
Time frame: During 2 years
Incidence of outpatient visits
Time frame: During 2 years
Health related quality of life (WHOQOL-OLD) score
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 34426445Mueller 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.
- Derived from this study: PubMed 31845213Schnegg 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.
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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.
Nicolas Senn, MD PhD principal investigator
Department of community medicine and ambulatory care, University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Geriatric Evaluation (AGE tool) in people with Geriatric Syndrome and Functional Ability, run by University of Lausanne at 1 site in Switzerland.
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 6 inclusion and 2 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 21 Feb 2021. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Instrumental Activities of Daily Living (IADL) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02618291, which also lists 2 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 21 Feb 2021.