NCT02618291

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
429

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

November 24, 2015

Last Update Submit

February 18, 2021

Conditions

Keywords

primary health care

Outcome Measures

Primary Outcomes (2)

  • Instrumental Activities of Daily Living (IADL)

    Proportion of patients losing at least 1 instrumental IADL (8 items developed to assess functional status)

    2 years

  • Basic Activities of Daily Living (ADL)

    Proportion of patients losing at least 1 basic ADL (6 items developed to assess functional status)

    2 years

Secondary Outcomes (5)

  • Incidence of hospital admissions

    During 2 years

  • Incidence of institutionalization

    During 2 years

  • Incidence of emergency visits

    During 2 years

  • Incidence of outpatient visits

    During 2 years

  • Health related quality of life (WHOQOL-OLD) score

    2 years

Other Outcomes (2)

  • Adhesion to Active Geriatric Evaluation Tool

    2 years

  • Total cost

    2 years

Study Arms (2)

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.

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.

Other: Usual care

Interventions

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.

Also known as: Active geriatric evaluation
Active Geriatric Evaluation (AGE tool)

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.

Usual care

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ambulatory Care and Community Medicine

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • 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 Officials

  • Nicolas Senn, MD PhD

    Department of community medicine and ambulatory care, University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research and de development centre

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 1, 2015

Study Start

June 1, 2016

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations