NCT03161860

Brief Summary

Global aging and the growing burden of chronic diseases represent a challenge. Innovative interventions acting upon health determinants, like social participation, are required. Social participation, defined as the involvement of a person in activities that provide interactions with others in the community is critical to promote health and prevent disabilities. Many older adults do not have equitable opportunities to achieve full social participation, and interventions under-empower their personal and environmental resources and only reach a minority. To optimize current practices, the Personalised citizen assistance for social participation (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation. The first aim of this study is evaluate the impacts of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation. The second aim is to evaluate the cost-effectiveness of the intervention. In parallel, the implementation of the APIC, including factors facilitating and impeding it, will be documented. Concerning the first two objectives, two hypotheses are formulated: 1) the APIC will prevent a decline in older women's and men's health, social participation and life satisfaction, and reduce their use of healthcare services, and 2) the APIC will be associated with lower costs, from older adults', healthcare system and societal perspectives, including healthcare expenditures.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 4, 2017

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 28, 2025

Status Verified

December 1, 2024

Enrollment Period

7.8 years

First QC Date

May 17, 2017

Last Update Submit

March 24, 2025

Conditions

Keywords

Program evaluationCost-effectivenessCommunity participationempowerment

Outcome Measures

Primary Outcomes (1)

  • v2 of the 36-Item Short-Form Health Survey (SF-36) (''change'' is is being assessed)

    Physical and mental health

    Baseline, 12, 18, 24 months

Secondary Outcomes (3)

  • Social participation scale

    Baseline, 12, 18, 24 months

  • Life Satisfaction Index-Z

    Baseline, 12, 18, 24 months

  • Use of healthcare services-Standardized questionnaire

    every two months over a 2-year period

Study Arms (2)

Personalised citizen assistance

EXPERIMENTAL

The experimental group will receive the Personalised citizen assistance for social participation (APIC), i.e. weekly 3-hour personalised stimulation sessions by a trained volunteer over 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources, and community integration.

Behavioral: Personalised citizen assistance for social participation(APIC)

Control group

NO INTERVENTION

The control group will receive the publicly-funded universal healthcare services available to all Quebecers.

Interventions

The APIC involves a non-professional attendant who, after 2 to 5 days of training, provides a two to three-hour stimulation session each week over a six to eighteen-month period targeting significant social and leisure activities that are otherwise difficult for older adults to accomplish.

Personalised citizen assistance

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • be aged 65 or older,
  • live at home or in seniors' residences,
  • be restricted in at least one instrumental activity of daily living (e.g. house cleaning, shopping), and
  • have a good understanding of French or English.

You may not qualify if:

  • Moderate to severe cognitive impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre d'action bénévole Drummond

Drummondville, Quebec, J2C 3W1, Canada

Location

Centre d'action bénévole Bellechasse-Lévis-Lotbinière

Lévis, Quebec, G6V 1N6, Canada

Location

Service d'aide et de référencement Anjou (SARA-Anjou)

Montreal, Quebec, H1K 4J4, Canada

Location

Carrefour communautaire Montrose

Montreal, Quebec, H1X 2X2, Canada

Location

Centre ABC

Montreal, Quebec, H4L 3Y6, Canada

Location

Accorderie de Sherbrooke, coopérative de solidarité

Sherbrooke, Quebec, J1H 5N6, Canada

Location

Related Publications (2)

  • Levasseur M, Chaintre-Prieur A, Dubois MF, Maisonneuve C, Filiatrault J, Vassiliadis HM. Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial. Trials. 2024 Jun 27;25(1):415. doi: 10.1186/s13063-024-08248-w.

  • Levasseur M, Dubois MF, Filliatrault J, Vasiliadis HM, Lacasse-Bedard J, Tourigny A, Levert MJ, Gabaude C, Lefebvre H, Berger V, Eymard C. Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT). BMJ Open. 2018 Mar 31;8(3):e018676. doi: 10.1136/bmjopen-2017-018676.

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Mélanie Levasseur

    Université de Sherbrooke; Research centre on aging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the type of intervention, coordinators, volunteers and participants will not be blinded to the interventions. However, they will not be informed about the study hypotheses. Research assistants and the statistician responsible for the analysis will be blinded to the intervention until completion of the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 22, 2017

Study Start

October 4, 2017

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

March 28, 2025

Record last verified: 2024-12

Locations