Effect of Personalised Citizen Assistance for Social Participation(APIC) on Older Adults Health and Social Participation (APIC)

May 10, 2023 updated by: Mélanie Levasseur

Effect of Personalised Citizen Assistance for Social Participation (APIC) on Older Adults' Health and Social Participation: a Pragmatic Multicentre Randomised Controlled Trial (RCT)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Drummondville, Quebec, Canada, J2C 3W1
        • Centre d'action bénévole Drummond
      • Lévis, Quebec, Canada, G6V 1N6
        • Centre d'action bénévole Bellechasse-Lévis-Lotbinière
      • Montréal, Quebec, Canada, H1K 4J4
        • Service d'aide et de référencement Anjou (SARA-Anjou)
      • Montréal, Quebec, Canada, H1X 2X2
        • Carrefour communautaire Montrose
      • Montréal, Quebec, Canada, H4L 3Y6
        • Centre ABC
      • Sherbrooke, Quebec, Canada, J1H 5N6
        • Accorderie de Sherbrooke, coopérative de solidarité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Moderate to severe cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalised citizen assistance
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)
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.
No Intervention: Control group
The control group will receive the publicly-funded universal healthcare services available to all Quebecers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
v2 of the 36-Item Short-Form Health Survey (SF-36) (''change'' is is being assessed)
Time Frame: Baseline, 12, 18, 24 months
Physical and mental health
Baseline, 12, 18, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social participation scale
Time Frame: Baseline, 12, 18, 24 months
Social participation
Baseline, 12, 18, 24 months
Life Satisfaction Index-Z
Time Frame: Baseline, 12, 18, 24 months
Life Satisfaction
Baseline, 12, 18, 24 months
Use of healthcare services-Standardized questionnaire
Time Frame: every two months over a 2-year period
Use of healthcare services
every two months over a 2-year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mélanie Levasseur

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Mélanie Levasseur, Université de Sherbrooke; Research centre on aging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2017

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MP-31-2018-2424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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