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

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ClinicalTrials.gov Identifier: NCT03161860
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Mélanie Levasseur, Université de Sherbrooke

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.


Condition or disease Intervention/treatment Phase
Community-dwelling Older Adults Behavioral: Personalised citizen assistance for social participation(APIC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Effect of Personalised Citizen Assistance for Social Participation (APIC) on Older Adults' Health and Social Participation: a Pragmatic Multicentre Randomised Controlled Trial (RCT)
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Social participation scale [ Time Frame: Baseline, 12, 18, 24 months ]
    Social participation

  2. Life Satisfaction Index-Z [ Time Frame: Baseline, 12, 18, 24 months ]
    Life Satisfaction

  3. Use of healthcare services-Standardized questionnaire [ Time Frame: every two months over a 2-year period ]
    Use of healthcare services



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161860


Contacts
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Contact: Joanie Lacasse-Bédard 1 888 780-8990 joanie.lacasse-bedard@usherbrooke.ca

Locations
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Canada, Quebec
Centre d'action bénévole Bellechasse-Lévis-Lotbinière Recruiting
Lévis, Quebec, Canada, G6V 1N6
Service d'aide et de référencement Anjou (SARA-Anjou) Suspended
Montréal, Quebec, Canada, H1K 4J4
Carrefour communautaire Montrose Recruiting
Montréal, Quebec, Canada, H1X 2X2
Centre ABC Recruiting
Saint-Laurent, Quebec, Canada, H4L 3Y6
Sponsors and Collaborators
Mélanie Levasseur
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Mélanie Levasseur Université de Sherbrooke; Research centre on aging

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mélanie Levasseur, Research Professor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03161860     History of Changes
Other Study ID Numbers: MP-31-2018-2424
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mélanie Levasseur, Université de Sherbrooke:
Program evaluation
Cost-effectiveness
Community participation
empowerment