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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||376 participants|
|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.|
|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|
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.
- 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
- Social participation scale [ Time Frame: Baseline, 12, 18, 24 months ]Social participation
- Life Satisfaction Index-Z [ Time Frame: Baseline, 12, 18, 24 months ]Life Satisfaction
- Use of healthcare services-Standardized questionnaire [ Time Frame: every two months over a 2-year period ]Use of healthcare services
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
|Contact: Joanie Lacasse-Bédard||1 888 email@example.com|
|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|
|Saint-Laurent, Quebec, Canada, H4L 3Y6|
|Principal Investigator:||Mélanie Levasseur||Université de Sherbrooke; Research centre on aging|