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

Study Overview
=================
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.

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)

Conditions
-----------------
Community-dwelling Older Adults

Intervention / Treatment
-----------------
* Behavioral: Personalised citizen assistance for social participation(APIC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Moderate to severe cognitive impairments

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalised citizen assistance<br>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)<br>* 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.<br>|
| No Intervention: Control group<br>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) | Physical and mental health | Baseline, 12, 18, 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
empowerment, Program evaluation, Cost-effectiveness, Community participation