Clinical trial NCT03161860: Effect of Personalised Citizen Assistance for Social Participation(APIC) on Older Adults Health and Social Participation
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Community-dwelling Older Adults
Keywords: Program evaluation
Cost-effectiveness
Community participation
empowerment
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-05-22
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: v2 of the 36-Item Short-Form Health Survey (SF-36) (''change'' is is being assessed)
timeFrame: Baseline, 12, 18, 24 months
Secondary outcomes:
measure: Social participation scale
timeFrame: Baseline, 12, 18, 24 months
measure: Life Satisfaction Index-Z
timeFrame: Baseline, 12, 18, 24 months
measure: Use of healthcare services-Standardized questionnaire
timeFrame: every two months over a 2-year period
Other outcomes:
Locations:
city: Drummondville
country: Canada
facility: Centre d'action bénévole Drummond
state: Quebec
city: Lévis
country: Canada
facility: Centre d'action bénévole Bellechasse-Lévis-Lotbinière
state: Quebec
city: Montréal
country: Canada
facility: Service d'aide et de référencement Anjou (SARA-Anjou)
state: Quebec
city: Montréal
country: Canada
facility: Carrefour communautaire Montrose
state: Quebec
city: Montréal
country: Canada
facility: Centre ABC
state: Quebec
city: Sherbrooke
country: Canada
facility: Accorderie de Sherbrooke, coopérative de solidarité
state: Quebec
Study officials:
affiliation: Université de Sherbrooke; Research centre on aging
name: Mélanie Levasseur
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.