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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03161860
Other study ID # MP-31-2018-2424
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 4, 2017
Est. completion date December 2024

Study information

Verified date May 2023
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Centre d'action bénévole Drummond Drummondville Quebec
Canada Centre d'action bénévole Bellechasse-Lévis-Lotbinière Lévis Quebec
Canada Carrefour communautaire Montrose Montréal Quebec
Canada Centre ABC Montréal Quebec
Canada Service d'aide et de référencement Anjou (SARA-Anjou) Montréal Quebec
Canada Accorderie de Sherbrooke, coopérative de solidarité Sherbrooke Quebec

Sponsors (2)

Lead Sponsor Collaborator
Mélanie Levasseur Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Social participation scale Social participation Baseline, 12, 18, 24 months
Secondary Life Satisfaction Index-Z Life Satisfaction Baseline, 12, 18, 24 months
Secondary Use of healthcare services-Standardized questionnaire Use of healthcare services every two months over a 2-year period
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