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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03634163
Other study ID # 001-WECCC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date March 31, 2021

Study information

Verified date August 2018
Source McMaster University
Contact Michelle Howard, PhD
Phone 905-525-9140
Email mhoward@mcmaster.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate a Compassionate Communities-based intervention aimed at reducing social isolation by mobilizing individuals to act on their health and social needs individually, and in collaboration with fellow members of their community. The intervention program includes facilitated building of neighbourhood networks (member benefits include access to practical help, the opportunity to develop meaningful relationships, and community mobilization), and coaching support to work on individualized goal setting and more detailed navigation support and planning.


Description:

The Compassionate Communities intervention is catalyzed by professional facilitators who visit communities with high concentrations of elderly and vulnerable residents, and recruit those who are interested in a project to identify their own health and social needs, assets and priorities; to collectively work to support each other in achieving these; and to implement a neighbourhood exchange to more easily match offers of help to people who need help. The mobilization work starts with the facilitator, who is employed by a community or social service organization, but increasingly draws on the energies of the mobilized initial participants as volunteers who conduct further community outreach in their community, attracting and mobilizing other residents, peers, and neighbouring resources in the work. Participants also plan and implement a broad range of activities identified by the residents as their priorities for neighbourhood building. Participants and their caregivers have the option of receiving more in-depth 1:1 coaching support to work on individualized goal setting, more detailed navigation support or advanced care planning following the sessions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date March 31, 2021
Est. primary completion date March 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Seniors (65 years of age and older)

- people with disabilities

- caregivers of seniors or people with disabilities

- residing in identified buildings/ neighbourhoods where the WECCC Compassionate Communities Neighbourhood program is being launched

- able to communicate in English or interpreter can be arranged

Exclusion Criteria:

- not able to communicate in English and interpreter cannot be arranged

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Neighbourhood exchange
Facilitated coaching support to identify needs and priorities and link with resources - personal, community, friend and family, or from professional service providers; plan and implement a personalized care pathway through community exchange
Quality of Life Assessment
Completion of baseline measures

Locations

Country Name City State
Canada Hospice of Windsor-Essex Windsor Ontario

Sponsors (6)

Lead Sponsor Collaborator
McMaster University Erie-St. Clair Local Health Integration Network, Hospice of Windsor and Essex County, Ontario Trillium Foundation, University of Windsor, Windsor-Essex Compassionate Care Community

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Cost-effectiveness Cost-effectiveness ratio measured as difference between groups in total health care utilization costs (measured from administrative data) divided by quality adjusted life years gained from the intervention 7 months
Primary Perception of social disconnectedness Social disconnectedness scale; 8-item validated scale (Cornwell and Waite, 2008), higher scores indicate greater social disconnectedness change from baseline at 7 months
Secondary Perception of personal well-being Assessed by Personal Well-Being Index (PWI); 8-item scale (Personal well-being index 5th edition, 2013). Higher scores indicate greater well-being change from baseline at 7 months
Secondary Perceived loneliness scale Assessed by Perceived loneliness scale; 9-item validated scale (Cornwell and Waite, 2009). Higher scores indicated greater perceived isolation change from baseline at 7 months
Secondary Attainment of personal goals Assessed by Goal Attainment Scaling (GAS) instrument, measured on 5-point scale for each goal identified (Hurn et al, 2006), higher score indicates greater goal attainment Change from baseline at 7 months
Secondary Health related quality of life Assessed by Euroqol 5 dimension 5 level (5D-5L) scale; 5 levels of response for each of 5 items, score is converted to a single index, standardized to scale of 0 to 1, 1 being perfect health change from baseline at 7 months
Secondary Perceived provisions of social relationships Social provisions scale; 10-item validated scale consisting of 5 subscales (Caron, 2013). The SPS 10 measures the perception of social support and consists of 10 items expressed as statements with responses coded on a 4-point scale from strongly disagree (= 1) to strongly agree (= 4). The total SPS-10 score is formed by the summation of raw scores, with high score indicating a higher degree of social provisions (maximum score of 40) change from baseline at 7 months
Secondary Number of emergency department visits Number of emergency department visits measured from health administrative data 7 months
Secondary Number of hospital admissions Number of hospital admissions measured from health administrative data 7 months
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