- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03634163
Compassionate Communities Neighbourhood Program (WECCC-NHB)
August 14, 2018 updated by: Michelle Howard, McMaster University
Compassionate Communities Neighbourhood Program: Cluster Randomized Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Windsor, Ontario, Canada, N8T 1B5
- Hospice of Windsor-Essex
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate
Quality of Life Assessment plus facilitated implementation of neighbourhood exchange and personal care support
|
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
Completion of baseline measures
|
|
Active Comparator: Delayed
Quality of Life Assessment
|
Completion of baseline measures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perception of social disconnectedness
Time Frame: change from baseline at 7 months
|
Social disconnectedness scale; 8-item validated scale (Cornwell and Waite, 2008), higher scores indicate greater social disconnectedness
|
change from baseline at 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perception of personal well-being
Time Frame: change from baseline at 7 months
|
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
|
|
Perceived loneliness scale
Time Frame: change from baseline at 7 months
|
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
|
|
Attainment of personal goals
Time Frame: Change from baseline at 7 months
|
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
|
|
Health related quality of life
Time Frame: change from baseline at 7 months
|
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
|
|
Perceived provisions of social relationships
Time Frame: change from baseline at 7 months
|
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
|
|
Number of emergency department visits
Time Frame: 7 months
|
Number of emergency department visits measured from health administrative data
|
7 months
|
|
Number of hospital admissions
Time Frame: 7 months
|
Number of hospital admissions measured from health administrative data
|
7 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost-effectiveness
Time Frame: 7 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle Howard, PhD, McMaster University
- Principal Investigator: Lisa Dolovich, PharmD, McMaster University
- Principal Investigator: Kathryn Pfaff, PhD, University of Windsor
- Principal Investigator: Merrick Zwarenstein, PhD, Western University
- Principal Investigator: Denise Marshall, McMaster University
- Principal Investigator: Ross Upshur, Sinai Health Systems
- Principal Investigator: Carol Bennett, Ottawa Hospital Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2018
Primary Completion (Anticipated)
March 31, 2020
Study Completion (Anticipated)
March 31, 2021
Study Registration Dates
First Submitted
July 5, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (Actual)
August 16, 2018
Study Record Updates
Last Update Posted (Actual)
August 16, 2018
Last Update Submitted That Met QC Criteria
August 14, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001-WECCC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.