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

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.

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

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.

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