NCT03634163

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

July 5, 2018

Last Update Submit

August 14, 2018

Conditions

Chronic DiseaseAging

Keywords

disability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Perception of personal well-being

    change from baseline at 7 months

  • Perceived loneliness scale

    change from baseline at 7 months

  • Attainment of personal goals

    Change from baseline at 7 months

  • Health related quality of life

    change from baseline at 7 months

  • Perceived provisions of social relationships

    change from baseline at 7 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Cost-effectiveness

    7 months

Study Arms (2)

Immediate

EXPERIMENTAL

Quality of Life Assessment plus facilitated implementation of neighbourhood exchange and personal care support

Behavioral: Neighbourhood exchangeBehavioral: Quality of Life Assessment

Delayed

ACTIVE COMPARATOR

Quality of Life Assessment

Behavioral: Quality of Life Assessment

Interventions

Neighbourhood exchangeBEHAVIORAL

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

Immediate
Quality of Life AssessmentBEHAVIORAL

Completion of baseline measures

DelayedImmediate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospice of Windsor-Essex

Windsor, Ontario, N8T 1B5, Canada

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Howard, PhD

CONTACT

905-525-9140mhoward@mcmaster.ca

Deborah Sattler

CONTACT

416-879-2371deborah@deborahsattler.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster randomization with stepped wedge
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 5, 2018

First Posted

August 16, 2018

Study Start

September 1, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2021

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

CA(1)