Compassionate Communities Neighbourhood Program (WECCC-NHB)
Primary Purpose
Chronic Disease, Aging
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neighbourhood exchange
Quality of Life Assessment
Sponsored by
About this trial
This is an interventional other trial for Chronic Disease focused on measuring disability
Eligibility Criteria
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
Sites / Locations
- Hospice of Windsor-Essex
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate
Delayed
Arm Description
Quality of Life Assessment plus facilitated implementation of neighbourhood exchange and personal care support
Quality of Life Assessment
Outcomes
Primary Outcome Measures
Perception of social disconnectedness
Social disconnectedness scale; 8-item validated scale (Cornwell and Waite, 2008), higher scores indicate greater social disconnectedness
Secondary Outcome Measures
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
Perceived loneliness scale
Assessed by Perceived loneliness scale; 9-item validated scale (Cornwell and Waite, 2009). Higher scores indicated greater perceived isolation
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
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
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)
Number of emergency department visits
Number of emergency department visits measured from health administrative data
Number of hospital admissions
Number of hospital admissions measured from health administrative data
Full Information
NCT ID
NCT03634163
First Posted
July 5, 2018
Last Updated
August 14, 2018
Sponsor
McMaster University
Collaborators
Windsor-Essex Compassionate Care Community, University of Windsor, Hospice of Windsor and Essex County, Erie St. Clair Local Health Integration Network (LHIN), Ontario Trillium Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03634163
Brief Title
Compassionate Communities Neighbourhood Program
Acronym
WECCC-NHB
Official Title
Compassionate Communities Neighbourhood Program: Cluster Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Windsor-Essex Compassionate Care Community, University of Windsor, Hospice of Windsor and Essex County, Erie St. Clair Local Health Integration Network (LHIN), Ontario Trillium Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Aging
Keywords
disability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomization with stepped wedge
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate
Arm Type
Experimental
Arm Description
Quality of Life Assessment plus facilitated implementation of neighbourhood exchange and personal care support
Arm Title
Delayed
Arm Type
Active Comparator
Arm Description
Quality of Life Assessment
Intervention Type
Behavioral
Intervention Name(s)
Neighbourhood exchange
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Assessment
Intervention Description
Completion of baseline measures
Primary Outcome Measure Information:
Title
Perception of social disconnectedness
Description
Social disconnectedness scale; 8-item validated scale (Cornwell and Waite, 2008), higher scores indicate greater social disconnectedness
Time Frame
change from baseline at 7 months
Secondary Outcome Measure Information:
Title
Perception of personal well-being
Description
Assessed by Personal Well-Being Index (PWI); 8-item scale (Personal well-being index 5th edition, 2013). Higher scores indicate greater well-being
Time Frame
change from baseline at 7 months
Title
Perceived loneliness scale
Description
Assessed by Perceived loneliness scale; 9-item validated scale (Cornwell and Waite, 2009). Higher scores indicated greater perceived isolation
Time Frame
change from baseline at 7 months
Title
Attainment of personal goals
Description
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
Time Frame
Change from baseline at 7 months
Title
Health related quality of life
Description
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
Time Frame
change from baseline at 7 months
Title
Perceived provisions of social relationships
Description
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)
Time Frame
change from baseline at 7 months
Title
Number of emergency department visits
Description
Number of emergency department visits measured from health administrative data
Time Frame
7 months
Title
Number of hospital admissions
Description
Number of hospital admissions measured from health administrative data
Time Frame
7 months
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness
Description
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
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Howard, PhD
Phone
905-525-9140
Ext
28502
Email
mhoward@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Sattler
Phone
416-879-2371
Email
deborah@deborahsattler.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Howard, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Dolovich, PharmD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathryn Pfaff, PhD
Organizational Affiliation
University of Windsor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Merrick Zwarenstein, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise Marshall
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ross Upshur
Organizational Affiliation
Sinai Health Systems
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol Bennett
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospice of Windsor-Essex
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8T 1B5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Mulcaster
Phone
519-974-7100
Email
DMulcaster@thehospice.ca
First Name & Middle Initial & Last Name & Degree
Diane Halbgewachs
Phone
519-974-7100
Email
dhalbgewachs@thehospice.ca
First Name & Middle Initial & Last Name & Degree
Deborah Sattler
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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