- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03549845
Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
Pragmatic Randomized Controlled Trial of the Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
Study Overview
Status
Intervention / Treatment
Detailed Description
This project aims to improve the cardiovascular health of seniors living in subsidized housing by implementing the successful community-based Cardiovascular Health Awareness Program (CHAP). Residents in subsidized housing are considered to be a vulnerable population because of their low income and tend to be in poorer health; with a multitude of chronic illnesses, such as cardiovascular disease (CVD) and diabetes.
This project will build on the success of CHAP in other provinces. The program has been shown to reduce blood pressure and CVD-related hospitalization costs. CHAP is a patient-centred, interdisciplinary, multi-pronged, community-led CVD and stroke prevention and management program designed to prevent and reduce the impact of cardiovascular disease in older adults. The program addresses common cardiovascular disease risk factors, such as smoking, physical activity and poor diet by raising awareness of health and community resources available to encourage self-care and appropriate management of cardiovascular disease.
Taking the form of a randomized controlled trial, the sample will be subsidized housing buildings (low income) for those aged 55 years and over. During CHAP monthly assessment sessions, participants will 1) complete a consent form, 2) complete a cardiovascular risk profile form, 3) undergo blood pressure measurement using an automated blood pressure measuring device, 4) receive targeted healthy lifestyle and preventive care materials, 5) be invited to participate in group health education sessions. Those patients identified at high risk will be assessed by a health professional and referred to a family physician for timely and appropriate follow-up.. The impact this program will have on health care utilization (emergency visits, cardiovascular hospitalization rates) will be measured using administrative databases.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montréal, Quebec, Canada, H2X 0A9
- Centre de Recherche du CHUM
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Building Inclusion Criteria:
- Approximately 50-200 apartment units
- Majority of residents are 55 years of age or older.
- Unique postal code
- Availability of at least one building with similar characteristics for matching/randomization
Individual Inclusion Criteria
- Resides in a study building
- Aged 55 years or older
- Speaks and reads English or French
Note: Younger residents will be allowed to take part in the program but their data will not be included in the analysis.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHAP Intervention
The Cardiovascular Health Awareness Program (CHAP) intervention is an on-site drop-in, monthly, cardiovascular risk assessment program run by trained volunteers with community-led group health sessions that deliver education and information about access to community health resources.
The education sessions will be delivered by national and provincial and local community organizations utilizing already developed material as much as possible, but maintaining consistency across both provinces.
Health education sessions will include topics such as: Physical Activity, Healthy Eating, Stress, Tobacco Use, High Blood Pressure, Role of Pharmacist: How they can assist people, and Appropriate use of 9-1-1.
This intervention will be held in a common room in selected subsidized housing buildings.
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Cardiovascular disease prevention and health promotion
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No Intervention: Control
The control buildings will receive usual care which will be wellness programs already present in the building prior to the RCT if these are present.
Not all control buildings will have wellness programs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare Utilization Composite - Change in CVD-related emergency department visits and hospitalizations
Time Frame: Monthly from 1 year pre-intervention to 1 year post-intervention
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Change in rate of CVD-related emergency department visits and hospitalizations by postal code from administrative databases (Building-level analysis)
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Monthly from 1 year pre-intervention to 1 year post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare Utilization - Change in all-cause emergency department visits
Time Frame: Monthly from 1 year pre-intervention to 1 year post-intervention
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Change in rate of all-cause emergency department visits by postal code from administrative
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Monthly from 1 year pre-intervention to 1 year post-intervention
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Healthcare Utilization - Change in all-cause hospitalizations
Time Frame: Monthly from 1 year pre-intervention to 1 year post-intervention
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Change in all-cause hospitalization rates by postal code from administrative data (building-level)
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Monthly from 1 year pre-intervention to 1 year post-intervention
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Change in quality of life
Time Frame: Baseline and 1 year
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Measured using EQ-5D-5L
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Baseline and 1 year
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Quality-Adjusted Life Years (QALYs)
Time Frame: 1 year (post-intervention)
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Calculated from EQ-5D-5L at two time points and Canadian value sets
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1 year (post-intervention)
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Cost-effectiveness
Time Frame: 1 year (post-intervention)
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Calculated from program cost data and health outcomes
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1 year (post-intervention)
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Participant experience of the CHAP intervention
Time Frame: 1 year (post-intervention)
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Participant experience of the intervention will be evaluated through qualitative individual interviews and focus groups of residents.
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1 year (post-intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular Risk - Change in blood pressure
Time Frame: Baseline and 1 year
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Change in measured blood pressure (automated, validated device)
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Baseline and 1 year
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Cardiovascular Risk - Change in body mass index
Time Frame: Baseline and 1 year
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Change in body mass index calculated from height and weight (self-reported)
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Baseline and 1 year
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Cardiovascular Risk - Change in waist circumference
Time Frame: Baseline and 1 year
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Change in waist circumference (measured with measuring tape)
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Baseline and 1 year
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Cardiovascular Risk - Change in diabetes risk score
Time Frame: Baseline and 1 year
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Change in diabetes risk score (CANRISK questionnaire)
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Baseline and 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gina Agarwal, McMaster University
- Principal Investigator: Janusz Kaczorowski, CHUM (Université de Montréal)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHAP052018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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