Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing

Pragmatic Randomized Controlled Trial of the Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing

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). 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. A randomized controlled trial will be used to evaluate the impact of CHAP on healthcare utilization by older adults living in subsidized housing.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes Mellitus; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Cardiovascular Health Awareness Program

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: Interventional
• Enrollment (Actual): 2742
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0A9
      • Centre de recherche du CHUM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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)

Number of Arms

2

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.	Behavioral: Cardiovascular Health Awareness Program; Cardiovascular disease prevention and health promotion
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.

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	Change in rate of CVD-related emergency department visits and hospitalizations by postal code from administrative databases (Building-level analysis)	Monthly from 1 year pre-intervention to 1 year post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization - Change in all-cause emergency department visits	Change in rate of all-cause emergency department visits by postal code from administrative	Monthly from 1 year pre-intervention to 1 year post-intervention
Healthcare Utilization - Change in all-cause hospitalizations	Change in all-cause hospitalization rates by postal code from administrative data (building-level)	Monthly from 1 year pre-intervention to 1 year post-intervention
Change in quality of life	Measured using EQ-5D-5L	Baseline and 1 year
Quality-Adjusted Life Years (QALYs)	Calculated from EQ-5D-5L at two time points and Canadian value sets	1 year (post-intervention)
Cost-effectiveness	Calculated from program cost data and health outcomes	1 year (post-intervention)
Participant experience of the CHAP intervention	Participant experience of the intervention will be evaluated through qualitative individual interviews and focus groups of residents.	1 year (post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Risk - Change in blood pressure	Change in measured blood pressure (automated, validated device)	Baseline and 1 year
Cardiovascular Risk - Change in body mass index	Change in body mass index calculated from height and weight (self-reported)	Baseline and 1 year
Cardiovascular Risk - Change in waist circumference	Change in waist circumference (measured with measuring tape)	Baseline and 1 year
Cardiovascular Risk - Change in diabetes risk score	Change in diabetes risk score (CANRISK questionnaire)	Baseline and 1 year

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Université de Montréal
• Investigators: Principal Investigator: Gina Agarwal, McMaster University; Principal Investigator: Janusz Kaczorowski, CHUM (Université de Montréal)

Publications and helpful links

General Publications

• Agarwal G, Girard M, Angeles R, Pirrie M, Lussier MT, Marzanek F, Dolovich L, Paterson JM, Thabane L, Kaczorowski J. Design and rationale for a pragmatic cluster randomized trial of the Cardiovascular Health Awareness Program (CHAP) for social housing residents in Ontario and Quebec, Canada. Trials. 2019 Dec 23;20(1):760. doi: 10.1186/s13063-019-3806-5.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Emergency Department; Older Adults; Hospitalization; Healthcare Utilization; Low Income; Social Housing
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CHAP052018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan for individual participant data to be shared. Aggregate data will be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No