Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Cardiovascular Diseases, Cardiovascular Risk Factor, Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Cardiovascular Health Awareness Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic cluster randomized controlled trial with parallel intervention and control groups. Randomization will occur at the building level (clusters) and the intervention is open to all building residents.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHAP Intervention<br>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<br>* Cardiovascular disease prevention and health promotion<br>|
| No Intervention: Control<br>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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthcare Utilization, Emergency Department, Hospitalization, Low Income, Social Housing, Older Adults, Quality of Life