Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing

Sponsor

McMaster University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03549845

Collaborator

Université de Montréal (Other)

2,742

Enrollment

Location

Arms

38.5

Anticipated Duration (Months)

71.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Cardiovascular Risk Factor Diabetes Mellitus	Behavioral: Cardiovascular Health Awareness Program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2742 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 17, 2018

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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