Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549845
• Other study ID #: CHAP052018
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2742
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Diabetes Mellitus

Intervention

Behavioral:
• Cardiovascular Health Awareness Program
Cardiovascular disease prevention and health promotion

Locations

Country	Name	City	State
Canada	Centre de recherche du CHUM	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular Risk - Change in blood pressure	Change in measured blood pressure (automated, validated device)	Baseline and 1 year
Other	Cardiovascular Risk - Change in body mass index	Change in body mass index calculated from height and weight (self-reported)	Baseline and 1 year
Other	Cardiovascular Risk - Change in waist circumference	Change in waist circumference (measured with measuring tape)	Baseline and 1 year
Other	Cardiovascular Risk - Change in diabetes risk score	Change in diabetes risk score (CANRISK questionnaire)	Baseline and 1 year
Primary	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	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
Secondary	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
Secondary	Change in quality of life	Measured using EQ-5D-5L	Baseline and 1 year
Secondary	Quality-Adjusted Life Years (QALYs)	Calculated from EQ-5D-5L at two time points and Canadian value sets	1 year (post-intervention)
Secondary	Cost-effectiveness	Calculated from program cost data and health outcomes	1 year (post-intervention)
Secondary	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)