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NCT Number: NCT03549845

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche du CHUM

Montreal, Quebec, H2X 0A9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiovascular Health Awareness Program

Behavioral

Cardiovascular disease prevention and health promotion

Primary outcomes

  1. 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

    Change in rate of CVD-related emergency department visits and hospitalizations by postal code from administrative databases (Building-level analysis)

Secondary outcomes

  1. Healthcare Utilization - Change in all-cause emergency department visits

    Time frame: 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

  2. Healthcare Utilization - Change in all-cause hospitalizations

    Time frame: 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)

  3. Change in quality of life

    Time frame: Baseline and 1 year

    Measured using EQ-5D-5L

  4. Quality-Adjusted Life Years (QALYs)

    Time frame: 1 year (post-intervention)

    Calculated from EQ-5D-5L at two time points and Canadian value sets

  5. Cost-effectiveness

    Time frame: 1 year (post-intervention)

    Calculated from program cost data and health outcomes

  6. Participant experience of the CHAP intervention

    Time frame: 1 year (post-intervention)

    Participant experience of the intervention will be evaluated through qualitative individual interviews and focus groups of residents.

Other outcomes

  1. Cardiovascular Risk - Change in blood pressure

    Time frame: Baseline and 1 year

    Change in measured blood pressure (automated, validated device)

  2. Cardiovascular Risk - Change in body mass index

    Time frame: Baseline and 1 year

    Change in body mass index calculated from height and weight (self-reported)

  3. Cardiovascular Risk - Change in waist circumference

    Time frame: Baseline and 1 year

    Change in waist circumference (measured with measuring tape)

  4. Cardiovascular Risk - Change in diabetes risk score

    Time frame: Baseline and 1 year

    Change in diabetes risk score (CANRISK questionnaire)

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Université de Montréal

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 8, 2018
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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