Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
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|ClinicalTrials.gov Identifier: NCT03549845|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Cardiovascular Risk Factor Diabetes Mellitus||Behavioral: Cardiovascular Health Awareness Program||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||1022 participants|
|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.
|Masking:||None (Open Label)|
|Official Title:||Pragmatic Randomized Controlled Trial of the Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing|
|Actual Study Start Date :||September 17, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
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.
- Healthcare Utilization - Change in CVD-related emergency department visits [ Time Frame: Monthly from 1 year pre-intervention to 1 year post-intervention ]Change in rate of CVD-related emergency department visits by postal code from administrative databases (Building-level analysis)
- Healthcare Utilization - Change in CVD-related hospitalization [ Time Frame: Monthly from 1 year pre-intervention to 1 year post-intervention ]Change in CVD-related hospitalization rates by postal code from administrative data (building-level)
- 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
- 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)
- Change in quality of life [ Time Frame: Baseline and 1 year ]Measured using EQ-5D-5L
- Quality-Adjusted Life Years (QALYs) [ Time Frame: 1 year (post-intervention) ]Calculated from EQ-5D-5L at two time points and Canadian value sets
- Cost-effectiveness [ Time Frame: 1 year (post-intervention) ]Calculated from program cost data and health outcomes
- 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.
- Cardiovascular Risk - Change in blood pressure [ Time Frame: Baseline and 1 year ]Change in measured blood pressure (automated, validated device)
- 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)
- Cardiovascular Risk - Change in waist circumference [ Time Frame: Baseline and 1 year ]Change in waist circumference (measured with measuring tape)
- Cardiovascular Risk - Change in diabetes risk score [ Time Frame: Baseline and 1 year ]Change in diabetes risk score (CANRISK questionnaire)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549845
|Contact: Francine Marzanek||(905) 525-9140 ext email@example.com|
|Contact: Magali Girard||(514) 890-8000 ext firstname.lastname@example.org|
|Centre de recherche du CHUM||Recruiting|
|Montréal, Quebec, Canada, H2X 0A9|
|Contact: Magali Girard|
|Principal Investigator:||Gina Agarwal||McMaster University|
|Principal Investigator:||Janusz Kaczorowski||CHUM (Université de Montréal)|