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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
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
McMaster University

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1022 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.

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 : September 17, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

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.



Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549845


Contacts
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Contact: Francine Marzanek (905) 525-9140 ext 28501 mlefebv@mcmaster.ca
Contact: Magali Girard (514) 890-8000 ext 31834 magali.girard@gmail.com

Locations
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Canada, Quebec
Centre de recherche du CHUM Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: Magali Girard         
Sponsors and Collaborators
McMaster University
Université de Montréal
Investigators
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Principal Investigator: Gina Agarwal McMaster University
Principal Investigator: Janusz Kaczorowski CHUM (Université de Montréal)

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03549845     History of Changes
Other Study ID Numbers: CHAP052018
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan for individual participant data to be shared. Aggregate data will be shared upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:
Healthcare Utilization
Emergency Department
Hospitalization
Low Income
Social Housing
Older Adults
Quality of Life

Additional relevant MeSH terms:
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Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases