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Clinical Trials/NCT03549845
NCT03549845
Completed
Not Applicable

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

McMaster University1 site in 1 country2,742 target enrollmentSeptember 17, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
McMaster University
Enrollment
2742
Locations
1
Primary Endpoint
Healthcare Utilization Composite - Change in CVD-related emergency department visits and hospitalizations
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 17, 2018
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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

  • Quality-Adjusted Life Years (QALYs)(1 year (post-intervention))
  • Cost-effectiveness(1 year (post-intervention))
  • Participant experience of the CHAP intervention(1 year (post-intervention))
  • Healthcare Utilization - Change in all-cause emergency department visits(Monthly from 1 year pre-intervention to 1 year post-intervention)
  • Healthcare Utilization - Change in all-cause hospitalizations(Monthly from 1 year pre-intervention to 1 year post-intervention)
  • Change in quality of life(Baseline and 1 year)

Study Sites (1)

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