Clinical trial NCT03549845: Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
Official title: Pragmatic Randomized Controlled Trial of the Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Diabetes Mellitus
Keywords: Healthcare Utilization
Emergency Department
Hospitalization
Low Income
Social Housing
Older Adults
Quality of Life
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2018-06-08
Enrollment: 2742
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Healthcare Utilization Composite - Change in CVD-related emergency department visits and hospitalizations
timeFrame: Monthly from 1 year pre-intervention to 1 year post-intervention
Secondary outcomes:
measure: Healthcare Utilization - Change in all-cause emergency department visits
timeFrame: Monthly from 1 year pre-intervention to 1 year post-intervention
measure: Healthcare Utilization - Change in all-cause hospitalizations
timeFrame: Monthly from 1 year pre-intervention to 1 year post-intervention
measure: Change in quality of life
timeFrame: Baseline and 1 year
measure: Quality-Adjusted Life Years (QALYs)
timeFrame: 1 year (post-intervention)
measure: Cost-effectiveness
timeFrame: 1 year (post-intervention)
measure: Participant experience of the CHAP intervention
timeFrame: 1 year (post-intervention)
Other outcomes:
measure: Cardiovascular Risk - Change in blood pressure
timeFrame: Baseline and 1 year
measure: Cardiovascular Risk - Change in body mass index
timeFrame: Baseline and 1 year
measure: Cardiovascular Risk - Change in waist circumference
timeFrame: Baseline and 1 year
measure: Cardiovascular Risk - Change in diabetes risk score
timeFrame: Baseline and 1 year
Locations:
city: Montréal
country: Canada
facility: Centre de recherche du CHUM
state: Quebec
Study officials:
affiliation: McMaster University
name: Gina Agarwal
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUM (Université de Montréal)
name: Janusz Kaczorowski
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agarwal G, Girard M, Angeles R, Pirrie M, Lussier MT, Marzanek F, Dolovich L, Paterson JM, Thabane L, Kaczorowski J. Design and rationale for a pragmatic cluster randomized trial of the Cardiovascular Health Awareness Program (CHAP) for social housing residents in Ontario and Quebec, Canada. Trials. 2019 Dec 23;20(1):760. doi: 10.1186/s13063-019-3806-5.