NCT03549845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,742

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

3.3 years

First QC Date

May 15, 2018

Last Update Submit

March 13, 2023

Conditions

Keywords

Healthcare UtilizationEmergency DepartmentHospitalizationLow IncomeSocial HousingOlder AdultsQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Healthcare Utilization Composite - Change in CVD-related emergency department visits and hospitalizations

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

    Monthly from 1 year pre-intervention to 1 year post-intervention

Secondary Outcomes (6)

  • 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

  • Quality-Adjusted Life Years (QALYs)

    1 year (post-intervention)

  • Cost-effectiveness

    1 year (post-intervention)

  • +1 more secondary outcomes

Other Outcomes (4)

  • Cardiovascular Risk - Change in blood pressure

    Baseline and 1 year

  • Cardiovascular Risk - Change in body mass index

    Baseline and 1 year

  • Cardiovascular Risk - Change in waist circumference

    Baseline and 1 year

  • +1 more other outcomes

Study Arms (2)

CHAP Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Cardiovascular disease prevention and health promotion

CHAP Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche du CHUM

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusEmergencies

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gina Agarwal

    McMaster University

    PRINCIPAL INVESTIGATOR
  • Janusz Kaczorowski

    CHUM (Université de Montréal)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 8, 2018

Study Start

September 17, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

There is currently no plan for individual participant data to be shared. Aggregate data will be shared upon request.

Locations