Cardiovascular DiseasesNCT03549845
Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
A study testing Cardiovascular Health Awareness Program in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by McMaster University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, Diabetes Mellitus
- What is being tested?
- Cardiovascular Health Awareness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,742 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Randomized Controlled Trial of the Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
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.
Read the 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.
- Being tested
- Cardiovascular Health Awareness Program
- Keywords
- Healthcare Utilization, Emergency Department, Hospitalization, Low Income, Social Housing, Older Adults, Quality of Life
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Health Awareness ProgramBehavioural
Cardiovascular disease prevention and health promotion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Monthly from 1 year pre-intervention to 1 year post-intervention
Secondary outcomes (6)
Healthcare Utilization - Change in all-cause emergency department visits
Change in rate of all-cause emergency department visits by postal code from administrative
Measured: Monthly from 1 year pre-intervention to 1 year post-intervention
Healthcare Utilization - Change in all-cause hospitalizations
Change in all-cause hospitalization rates by postal code from administrative data (building-level)
Measured: Monthly from 1 year pre-intervention to 1 year post-intervention
Change in quality of life
Measured using EQ-5D-5L
Measured: Baseline and 1 year
Quality-Adjusted Life Years (QALYs)
Calculated from EQ-5D-5L at two time points and Canadian value sets
Measured: 1 year (post-intervention)
Cost-effectiveness
Calculated from program cost data and health outcomes
Measured: 1 year (post-intervention)
Participant experience of the CHAP intervention
Participant experience of the intervention will be evaluated through qualitative individual interviews and focus groups of residents.
Measured: 1 year (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start17 Sep 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2,742 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Gina Agarwal, Principal investigator, McMaster UniversityJanusz Kaczorowski, Principal investigator, CHUM (Université de Montréal)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549845
- Sponsor's protocol ID
- CHAP052018
- Status last verified
- Mar 2023
- First submitted
- 15 May 2018
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan for individual participant data to be shared. Aggregate data will be shared upon request.
Publications
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.
PubMed 31870415
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of the Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
- ClinicalTrials.gov ID
- NCT03549845
- Acronym / sponsor ID
- CHAP052018
- Keywords
- Healthcare Utilization, Emergency Department, Hospitalization, Low Income, Social Housing, Older Adults, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,742 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CHAP Intervention | Experimental | Behavioral: Cardiovascular Health Awareness ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Health Awareness ProgramCardiovascular disease prevention and health promotion | Behavioural | CHAP Intervention |
Primary outcome
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)
6 secondary outcomes
Healthcare Utilization - Change in all-cause emergency department visits
Time frame: Monthly from 1 year pre-intervention to 1 year post-intervention
Healthcare Utilization - Change in all-cause hospitalizations
Time frame: Monthly from 1 year pre-intervention to 1 year post-intervention
Change in quality of life
Time frame: Baseline and 1 year
Quality-Adjusted Life Years (QALYs)
Time frame: 1 year (post-intervention)
Cost-effectiveness
Time frame: 1 year (post-intervention)
Participant experience of the CHAP intervention
Time frame: 1 year (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 31870415Agarwal 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.
- Individual participant dataSharing planned: No. There is currently no plan for individual participant data to be shared. Aggregate data will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Agarwal principal investigator
McMaster University
Janusz Kaczorowski principal investigator
CHUM (Université de Montréal)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular Health Awareness Program in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.