NCT03286010Completed
Peer Support for Women With Heart Disease: Women@Heart
Cluster Randomization Trial of Peer Support for Women With Heart Disease: Women@ Heart
Source: ClinicalTrials.gov · Last updated 16 Jul 2024
Brief summary (registry, in English)
Women with heart disease are more likely to die or suffer another cardiac event or stroke within 5 years of an index event compared to men. They are also more likely to suffer depression and report lower quality of life. Cardiac Rehabilitation programs have been designed to address these issues, but most women do not attend. Women indicate they have a greater need to talk about their experiences with heart disease and seek social support to help them cope. Peer support, the assistance provided by other women with a similar illness experience, may be one way to enhance social support for women with heart disease and help them improve their psychosocial well-being. The Investigators have developed a peer support program called Women@Heart (W@H). The program is led by trained peer leaders (women who themselves have made a successful recovery from a heart event). A pilot test of the program showed promising results. The Investigators now need to conduct a more rigorous evaluation of the program. The main objective of this project is to determine if the W@H program helps women to improve their psychosocial well-being compared to being on a waiting list to participate in the program. It will also examine the effect of the program on: health behaviours (tobacco smoking, physical activity, sedentary behaviour, fruit and vegetable consumption, and medication adherence); coronary risk factors; and clinical outcomes (re-hospitalization, health care system use, death).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 12 Sept 2017
- Start date
- 1 Jan 2018
- Primary completion date
- 17 Jun 2024
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Diseases
- Coronary artery disease
- NCT number
- NCT03286010
What you commit to
- Study type: Interventional
- Participants enrolled: 180
- From 1 Jan 2018 to the primary completion date, 17 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Women ≥ 18 years of age (the age of consent in Ontario);
- Women able to read and understand English or French;
- Women who reside in Ontario and are eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences \[ICES\]);
- Women available to participate over the next 6 months (the intervention and data collection takes place over this time frame -- reducing the probability of missing data);
- Women able to provide informed consent. Exclusion Criteria: 1. Women who have been hospitalized primarily for valve replacement or repair, HF, pulmonary hypertension, endocarditis or pericarditis (to reduce heterogeneity and avoid confounding when examining mechanisms linking the intervention and psychosocial well-being with health and healthcare outcomes);
- Women who, in the opinion of the UOHI clinical psychologist, manifest psychiatric illness or cognitive impairment that would preclude participation in W@H (i.e. they are unable to benefit from the intervention, to prevent disruption of other participants).
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.