Peer Support for Women With Heart Disease: Women@Heart

Coronary Heart Disease Clinical Trial

Official title:

Cluster Randomization Trial of Peer Support for Women With Heart Disease: Women@ Heart

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03286010
• Other study ID #: 20170613-01H
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Evyanne Wooding
• Phone: 613-696-7000
• Email: ewooding[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women who have been hospitalized at UOHI in the past year with stable CHD, including:

AMI; stable angina with corroborating evidence of CHD; recent CABG; or percutaneous coronary intervention (to allow examination of mechanisms linking the intervention and psychosocial well-being with health and healthcare outcomes);

2. Women = 18 years of age (the age of consent in Ontario);

3. Women able to read and understand English or French;

4. 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]);

5. 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);

6. 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);

2. 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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Women's Health

Intervention

Behavioral:
• Women@Heart Program
The Women@Heart program is taught by trained peer leaders. Session content is focused on: emotional support (sharing your story, road to recovery, exploration of feelings, coping with changes, emotional management, coping with distress, effective communication, empowerment); informational support (self care behaviours, risk factor education and management, health care system and community resource navigation); and appraisal support (goal setting, action planning, problem solving, relapse prevention). In total there are 12-biweekly sessions offered over a 24-week period.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosocial well-being as measured by a total composite score	The composite score will combine data from seven measures (ESSI, BCI, BAI, BDI2, MCS, HeartQol and PSS)	Baseline to week 26 follow up
Secondary	Smoking Status	Measured by self report and carbon monoxide breath test	Baseline to week 26 follow up
Secondary	Fruit/Vegetable consumption	Measured by two questions from the Ontario Health Study that assess typical daily servings of fruits and vegetables.	Baseline to week 26 follow up
Secondary	Menstrual Status	Measured through self reported menstrual status (i.e., pre, peri or post-menopausal)	Baseline to week 26 follow up
Secondary	Gender Role Identity	The BEM Sex Role Inventory will be used to assess participants' feelings towards their own gender role identities (masculine, feminine, androgynous and undifferentiated).	Baseline to week 26 follow up
Secondary	Physical Activity	Measured through self reported physical activity	Baseline to week 26 follow up
Secondary	Salt Consumption	Assessed using 1 question from the Canadian Community Health Survey (2015) that assess weekly intake of salty foods.	Baseline to week 26 follow up
Secondary	Medication Adherence	Assessed through two questions asking whether or not participants ever forget to take their medication and if they ever stop taking their medication (if so why).	Baseline to week 26 follow up