An interventional study of Women@Heart Program in Coronary Heart Disease and Women's Health, sponsored by Ottawa Heart Institute Research Corporation. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
Participants in the W@H group will be assembled in small groups of 6-12 participants and attend 12-biweekly sessions over a 24-week intervention period. The sessions will be led by a trained peer leader and will be held in a variety of convenient locations in close geographic proximity to participants' home postal codes. Participants will receive a manual containing copies of learning exercises and educational material. 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).
Behavioral: Women@Heart Program
Participants in the control group will be eligible to participate in the study, but cannot participate because there are no groups within their geographical region. They will be offered the W@H program after their 26-week follow up.
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.
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)
Time frame: Baseline to week 26 follow up
Smoking Status
Measured by self report and carbon monoxide breath test
Time frame: Baseline to week 26 follow up
Fruit/Vegetable consumption
Measured by two questions from the Ontario Health Study that assess typical daily servings of fruits and vegetables.
Time frame: Baseline to week 26 follow up
Menstrual Status
Measured through self reported menstrual status (i.e., pre, peri or post-menopausal)
Time frame: Baseline to week 26 follow up
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).
Time frame: Baseline to week 26 follow up
Physical Activity
Measured through self reported physical activity
Time frame: Baseline to week 26 follow up
Salt Consumption
Assessed using 1 question from the Canadian Community Health Survey (2015) that assess weekly intake of salty foods.
Time frame: Baseline to week 26 follow up
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).
Time frame: Baseline to week 26 follow up
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Ottawa Heart Institute Research Corporation