Peer Support for Women With Heart Disease: Women@Heart
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|ClinicalTrials.gov Identifier: NCT03286010|
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : May 27, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease Women's Health||Behavioral: Women@Heart Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cluster Randomization Trial of Peer Support for Women With Heart Disease: Women@ Heart|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||July 2021|
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
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.
No Intervention: Control
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.
- Psychosocial well-being as measured by a total composite score [ Time Frame: Baseline to week 26 follow up ]The composite score will combine data from seven measures (ESSI, BCI, BAI, BDI2, MCS, HeartQol and PSS)
- Smoking Status [ Time Frame: Baseline to week 26 follow up ]Measured by self report and carbon monoxide breath test
- Fruit/Vegetable consumption [ Time Frame: Baseline to week 26 follow up ]Measured by two questions from the Ontario Health Study that assess typical daily servings of fruits and vegetables.
- Menstrual Status [ Time Frame: Baseline to week 26 follow up ]Measured through self reported menstrual status (i.e., pre, peri or post-menopausal)
- Gender Role Identity [ Time Frame: Baseline to week 26 follow up ]The BEM Sex Role Inventory will be used to assess participants' feelings towards their own gender role identities (masculine, feminine, androgynous and undifferentiated).
- Physical Activity [ Time Frame: Baseline to week 26 follow up ]Measured through self reported physical activity
- Salt Consumption [ Time Frame: Baseline to week 26 follow up ]Assessed using 1 question from the Canadian Community Health Survey (2015) that assess weekly intake of salty foods.
- Medication Adherence [ Time Frame: Baseline to week 26 follow up ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286010
|Contact: Evyanne Wooding||613-696-7000 ext email@example.com|
|Contact: Harleen Hansfirstname.lastname@example.org|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y4M2|
|Contact: Evyanne Wooding 613-696-7000 ext 17596 email@example.com|
|Principal Investigator:||Robert Reid||Ottawa Heart Institute Research Corporation|