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Completed

NCT Number: NCT03286010

Peer Support for Women With Heart Disease: Women@Heart

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).

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases Women's Health

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4M2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • 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

  • 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).

Treatment and study plan

Women@Heart Program

Behavioral

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Smoking Status

    Time frame: Baseline to week 26 follow up

    Measured by self report and carbon monoxide breath test

  2. 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.

  3. Menstrual Status

    Time frame: Baseline to week 26 follow up

    Measured through self reported menstrual status (i.e., pre, peri or post-menopausal)

  4. 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).

  5. Physical Activity

    Time frame: Baseline to week 26 follow up

    Measured through self reported physical activity

  6. 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.

  7. 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).

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2017
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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