Clinical trial NCT03286010: Peer Support for Women With Heart Disease: Women@Heart
Official title: Cluster Randomization Trial of Peer Support for Women With Heart Disease: Women@ Heart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Women's Health
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Psychosocial well-being as measured by a total composite score
timeFrame: Baseline to week 26 follow up
Secondary outcomes:
measure: Smoking Status
timeFrame: Baseline to week 26 follow up
measure: Fruit/Vegetable consumption
timeFrame: Baseline to week 26 follow up
measure: Menstrual Status
timeFrame: Baseline to week 26 follow up
measure: Gender Role Identity
timeFrame: Baseline to week 26 follow up
measure: Physical Activity
timeFrame: Baseline to week 26 follow up
measure: Salt Consumption
timeFrame: Baseline to week 26 follow up
measure: Medication Adherence
timeFrame: Baseline to week 26 follow up
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Kerri Mullen
role: PRINCIPAL_INVESTIGATOR
References: