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Peer Support for Women With Heart Disease: Women@Heart

Primary Purpose

Coronary Heart Disease, Women's Health

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Women@Heart Program

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

University of Ottawa Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Smoking Status

Measured by self report and carbon monoxide breath test

Fruit/Vegetable consumption

Measured by two questions from the Ontario Health Study that assess typical daily servings of fruits and vegetables.

Menstrual Status

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

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).

Physical Activity

Measured through self reported physical activity

Salt Consumption

Assessed using 1 question from the Canadian Community Health Survey (2015) that assess weekly intake of salty foods.

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).

Full Information

NCT ID

NCT03286010

First Posted

September 12, 2017

Last Updated

August 8, 2023

Sponsor

Ottawa Heart Institute Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03286010

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease, Women's Health

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Women@Heart Program

Intervention Description

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 Outcome Measure Information:

Title

Psychosocial well-being as measured by a total composite score

Description

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

Secondary Outcome Measure Information:

Title

Smoking Status

Description

Measured by self report and carbon monoxide breath test

Time Frame

Baseline to week 26 follow up

Title

Fruit/Vegetable consumption

Description

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

Title

Menstrual Status

Description

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

Time Frame

Baseline to week 26 follow up

Title

Gender Role Identity

Description

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

Title

Physical Activity

Description

Measured through self reported physical activity

Time Frame

Baseline to week 26 follow up

Title

Salt Consumption

Description

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

Title

Medication Adherence

Description

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

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evyanne Wooding

Phone

613-696-7000

Ext

17596

ewooding@ottawaheart.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerri Mullen

Organizational Affiliation

Ottawa Heart Institute Research Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y4M2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evyanne Wooding

Phone

613-696-7000

Ext

17596

ewooding@ottawaheart.ca

First Name & Middle Initial & Last Name & Degree

Nia Patel, MSc

Phone

613-696-7000

Ext

17595

niapatel@ottawaheart.ca

First Name & Middle Initial & Last Name & Degree

Kerri-Anne Mullen, PhD

12. IPD Sharing Statement

Plan to Share IPD

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