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Trial record 16 of 245 for:    "ottawa heart institute"

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 : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Robert Reid, Ottawa Heart Institute Research Corporation

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; arterial health; 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Intervention
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: Wait List Control
Participants assigned to the WLC group will be offered the W@H program after a 26-week waiting period



Primary Outcome Measures :
  1. Psychosocial well-being as measured by a total composite score [ Time Frame: Baseline to week 26 follow up (at the end of the Women@Heart intervention) ]
    The composite score will combine data from seven measures (ESSI, BCI, BAI, BDI2, MCS, HeartQol and PSS)


Secondary Outcome Measures :
  1. Smoking Status [ Time Frame: Baseline to week 26 follow up (at the end of the Women@Heart intervention) ]
    Measured by self report and carbon monoxide breath test

  2. Fruit/Vegetable consumption [ Time Frame: Baseline to week 26 follow up (at the end of the Women@Heart intervention) ]
    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 (at the end of the Women@Heart intervention) ]
    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 (at the end of the Women@Heart intervention) ]
    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 (at the end of the Women@Heart intervention) ]
    Measured through self reported physical activity and quantified through accelerometry (7 day wear time)

  6. Salt Consumption [ Time Frame: Baseline to week 26 follow up (at the end of the Women@Heart intervention) ]
    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 (at the end of the Women@Heart intervention) ]
    Measured using the 8-item Morisky Medication Adherence Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Evyanne Wooding 613-696-7000 ext 17596 ewooding@ottawaheart.ca
Contact: Lisa Cotie lcotie@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4M2
Contact: Evyanne Wooding    613-696-7000 ext 17596    ewooding@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Robert Reid Ottawa Heart Institute Research Corporation

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Responsible Party: Dr Robert Reid, Deputy Chief, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03286010     History of Changes
Other Study ID Numbers: 20170613-01H
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases