Coronary Heart DiseaseNCT03286010
Peer Support for Women With Heart Disease: Women@Heart
A study testing Women@Heart Program in people with Coronary Heart Disease and Women's Health, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Women's Health
- What is being tested?
- Women@Heart Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomization Trial of 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).
- Conditions
- Coronary Heart Disease, Women's Health
- Being tested
- Women@Heart Program
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women@Heart ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Behavioral: Women@Heart Program |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to week 26 follow up
Secondary outcomes (7)
Smoking Status
Measured by self report and carbon monoxide breath test
Measured: Baseline to week 26 follow up
Fruit/Vegetable consumption
Measured by two questions from the Ontario Health Study that assess typical daily servings of fruits and vegetables.
Measured: Baseline to week 26 follow up
Menstrual Status
Measured through self reported menstrual status (i.e., pre, peri or post-menopausal)
Measured: Baseline to week 26 follow up
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).
Measured: Baseline to week 26 follow up
Physical Activity
Measured through self reported physical activity
Measured: Baseline to week 26 follow up
Salt Consumption
Assessed using 1 question from the Canadian Community Health Survey (2015) that assess weekly intake of salty foods.
Measured: Baseline to week 26 follow up
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).
Measured: Baseline to week 26 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Jan 2018
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerri Mullen, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286010
- Sponsor's protocol ID
- 20170613-01H
- Status last verified
- Jul 2024
- First submitted
- 12 Sep 2017
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomization Trial of Peer Support for Women With Heart Disease: Women@ Heart
- ClinicalTrials.gov ID
- NCT03286010
- Acronym / sponsor ID
- 20170613-01H
- Conditions
- Coronary Heart Disease, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Women@Heart ProgramParticipants 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). |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women@Heart ProgramThe 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. | Behavioural | Intervention |
Primary outcome
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)
7 secondary outcomes
Smoking Status
Time frame: Baseline to week 26 follow up
Fruit/Vegetable consumption
Time frame: Baseline to week 26 follow up
Menstrual Status
Time frame: Baseline to week 26 follow up
Gender Role Identity
Time frame: Baseline to week 26 follow up
Physical Activity
Time frame: Baseline to week 26 follow up
Salt Consumption
Time frame: Baseline to week 26 follow up
Medication Adherence
Time frame: Baseline to week 26 follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Mullen principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women@Heart Program in people with Coronary Heart Disease and Women's Health, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial well-being as measured by a total composite score (time frame: Baseline to week 26 follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.