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Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes

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ClinicalTrials.gov Identifier: NCT03938116
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Heather Tulloch, Ottawa Heart Institute Research Corporation

Study Description
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Brief Summary:
The purpose of this study is to test the efficacy of the 8-week Healing Hearts Together (HHT) program to improve relationship quality, mental health, quality of life (QoL), and cardiovascular health. This is a randomized controlled trial in which couples are randomly assigned to the HHT group or usual care. Changes in the outcomes of interest will be assessed at the end of the intervention (8 weeks) and 6 months later.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Other: Healing Hearts Together Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Healing Hearts Together Other: Healing Hearts Together
Participants in the HHT group will be assembled in groups and attend 8 weekly 2-hr sessions at UOHI led by 2 facilitators with psychology training. Sessions: 1) focus on understanding love, attachment, and their relationship to heart health; 2) provide an opportunity to share experiences related to cardiovascular disease with partners and peers; and 3) assist in identifying and improving communication patterns that may inhibit positive interactions and healthy behaviours. Participants are introduced to concepts through didactic presentations, videos, group and couple discussion and homework exercises. Participants will receive a folder containing copies of in-session and take-home exercises as well as the Hold Me Tight book to review between sessions.
No Intervention: Usual Care


Outcome Measures
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Primary Outcome Measures :
  1. Relationship quality: DAS [ Time Frame: 8 weeks ]
    Relationship quality will be assessed using the DAS. The DAS is a validated 32-item questionnaire that measures couple satisfaction, cohesion, consensus and affectionate expression. Scores ≥108 are indicative of couple satisfaction, while scores ≤107 indicate distress.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. University of Ottawa Heart Institute (UOHI) patients and their partners
  2. Participants in a romantic relationship who are cohabiting (married, common-law or committed relationship for ≥1 year). No restrictions will be placed on sexual orientation.
  3. Participants are ≥ 18 years of age
  4. Participants are able to read and understand English (HHT materials are only available in English; once efficacy has been established, all materials will be translated to French).
  5. Patients and partners are available to participate for the next 6 months (intervention and follow-up).
  6. Patients and partners are able to provide informed consent.

Exclusion Criteria:

  1. Participants who, in the opinion of the study psychologist, manifest psychiatric illness or cognitive impairment that would preclude participation in HHT (i.e. unable to benefit from the intervention; to prevent disruption of other participants).
  2. Participants who are engaging in couples therapy or plan to engage in couples therapy in the next 6 months.
Contacts and Locations
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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): NCT03938116


Contacts
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Contact: Heather Tulloch, PhD 613-696-7000 hetulloch@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Heather Tulloch    613-696-7000 ext 19705      
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
More Information
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Responsible Party: Heather Tulloch, Psychologist, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03938116    
Other Study ID Numbers: 20190101-01H
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heather Tulloch, Ottawa Heart Institute Research Corporation:
couple relationship
heart disease
Additional relevant MeSH terms:
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Cardiovascular Diseases