Cardiovascular DiseasesNCT03938116
Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes
A study testing Healing Hearts Together in people with Cardiovascular Diseases, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Healing Hearts Together
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 17 Apr 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University of Ottawa Heart Institute (UOHI) patients and their partners
- 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.
- Participants are ≥ 18 years of age
- 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).
- Patients and partners are available to participate for the next 6 months (intervention and follow-up).
- Patients and partners are able to provide informed consent.
Who cannot join
- 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).
- Participants who are engaging in couples therapy or plan to engage in couples therapy in the next 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Healing Hearts Together
- Keywords
- couple relationship, heart disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing Hearts TogetherOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healing Hearts Together | Experimental | Not described Receives: Other: Healing Hearts Together |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship quality: DAS
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Oct 2019
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938116
- Sponsor's protocol ID
- 20190101-01H
- Status last verified
- Nov 2025
- First submitted
- 25 Apr 2019
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes
- ClinicalTrials.gov ID
- NCT03938116
- Acronym / sponsor ID
- 20190101-01H
- Conditions
- Cardiovascular Diseases
- Keywords
- couple relationship, heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 6 May 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healing Hearts Together | Experimental | Other: Healing Hearts Together |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- University of Ottawa Heart Institute (UOHI) patients and their partners
- 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.
- Participants are ≥ 18 years of age
- 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).
- Patients and partners are available to participate for the next 6 months (intervention and follow-up).
Key exclusion criteria (2 listed)
- 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).
- Participants who are engaging in couples therapy or plan to engage in couples therapy in the next 6 months.
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 |
|---|---|---|
| Healing Hearts TogetherParticipants 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. | Other | Healing Hearts Together |
Primary outcome
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.
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 6 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Hearts Together in people with Cardiovascular Diseases, 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 6 May 2026. 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?
Relationship quality: DAS (time frame: 8 weeks). 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 6 May 2026.