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Couples-based Intervention for Cardiovascular Disease
N/A
Recruiting
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants are ≥ 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial will test whether an 8-week program can improve relationships, mental health, and cardiovascular health.
Who is the study for?
This trial is for couples over 18 years old where one partner has cardiovascular disease. They must be cohabiting, able to commit for 6 months, and understand English. Couples already in therapy or with psychiatric illness/cognitive impairment that affects participation are excluded.Check my eligibility
What is being tested?
The Healing Hearts Together (HHT) program aims to improve relationship quality, mental health, life quality, and heart health over an 8-week course compared to usual care. Outcomes will be measured after the program ends and at a 6-month follow-up.See study design
What are the potential side effects?
Since HHT is a psychological intervention rather than a drug treatment, it may not have typical medical side effects but could potentially cause emotional distress or interpersonal issues within the couple.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relationship quality: DAS
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Healing Hearts TogetherExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
91,828 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in couples therapy or plan to start within 6 months.I have been living with my partner for at least a year.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Healing Hearts Together
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited for this medical investigation?
"Confirmed. According to the information posted on clinicaltrials.gov, this medical study is actively recruiting participants since its inception in October 1 2019 and was last updated in January 14 2022. It seeks 608 individuals at a single site."
Answered by AI
Are more participants being accepted for the trial at this time?
"Per clinicaltrials.gov, this trial is actively searching for participants; the advertisement was first put out on October 1st 2019 and most recently updated January 14th 2022."
Answered by AI
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