Heart Failure Clinical Trial

Taking Care of Us: A Dyadic Intervention for Heart Failure Couples

Summary

This research study is evaluating the efficacy and feasibility of a novel, dyadic intervention for heart failure couples versus an educational counseling intervention.

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Full Description

There is a critical need for theoretically- and empirically-driven dyadic interventions to improve the outcomes of both adults with heart failure and their partners. The proposed study will evaluate a novel, dyadic program, Taking Care of Us, versus an educational counseling condition using a randomized controlled trial on 72 couples living with heart failure. Both programs are offered via Zoom by trained interventionists and last approximately two months.

Specifically, we will 1) determine the efficacy of the Taking Care of Us intervention on dyadic health; 2) determine the efficacy of the Taking Care of Us intervention on dyadic appraisal and dyadic management; and 3) determine the feasibility and acceptability of the Taking Care of Us intervention.

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Eligibility Criteria

Inclusion Criteria: Adults with Heart Failure:

Diagnosis of heart failure for at least three months
Current heart failure symptoms (i.e., NYHA Class II-III; AHA/ACC Stage C)
Age greater than or equal to 18 years
Willing and able to provide informed consent
Reachable by telephone/email
Access to device with camera (e.g., computer, tablet) to participate in Zoom sessions
Have a co-residing spouse/unmarried partner willing to participate

Inclusion Criteria: Spouses/Partners:

Age greater than or equal to 18 years
Co-residing with the adult with heart failure at time of recruitment
Have lived with the adult with heart failure for at least one year
Willing and able to provide informed consent

Exclusion Criteria:

Major and uncorrected hearing impairment
Significant cognitive impairment
Heart transplantation/mechanical circulatory support prior to enrollment
Concomitant terminal illness that would impede participation
Active psychosis or severe substance abuse that would impair the ability to complete the study
Inability to complete the requirements of the study, including enrolment in an additional trial

Study is for people with:

Heart Failure

Estimated Enrollment:

90

Study ID:

NCT04737759

Recruitment Status:

Completed

Sponsor:

Boston College

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There are 2 Locations for this study

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Tufts Medical Center
Boston Massachusetts, 02111, United States
Boston College
Chestnut Hill Massachusetts, 02467, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

90

Study ID:

NCT04737759

Recruitment Status:

Completed

Sponsor:


Boston College

How clear is this clinincal trial information?

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