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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-09

Study Completion Date

2023-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Taking Care of Us

Taking Care of Us involves seven sessions delivered via Zoom to couples over approximately two months. Sessions last approximately 45-60 minutes and are delivered by a trained interventionist. The program is a communication-based, relationship-focused intervention that is strengths-based and fosters new skills to support couples managing heart failure. The goals of the program are to 1) target the couple with heart failure as a team; 2) increase shared appraisal within the couple; 3) improve communication skills within the couple; 4) improve collaboration within the couple and dyadic management of heart failure; 5) improve confidence within the couple; and 6) improve both individual and dyadic health and well-being.

Group Type EXPERIMENTAL

Taking Care of Us

Intervention Type BEHAVIORAL

A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.

SUPPORT

The SUPPORT program involves three sessions delivered via Zoom to couples over approximately two months. Sessions last approximately 45-60 minutes and are delivered by a trained interventionist. This arm is an educational intervention to support management of heart failure.

Group Type ACTIVE_COMPARATOR

SUPPORT

Intervention Type OTHER

SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.

Interventions

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Taking Care of Us

A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.

Intervention Type BEHAVIORAL

SUPPORT

SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No