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

Boston College

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Taking Care of Us; Other: SUPPORT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04737759

R21AG068715 (U.S. NIH Grant/Contract)

21.074

Details and patient eligibility

About

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

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Taking Care of Us

Experimental group

Description:

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.

Treatment:

Behavioral: Taking Care of Us

SUPPORT

Active Comparator group

Description:

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.

Treatment:

Other: SUPPORT