Taking Care of Us: A Dyadic Intervention for Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Boston College
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This research study is evaluating the efficacy and feasibility of a novel, dyadic intervention for heart failure couples versus an educational counseling intervention.
Detailed 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.
Investigators
Karen Lyons
Associate Professor
Boston College
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
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
Outcomes
Primary Outcomes
Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
Time Frame: 5 months after baseline
Mental quality of life score from the 10-item PROMIS Global Health Short Form. 4 items recoded to 1-5 scale for potential range of 1-20. Higher scores indicate better mental quality of life.
Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
Time Frame: 5 months after baseline
Physical quality of life score from the 10-item PROMIS Global Health Short Form. 4 items recoded to 1-5 scale for potential range of 1-20. Higher scores indicate better physical quality of life.
Secondary Outcomes
- Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition.(5 months after baseline)
- Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.(5 months after baseline)
- Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.(5 months baseline)
- Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition(5 months after baseline)