Clinical trial NCT04737759: Taking Care of Us: A Dyadic Intervention for Heart Failure Couples
Official title: Taking Care of Us: A Dyadic Intervention for Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Couples
Spouses
Dyads
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-02-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
timeFrame: 5 months after baseline
measure: Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
timeFrame: 5 months after baseline
Secondary outcomes:
measure: Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.
timeFrame: 5 months after baseline
measure: Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition.
timeFrame: 5 months after baseline
measure: Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition
timeFrame: 5 months after baseline
measure: Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition
timeFrame: 5 months after baseline
measure: Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition
timeFrame: 5 months after baseline
measure: Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.
timeFrame: 5 months baseline
measure: Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition
timeFrame: 5 months after baseline
measure: Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition
timeFrame: 5 months after baseline
measure: Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition
timeFrame: 5 months after baseline
measure: Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition
timeFrame: 5 months after baseline
Other outcomes:
measure: Satisfaction Scores in Couples in the TCU Condition as a Measure of Acceptability.
timeFrame: 5 months after baseline
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Boston College
state: Massachusetts
Study officials:
affiliation: Boston College
name: Karen S Lyons, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston College
name: Christopher S Lee, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: