N/A N=74 Randomized Supportive Care

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

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT04737759 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition. — 1.28; -0.03; 0.59; -0.63 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Taking Care of Us (Behavioral); SUPPORT (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston College
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.	1.28; -0.03; 0.59; -0.63	—
PRIMARY Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.	0.39; 0.34; 0.50; -0.21	—
SECONDARY Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.	-5.83; -0.74; -0.44; -0.40	—
SECONDARY Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition.	-1.72; 1.32	—
SECONDARY Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition	5.90; -0.82	—
SECONDARY Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition	-2.06; 0.11; -1.83; 0.47	—
SECONDARY Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition	-3.50; 1.68; -1.61; 2.47	—
SECONDARY Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.	-2.33; -0.21; -3.06; -0.42	—
SECONDARY Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition	1.13; 0.40; 1.20; 0.28	—
SECONDARY Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition	0.33; -0.06; 0.51; -0.23	—
SECONDARY Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition	1.11; -0.58; 2.17; 0.74	—
SECONDARY Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition	-1.39; 0.05; 0.00; 0.42	—

Summary

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04737759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.