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

Not Applicable

Completed

Conditions: Heart Failure

Registration Number: NCT04737759

Lead Sponsor: Boston College

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.	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.	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 Outcome Measures

Name	Time	Method
Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition.	5 months after baseline	The 16-item Multidimensional Caregiver Strain Index measures physical, social, interpersonal strain and time constraints and demands related to providing care on a 1-5 scale. Potential range of scores is 16-80 with higher scores indicating greater strain.
Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition	5 months after baseline	Pain interference was assessed using the six-item PROMIS pain interference scale with items ranging from 1-5 for a potential range of 6-30. Higher scores indicate more pain interference. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's pain interference) were calculated.
Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition	5 months after baseline	Collaborative symptom management was assessed using the six-item Stanford Chronic Disease Self-Management measure with items reworded to ask how much couples worked together to prevent symptoms (e.g., fatigue, pain, emotional distress) from interfering with what the person with heart failure wanted to do or to reduce the need to see a provider on a 1 (never) to 10 (always) scale. Average summary scores had the potential to range from 1-10 with higher scores indicating greater collaborative management.
Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.	5 months after baseline	Center for Epidemiological Studies Depression CESD 20-item measure. Items are on a 0-3 scale with potential range of 0-60 with higher scores indicating more depressive symptoms.
Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition	5 months after baseline	Total quality of life score assessed by the 12-item Kansas City Cardiomyopathy Questionnaire. Items are converted to a 0-100 scale with higher scores indicating better heart failure related quality of life.
Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition	5 months after baseline	Patient dyspnea scores assessed by the 6-item Heart Failure Somatic Perception Scale. Items ask about how much the person was bothered by dyspnea during the last week on a 0 (not at all) to 5 (extremely bothersome) scale for a potential range of 0-30. Higher scores indicate greater dyspnea. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's dyspnea) were calculated.
Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.	5 months baseline	Fatigue was assessed using the eight-item PROMIS fatigue scale with items on a 1-5 scale for a potential range of 8-40. Higher scored indicate more fatigue. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's fatigue) were calculated.
Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition	5 months after baseline	Confidence was measured using the 6-item Stanford Chronic Disease Self-Management measure to assess confidence to manage six aspects of the illness (e.g., fatigue, emotional distress) on a 1 (no confidence) to 10 (a great deal of confidence) scale. Summary scores were calculated by average the six items for a potential range of 1-10.Higher scores indicate greater confidence.
Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition	5 months after baseline	Communication within the couple was assessed using both scales from the Dyadic Coping measure. Active engagement has five items that ask about how much one's partner engages in open communication and support on a 1-5 scale for a possible range of 5-25. Higher scores indicate one's partner has a higher level of active engagement.
Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition	5 months after baseline	Communication within the couple was assessed using both scales from the Dyadic Coping measure. Protective buffering has six items that ask about how much one's partner engages in hiding concerns and denying worries on a 1-5 scale for a possible range of 6-30. Higher scores indicate one's partner has a higher level of protective buffering.

Trial Locations

Locations (2): Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Boston College
🇺🇸
Chestnut Hill, Massachusetts, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States