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

• ClinicalTrials.gov Identifier: NCT04737759
• Recruitment Status: Active, not recruiting
• First Posted: February 4, 2021
• Last Update Posted: February 8, 2023
• Sponsor: Boston College
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Karen Lyons, Boston College

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Behavioral: Taking Care of Us; Other: SUPPORT	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Taking Care of Us: A Dyadic Intervention for Heart Failure
• Actual Study Start Date: July 9, 2021
• Estimated Primary Completion Date: May 31, 2023
• Estimated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Taking Care of Us; 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.	Behavioral: Taking Care of Us; A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
Active Comparator: SUPPORT; 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.	Other: SUPPORT; SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.

Outcome Measures

Primary Outcome Measures :

1. Change in quality of life scores in couples in the TCU vs SUPPORT condition assessed by the 10-item PROMIS Global Health Short Form measure [ Time Frame: 5 months after baseline ]
   PROMIS Global Health Short Form measures physical, mental and overall quality of life. Higher scores indicate better quality of life

Secondary Outcome Measures :

1. Change in depressive symptom scores in couples in the TCU vs SUPPORT condition as assessed by the 20-item Center for Epidemiological Studies Depression CESD measure. [ Time Frame: 5 months after baseline ]
   Center for Epidemiological Studies Depression CESD measure. Lower scores indicate fewer depressive symptoms.
2. Change in healthcare utilization scores in couples in the TCU vs SUPPORT condition as assessed by the 5-item Stanford Patient Education Research Center PERC Healthcare Utilization measure. [ Time Frame: 5 months after baseline ]
   Stanford PERC Healthcare Utilization measure collects physician, mental health, emergency room visits and hospitalizations. Lower scores indicate less healthcare utilization.
3. Change in care strain scores in spouses in the TCU vs SUPPORT condition as assessed by the 16-item Multidimensional Caregiver Strain Index. [ Time Frame: 5 months after baseline ]
   Multidimensional Caregiver Strain Index measures physical, social, interpersonal strain and time constraints and demands related to providing care. Lower scores indicate less strain.
4. Change in heart failure related quality of life scores in persons with heart failure in the TCU vs SUPPORT condition as assessed by the 12-item Kansas City Cardiomyopathy Questionnaire. [ Time Frame: 5 months after baseline ]
   Kansas City Cardiomyopathy Questionnaire. Higher scores indicate better heart failure related quality of life.
5. Change in difference in dyspnea scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Heart Failure Somatic Perception Scale. [ Time Frame: 5 months after baseline ]
   Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.
6. Change in difference in pain interference scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item PROMIS Pain Interference measure. [ Time Frame: 5 months after baseline ]
   Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.
7. Change in difference in fatigue scores in couples in the TCU vs SUPPORT condition as assessed by the 8-item PROMIS Fatigue measure. [ Time Frame: 5 months baseline ]
   Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.
8. Change in collaboration scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Collaboration in Chronic Illness measure. [ Time Frame: 5 months after baseline ]
   Collaboration in Chronic Illness measure. Higher scores indicate greater collaboration within couples.
9. Change in confidence scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Stanford Confidence to Manage Chronic Illness measure. [ Time Frame: 5 months after baseline ]
   Stanford Confidence to Manage Chronic Illness measure. Higher scores indicate greater confidence.
10. Change in communication scores in couples in the TCU vs SUPPORT condition as assessed by the 11-item Dyadic Coping Scale. [ Time Frame: 5 months after baseline ]
    Dyadic Coping Scale. Higher scores indicate greater communication (both active communication and less protective buffering)

Other Outcome Measures:

1. Change in satisfaction scores in couples in the TCU vs SUPPORT condition as assessed by the Satisfaction and Advantages/Drawbacks measure. [ Time Frame: 5 months after baseline ]
   Satisfaction and Advantages/Drawbacks measure. Higher scores indicate greater satisfaction with assigned program.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Boston College

Chestnut Hill, Massachusetts, United States, 02467

Sponsors and Collaborators

Boston College

National Institute on Aging (NIA)

More Information

• Responsible Party: Karen Lyons, Associate Professor, Boston College
• ClinicalTrials.gov Identifier: NCT04737759
• Other Study ID Numbers: 21.074; R21AG068715 ( U.S. NIH Grant/Contract )
• First Posted: February 4, 2021
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Lyons, Boston College:

Couples; Spouses; Dyads

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases