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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Taking Care of Us: A Dyadic Intervention for Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Taking Care of Us
* Other: SUPPORT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taking Care of Us<br>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<br>* A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.<br>|
| Active Comparator: SUPPORT<br>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<br>* SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | PROMIS Global Health Short Form measures physical, mental and overall quality of life. Higher scores indicate better quality of life | 5 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Center for Epidemiological Studies Depression CESD measure. Lower scores indicate fewer depressive symptoms. | 5 months after baseline | 
| 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. | Stanford PERC Healthcare Utilization measure collects physician, mental health, emergency room visits and hospitalizations. Lower scores indicate less healthcare utilization. | 5 months after baseline | 
| Change in care strain scores in spouses in the TCU vs SUPPORT condition as assessed by the 16-item Multidimensional Caregiver Strain Index. | Multidimensional Caregiver Strain Index measures physical, social, interpersonal strain and time constraints and demands related to providing care. Lower scores indicate less strain. | 5 months after baseline | 
| 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. | Kansas City Cardiomyopathy Questionnaire. Higher scores indicate better heart failure related quality of life. | 5 months after baseline | 
| 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. | 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. | 5 months after baseline | 
| 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. | 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. | 5 months after baseline | 
| Change in difference in fatigue scores in couples in the TCU vs SUPPORT condition as assessed by the 8-item PROMIS Fatigue measure. | 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. | 5 months baseline | 
| Change in collaboration scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Collaboration in Chronic Illness measure. | Collaboration in Chronic Illness measure. Higher scores indicate greater collaboration within couples. | 5 months after baseline | 
| 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. | Stanford Confidence to Manage Chronic Illness measure. Higher scores indicate greater confidence. | 5 months after baseline | 
| Change in communication scores in couples in the TCU vs SUPPORT condition as assessed by the 11-item Dyadic Coping Scale. | Dyadic Coping Scale. Higher scores indicate greater communication (both active communication and less protective buffering) | 5 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Couples, Spouses, Dyads