Taking Care of Us (TCU) Study Protocol: A Dyadic Intervention for Couples Living with Heart Failure

Background : There are more than 1 million hospital admissions and 3 million emergency visits for heart failure in the U.S. annually. Although spouse/partners make substantial contributions to the management of heart failure and experience poor health and high levels of care strain, they are rarely the focus of heart failure interventions. This protocol describes a pilot randomized controlled trial that tests the feasibility, acceptability, and preliminary efficacy of a seven-session couple-based intervention called Taking Care of Us (TCU). The TCU intervention is grounded in the Theory of Dyadic Illness Management and was developed to promote collaborative illness management and better physical and mental health of adults with heart failure and their partners. Methods : A two-arm randomized controlled trial will be conducted. Eligible adults with heart failure and their co-residing spouse/partner will be recruited from a clinical site in the USA and community/social media outreach and randomized to either the TCU intervention or to a control condition (SUPPORT) that offers education around heart failure management. The target sample is 72 couples (36 per arm). TCU couples will receive seven sessions over two months via Zoom; SUPPORT couples will receive three sessions over two months via Zoom. All participants will complete self-report measures at baseline (T1), post-treatment (T2), and 3 months post-treatment (T3). Acceptability and feasibility of the intervention will be examined using both closed-ended and open-ended questions as well as enrollment and retention metrics. Preliminary efficacy of TCU on dyadic health, dyadic appraisal, and collaborative management will be examined using standardized measures. Discussion : Theoretically-driven, evidence-based dyadic interventions are needed to optimize the health of both members of the couple living with heart failure. Results from this study will provide important information about recruitment and retention and benefits and drawbacks of the TCU program to directly inform a large-scale grant application to test the impact of the TCU program in a fully powered sample. Trial registration : ClinicalTrials.gov (NCT04737759) registered on 27 January 2021.