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Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living
Karen S Lyons1, Carol J Whitlatch2, Amanda R Vest3,4
1Boston College William F. Connell School of Nursing, Maloney Hall, 231, 140 Commonwealth Avenue, Chestnut Hill, MA, 02467, USA. karen.lyons@bc.edu.
Insights
This study tests the feasibility of the Taking Care of Us© (TCU©) intervention for couples managing heart failure. The TCU© program aims to improve the health of both patients and partners through collaborative illness management.
Area of Science:
- Cardiology
- Health Services Research
- Psychology
Background:
- Heart failure affects over 1 million Americans annually, leading to significant healthcare utilization.
- Spouses/partners play a crucial role in heart failure management but are often overlooked in interventions.
- High levels of care strain and poor health are common among partners of heart failure patients.
Purpose of the Study:
- To test the feasibility and acceptability of the Taking Care of Us© (TCU©) couple-based intervention for heart failure management.
- To explore preliminary changes in dyadic health, appraisal, and collaborative management outcomes.
- To inform refinements for a larger randomized controlled trial.
Main Methods:
- A pilot randomized controlled trial involving 60 couples (adult with heart failure and co-residing partner).
- Two arms: TCU© intervention (7 sessions over 2 months via Zoom) and a control condition (SUPPORT©, 3 sessions over 2 months via Zoom).
- Data collection at baseline, post-treatment, and 3-month follow-up using self-report measures, feasibility metrics (enrollment, retention, completion), and satisfaction surveys.
Main Results:
- Feasibility and acceptability of the TCU© intervention will be assessed through enrollment, retention, completion rates, and participant satisfaction.
- Preliminary changes in dyadic health, dyadic appraisal, and collaborative management will be explored.
- The study will identify benefits and drawbacks of the TCU© program.
Conclusions:
- Theoretically driven, evidence-based dyadic interventions are essential for optimizing the health of couples affected by heart failure.
- Results will guide program refinement and the design of a main trial for the TCU© intervention.
- This study addresses a critical gap in focusing on the dyadic nature of heart failure management.
Background:
There are more than 1 million hospital admissions and 3 million emergency visits for heart failure in the USA 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 change in outcomes 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 60 couples (30 per arm). TCU© couples will receive seven sessions over 2 months via Zoom; SUPPORT© couples will receive three sessions over 2 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, retention, completion, and satisfaction metrics. Preliminary exploration of change in outcomes of TCU© on dyadic health, dyadic appraisal, and collaborative management will also be conducted.
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 any needed refinements of the program and decision to move to a main trial.
Trial Registration:
ClinicalTrials.gov (NCT04737759) registered on 27 January 2021.
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