Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure
Abstract 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 r...
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| Format: | Article |
| Language: | English |
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BMC
2023-01-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-023-01249-7 |
| _version_ | 1811176017000136704 |
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| author | Karen S. Lyons Carol J. Whitlatch Amanda R. Vest Jenica N. Upshaw Stacy Hutton Johnson Jeremiah Morelock Christopher S. Lee |
| author_facet | Karen S. Lyons Carol J. Whitlatch Amanda R. Vest Jenica N. Upshaw Stacy Hutton Johnson Jeremiah Morelock Christopher S. Lee |
| author_sort | Karen S. Lyons |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-10T19:45:10Z |
| format | Article |
| id | doaj.art-5a1ae3538e374d27a5807c064bd4954f |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-04-10T19:45:10Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-5a1ae3538e374d27a5807c064bd4954f2023-01-29T12:04:39ZengBMCPilot and Feasibility Studies2055-57842023-01-019111110.1186/s40814-023-01249-7Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failureKaren S. Lyons0Carol J. Whitlatch1Amanda R. Vest2Jenica N. Upshaw3Stacy Hutton Johnson4Jeremiah Morelock5Christopher S. Lee6Boston College William F. Connell School of NursingCenter for Research and Education, Benjamin Rose Institute On AgingCardiac Transplantation Program, Tufts Medical CenterTufts University School of MedicineCanopy Consultants Inc.Boston College William F. Connell School of NursingBoston College William F. Connell School of NursingAbstract 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.https://doi.org/10.1186/s40814-023-01249-7Heart failureCouplesDyadic healthCommunicationCollaborationSupport |
| spellingShingle | Karen S. Lyons Carol J. Whitlatch Amanda R. Vest Jenica N. Upshaw Stacy Hutton Johnson Jeremiah Morelock Christopher S. Lee Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure Pilot and Feasibility Studies Heart failure Couples Dyadic health Communication Collaboration Support |
| title | Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure |
| title_full | Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure |
| title_fullStr | Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure |
| title_full_unstemmed | Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure |
| title_short | Taking Care of Us© (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure |
| title_sort | taking care of us c tcu study protocol feasibility and acceptability of a dyadic intervention for couples living with heart failure |
| topic | Heart failure Couples Dyadic health Communication Collaboration Support |
| url | https://doi.org/10.1186/s40814-023-01249-7 |
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