Health Coaching to Improve Self-Management in Thoracic Transplant Candidates
NCT03150095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2022-12-21
Summary
Ability to adhere to complex medical regimens is critical to achieving successful transplant outcomes, as non-adherent patients suffer graft failure and death following transplantation. Since potential recipients greatly exceed organ availability, identification of candidates who will adhere to complex post-transplant regimens is critically important and emphasized by practice guidelines. When selecting candidates for transplant, physicians try to subjectively predict post-transplant adherence because, although tools exist to measure current adherence, tools that reliably predict future adherence are lacking. Despite rigorous medical and psychosocial screening pretransplant, non-adherence rates are high following transplant. Therefore, the current approach for predicting future non-adherence is suboptimal, subjective, and greatly needs strategies for improvement.
Pre-transplant self-management abilities represent a marker of future adherence post-transplant. Assessing self-management as a means for predicting future adherence has been largely overlooked. Self-management is defined as "taking responsibility for one's own behavior and well-being" and consists of three management tasks: medical condition, emotions, and social roles. Self-management ability can be measured. However, self-management has not been systematically studied in heart and lung transplant patients. Fostering self-management abilities may improve post-transplant outcomes by optimizing not only adherence, but also proven pretransplant risk factors (e.g. frailty and obesity).Self-management abilities may be improved via behavioral interventions such as health coaching.Self-management represents a measurable criterion that could be utilized in pre-transplant screening and serve as a point of intervention for optimizing adherence and pre-transplant risk factors.The overall objective of the proposed research is to improve the knowledge gap regarding self-management (and thereby adherence) in transplant by qualitatively and quantitatively studying patient factors associated with self-management and testing an intervention that may improve self-management.
The investigators hypothesize: Individualized health coaching including strategies to address poor resilience, coping with uncertainty, frailty, and/or negative affect will be an effective therapeutic strategy at improving self-management while in the pre-transplant state.
Specific Aim: To test whether transplant candidates who receive pre transplant health coaching have greater improvement in self-management abilities.
The investigators will conduct a randomized, controlled pilot trial testing the effectiveness of health coaching versus usual care in a heart and lung transplant cohort on self-management abilities (SMAS-30).
Conditions
- Self-management
- Lung Transplant
- Heart Transplant
Interventions
- BEHAVIORAL
-
Health coaching
Patients will work with a health coach by telephone
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH - lead OTHER
Principal Investigators
-
Cassie C Kennedy, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-25
- Primary Completion
- 2021-09-07
- Completion
- 2021-11-02
Countries
- United States
Study Locations
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