N/A
N=60
Health Coaching to Improve Self-Management in Thoracic Transplant Candidates
Self-management · Lung Transplant · Heart Transplant
Bottom Line
View on ClinicalTrials.gov: NCT03150095 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Dec 2022
Primary outcome: Primary: Score on Follow-up Self-Management Ability Scale (SMAS-30) — 75.06; 71.47 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Health coaching (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on Follow-up Self-Management Ability Scale (SMAS-30) |
75.06; 71.47 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Subject is on heart or lung transplant waiting list
Exclusion Criteria
- Under 18 years old
Data sourced from ClinicalTrials.gov (NCT03150095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.