Health Coaching to Improve Self-Management in Thoracic Transplant Candidates
Public ClinicalTrials.gov record NCT03150095. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03150095
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 24, 2019
- Primary completion
- Sep 6, 2021
- Completion
- Nov 1, 2021
- Last update posted
- Dec 20, 2022
2019 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03150095, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 20, 2022 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03150095 live on ClinicalTrials.gov.