Health Coaching to Improve Self-Management in Thoracic Transplant Candidates

NCT03150095 | Completed Results DMC

• 2 other identifiers: 17-003921K23HL128859
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Score on Follow-up Self-Management Ability Scale (SMAS-30)

  The 30 Item Self-Management Ability Scale (SMAS-30) measures self-management based on questions from 6 subsets of Taking Initiatives, Investment Behavior, Variety, Multifunctionality, Self-efficacy, and Positive Frame of Mind. These are totaled into a scale ranging from 0-100. Higher scores indicate better self-management ability.

  12-16-week follow-up

Study Arms (2)

Health coaching

EXPERIMENTAL

Patients will work with a health coach to improve self-management skills

Behavioral: Health coaching

Control

NO INTERVENTION

Patients will receive usual pre-transplant education to improve self-management skills

Interventions

Health coaching BEHAVIORAL

Patients will work with a health coach by telephone

Health coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is on heart or lung transplant waiting list

You may not qualify if:

• Under 18 years old

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Dr. Cassie Kennedy
• Organization: Mayo Clinic

kennedy.cassie@mayo.edu

507-266-3958

Study Officials

• Cassie C Kennedy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 11, 2017
• Study Start: October 25, 2019
• Primary Completion: September 7, 2021
• Study Completion: November 2, 2021
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)