Health and Wellness Coaching to Improve Thoracic Transplant Caregiver Self-Efficacy

January 28, 2026 updated by: Cassie C. Kennedy, M.D., Mayo Clinic
This is a pilot study examining the effects of telephonic health and wellness coaching on self-efficacy and caregiving burden for caregivers of patients awaiting heart or lung transplant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Cassie Kennedy, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Primary caregivers of patients listed (active, deferred, or temporarily inactive) for lung, heart/lung, or heart transplantation at Mayo Clinic in Rochester

Exclusion Criteria:

  • Individuals younger than 18 years old
  • Individuals who are non-English speaking, non-verbal, or extremely hard of hearing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health and Wellness Coaching
All caregiver participants will be in arm 1 and receive the health and wellness coaching intervention.
Behavioral: Health and Wellness Coaching
Participants will receive health and wellness coaching. Coaching sessions will occur via telephone with a National Board-Certified Health and Wellness Coach (NBC-HWC). Sessions will be motivational interview based and will be up to 30 minutes in length. Participants can receive up to 8 coaching sessions within 10 weeks.
Other Names:
  • Health Coaching
  • Wellness Coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Burden Scale (CBS)
Time Frame: Completed at baseline and at study completion; 10 weeks after enrollment

The CBS is a 21-item questionnaire where caregivers rate responses based on perceived level of burden on a 0-4 Likert scale. Scores are summed with higher scores indicating greater caregiver burden.

No or minimal burden: 0 to 20 Mild to moderate burden: 21 to 40 Moderate to severe burden: 41-60 Severe burden: 61 to 88
Completed at baseline and at study completion; 10 weeks after enrollment
Caregiver Self-Efficacy Scale
Time Frame: Completed at baseline and at study completion; 10 weeks after enrollment
The Caregiver Self-Efficacy scale is a an 8-item questionnaire where caregivers rate their level of confidence on their ability to keep up with their own activities and caregiving situations using a 0-10 scale with 10 being totally confident. Total self-efficacy score is the mean of the eight items with higher scores indicating higher self-efficacy.
Completed at baseline and at study completion; 10 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-009890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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