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

NCT07361159 | Recruiting

• 1 other identifier: 25-009890
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wellbeing

Keywords

Health and Wellness Coaching; Thoracic Transplant; Caregivers; Caregiver Burden; Caregiver Self-efficacy

Outcome Measures

Primary Outcomes (2)

• Caregiver Burden Scale (CBS)

  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

  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

Study Arms (1)

Health and Wellness Coaching

EXPERIMENTAL

All caregiver participants will be in arm 1 and receive the health and wellness coaching intervention.

Behavioral: Health and Wellness Coaching

Interventions

Health and Wellness Coaching BEHAVIORAL

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.

Also known as: Health Coaching, Wellness Coaching

Health and Wellness Coaching

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Interventions

Health

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Central Study Contacts

Cassie Zell, MA, NBC-HWC

CONTACT

507-266-7765; zell.cassandra@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 22, 2026
• Study Start: November 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)