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NCT Number: NCT07361159

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

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.

Recruiting

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Key information

Conditions

Wellbeing Behavior Behavioral Symptoms Caregiver Burden Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Cassie Kennedy, MD, MS

PRINCIPAL_INVESTIGATOR

Cassie Zell, MA, NBC-HWC

CONTACT

[email protected]

507-266-7765

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Health Coaching, Wellness Coaching

Primary outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassie Zell, MA, NBC-HWC

CONTACT

[email protected]

507-266-7765

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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