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RecruitingNCT07361159Updated Jan 30, 2026

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

An interventional study of Health and Wellness Coaching in Wellbeing, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Wellbeing

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Keywords

  • Health and Wellness Coaching
  • Thoracic Transplant
  • Caregivers
  • Caregiver Burden
  • Caregiver Self-efficacy
03

In context

Caregiver Burden

422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.

This study's planned enrollment of 30 is below the median of 73 across 330 interventional studies indexed under Caregiver Burden.

Browse Caregiver Burden studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Individuals younger than 18 years old
  • Individuals who are non-English speaking, non-verbal, or extremely hard of hearing
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralHealth 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.

    Also known as: Health Coaching, Wellness Coaching

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Completed at baseline and at study completion; 10 weeks after enrollment

  2. 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.

    Time frame: Completed at baseline and at study completion; 10 weeks after enrollment

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    • Cassie Zell, MA, NBC-HWC · Contact · zell.cassandra@mayo.edu · 507-266-7765
    • Cassie Kennedy, MD, MS · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07361159
Lead sponsor
Mayo Clinic
Responsible party
Cassie C. Kennedy, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 22, 2026
Start date
Nov 18, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 30, 2026

Study contacts

Cassie Zell, MA, NBC-HWC
Contact
zell.cassandra@mayo.edu
507-266-7765

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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