WellbeingNCT07361159
Health and Wellness Coaching to Improve Thoracic Transplant Caregiver Self-Efficacy
A study testing Health and Wellness Coaching in people with Wellbeing, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wellbeing
- What is being tested?
- Health and Wellness Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals younger than 18 years old
- Individuals who are non-English speaking, non-verbal, or extremely hard of hearing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Cassie Zell, MA, NBC-HWC, 507-266-7765, zell.cassandra@mayo.edu
Cassie Kennedy, MD, MS
About this study
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
- Being tested
- Health and Wellness Coaching
- Keywords
- Health and Wellness Coaching, Thoracic Transplant, Caregivers, Caregiver Burden, Caregiver Self-efficacy
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and Wellness CoachingBehavioural
Also called Health Coaching, 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.
| Study group | Role | What they receive |
|---|---|---|
| Health and Wellness Coaching | Experimental | All caregiver participants will be in arm 1 and receive the health and wellness coaching intervention. Receives: Behavioral: Health and Wellness Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Completed at baseline and at study completion; 10 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start18 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellbeingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cassie C. Kennedy, M.D., Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361159
- Sponsor's protocol ID
- 25-009890
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Wellness Coaching to Improve Thoracic Transplant Caregiver Self-Efficacy
- ClinicalTrials.gov ID
- NCT07361159
- Acronym / sponsor ID
- 25-009890
- Conditions
- Wellbeing
- Keywords
- Health and Wellness Coaching, Thoracic Transplant, Caregivers, Caregiver Burden, Caregiver Self-efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health and Wellness Coaching | Experimental | Behavioral: Health and Wellness CoachingAll caregiver participants will be in arm 1 and receive the health and wellness coaching intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Individuals younger than 18 years old
- Individuals who are non-English speaking, non-verbal, or extremely hard of hearing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health and Wellness CoachingAlso: Health Coaching, Wellness CoachingParticipants 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. | Behavioural | Health and Wellness Coaching |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health and Wellness Coaching in people with Wellbeing, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassie Zell, MA, NBC-HWC (507-266-7765, zell.cassandra@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden Scale (CBS) (time frame: Completed at baseline and at study completion; 10 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.