Lung TransplantNCT05426200
Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates
A study testing Health Coaching in people with Lung Transplant, run by Mayo Clinic at 3 sites in United States.
Trial summary
To examine the effectiveness of an individual health coaching intervention for lung transplant candidates. This intervention will include up to 12 health coaching sessions via phone call over a 12-16 week period. This will be compared to a usual care group the receives pre-transplant care and education alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jan 2023to Jan 2027
- 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
- Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington
Who cannot join
- Under 18 years old
- Non-English speaking, nonverbal, or extremely hard of hearing
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Sadia Z Shah, MD, MBA, 904-956-3271, shah.sadia@mayo.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Cassie C Kennedy, MD, 507-266-3958, kennedy.cassie@mayo.edu
Cassie L Zell, MA, 507-266-7765, zell.cassandra@mayo.edu
- Not yet recruiting
University of Washington
Seattle, Washington, 98195
Erika D Lease, MD, 206-598-5668, edlease@uw.edu
About this study
To examine the effectiveness of an individual health coaching intervention for lung transplant candidates. This intervention will include up to 12 health coaching sessions via phone call over a 12-16 week period. This will be compared to a usual care group the receives pre-transplant care and education alone.
- Conditions
- Lung Transplant
- Being tested
- Health Coaching
- Keywords
- Self-management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Patient will work with a health coach to improve self-management skills, and receive usual pre-transplant education. Receives: Behavioral: Health Coaching |
| Control | No intervention | Patients will receive usual pre-transplant education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain
Participants will complete questions comprising the CRQ Mastery subdomain (7,10,13, and 19) of a 20-item Chronic Respiratory Questionnaire (CRQ) at baseline and after the 12-week intervention. CRQ Mastery subscores measure self-management abilities and range from 1 to 7, with higher scores indicating higher self-efficacy. The minimum clinically important difference is 0.5.
Measured: Baseline, 12-16 Week Follow-up
Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Emotional Function Subdomain
Participants will complete questions comprising the CRQ Emotional Function subdomain (6,9,12,14,16,18, and 20) of a 20-item Chronic Respiratory Questionnaire (CRQ) at baseline and after the 12-week intervention (or 12-16 weeks from baseline). CRQ Emotional Function subscores measure emotional health and range from 1 to 7, with higher scores indicating better emotional health. The minimum clinically important difference is 0.5.
Measured: Baseline, 12-16 Week Follow-up
Secondary outcomes (2)
Post-Transplant Quality of Life Chronic Respiratory Disease Questionnaire (CRQ) Composite
Participants will complete a 20-item Chronic Respiratory Questionnaire (CRQ) at baseline and at three to six months post-transplant. CRQ composite scores measure health-related quality of life and range from 4 to 28, with higher scores indicating better QOL. The minimum clinically important difference is 2.0. The intervention (or control) phase is 12-16 weeks, but patients will be followed until they are one-year post-lung transplant. Since timing of lung transplant is unknown, the timing of this measurement could range from months to several years after enrollment.
Measured: Post-Transplant Follow-up, on Average 1 Year
Intervention Feasibility and Acceptability via Qualitative Surveys and Interviews
Acceptability and feasibility of the intervention will be examined via qualitative surveys (Likert scale rated questions and open-ended questions) and, for a subset of participants, semi-structured qualitative interviews. This qualitative data will assess the timing, duration, and number of health coaching sessions; any technical issues; the degree of therapeutic alliance with the assigned health coach; the participants' opinions of the perceived benefits of the intervention; and participant input regarding any needed changes in the design for future studies.
Measured: 12-16 Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start25 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 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
- Investigators
- Cassie C Kennedy, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426200
- Sponsor's protocol ID
- 21-002675
- Status last verified
- Mar 2026
- First submitted
- 5 May 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates
- ClinicalTrials.gov ID
- NCT05426200
- Acronym / sponsor ID
- 21-002675
- Conditions
- Lung Transplant
- Keywords
- Self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Jun 2022 (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.
To examine the effectiveness of an individual health coaching intervention for lung transplant candidates. This intervention will include up to 12 health coaching sessions via phone call over a 12-16 week period. This will be compared to a usual care group the receives pre-transplant care and education alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health CoachingPatient will work with a health coach to improve self-management skills, and receive usual pre-transplant education. |
| Control | No intervention | –Patients will receive usual pre-transplant education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington
Key exclusion criteria (2 listed)
- Under 18 years old
- Non-English speaking, nonverbal, 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 CoachingPatients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period. | Behavioural | Health Coaching |
Primary outcome
Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain
Time frame: Baseline, 12-16 Week Follow-up
Participants will complete questions comprising the CRQ Mastery subdomain (7,10,13, and 19) of a 20-item Chronic Respiratory Questionnaire (CRQ) at baseline and after the 12-week intervention. CRQ Mastery subscores measure self-management abilities and range from 1 to 7, with higher scores indicating higher self-efficacy. The minimum clinically important difference is 0.5.
Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Emotional Function Subdomain
Time frame: Baseline, 12-16 Week Follow-up
Participants will complete questions comprising the CRQ Emotional Function subdomain (6,9,12,14,16,18, and 20) of a 20-item Chronic Respiratory Questionnaire (CRQ) at baseline and after the 12-week intervention (or 12-16 weeks from baseline). CRQ Emotional Function subscores measure emotional health and range from 1 to 7, with higher scores indicating better emotional health. The minimum clinically important difference is 0.5.
2 secondary outcomes
Post-Transplant Quality of Life Chronic Respiratory Disease Questionnaire (CRQ) Composite
Time frame: Post-Transplant Follow-up, on Average 1 Year
Intervention Feasibility and Acceptability via Qualitative Surveys and Interviews
Time frame: 12-16 Week Follow-up
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 3 Apr 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.
Cassie C Kennedy, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching in people with Lung Transplant, run by Mayo Clinic at 3 sites 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 1 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 C Kennedy, MD (507-266-3958, kennedy.cassie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain (time frame: Baseline, 12-16 Week Follow-up). 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 3 Apr 2026.