Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates

Study Overview
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Brief Summary
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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.

Official Title
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Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates

Conditions
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Lung Transplant

Intervention / Treatment
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* Behavioral: Health Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington Exclusion Criteria: Under 18 years old Non-English speaking, nonverbal, or extremely hard of hearing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Coaching<br>Patient will work with a health coach to improve self-management skills, and receive usual pre-transplant education. | Behavioral: Health Coaching<br>* Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.<br>|
| No Intervention: Control<br>Patients will receive usual pre-transplant education. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 12-16 Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12-16 Week Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management