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

Not Applicable

Recruiting

• Conditions: Lung Transplant
• Interventions: Behavioral: Health Coaching

• Registration Number: NCT05426200
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-21
• Study Start: 2023-01-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington

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Exclusion Criteria

• Under 18 years old
• Non-English speaking, nonverbal, or extremely hard of hearing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Coaching	Health Coaching	Patient will work with a health coach to improve self-management skills, and receive usual pre-transplant education.

Primary Outcome Measures

Name	Time	Method
Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain	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	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.

Secondary Outcome Measures

Name	Time	Method
Intervention Feasibility and Acceptability via Qualitative Surveys and Interviews	12-16 Week Follow-up	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.
Post-Transplant Quality of Life Chronic Respiratory Disease Questionnaire (CRQ) Composite	Post-Transplant Follow-up, on Average 1 Year	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.

Trial Locations

Locations (2)

University of Washington; 🇺🇸 Seattle, Washington, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States