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

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 Overview

• Status: Recruiting
• Conditions: Lung Transplant
• Intervention / Treatment: Behavioral: Health Coaching

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassie C Kennedy, MD; Phone Number: 507-266-3958; Email: kennedy.cassie@mayo.edu
• Study Contact Backup: Name: Cassie L Zell, MA; Phone Number: 507-266-7765; Email: zell.cassandra@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Contact: Sadia Z Shah, MD, MBA; Phone Number: 904-956-3271; Email: shah.sadia@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Recruiting
      • Mayo Clinic
      • Contact: Cassie C Kennedy, MD; Phone Number: 507-266-3958; Email: kennedy.cassie@mayo.edu
      • Contact: Cassie L Zell, MA; Phone Number: 507-266-7765; Email: zell.cassandra@mayo.edu
  • Washington
    • Seattle, Washington, United States, 98195
      • Not yet recruiting
      • University of Washington
      • Contact: Erika D Lease, MD; Phone Number: 206-598-5668; Email: edlease@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Cassie C Kennedy, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Self-management
• Other Study ID Numbers: 21-002675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No