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

NCT05426200 | Recruiting DMC

• 1 other identifier: 21-002675
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Transplant

Keywords

Self-management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Post-Transplant Quality of Life Chronic Respiratory Disease Questionnaire (CRQ) Composite

  Post-Transplant Follow-up, on Average 1 Year

• Intervention Feasibility and Acceptability via Qualitative Surveys and Interviews

  12-16 Week Follow-up

Study Arms (2)

Health Coaching

EXPERIMENTAL

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

Behavioral: Health Coaching

Control

NO INTERVENTION

Patients will receive usual pre-transplant education.

Interventions

Health Coaching BEHAVIORAL

Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.

Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

NOT YET RECRUITING

Study Officials

• Cassie C Kennedy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassie C Kennedy, MD

CONTACT

507-266-3958; kennedy.cassie@mayo.edu

Cassie L Zell, MA

CONTACT

507-266-7765; zell.cassandra@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 21, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)