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

Lung Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426200
• Other study ID #: 21-002675
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: January 2027

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Cassie C Kennedy, MD
• Phone: 507-266-3958
• Email: kennedy.cassie[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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