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NCT Number: NCT05426200

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Coaching

Behavioral

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

Primary outcomes

  1. Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain

    Time frame: 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.

  2. Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Emotional Function Subdomain

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Intervention Feasibility and Acceptability via Qualitative Surveys and Interviews

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassie C Kennedy, MD

CONTACT

[email protected]

507-266-3958

Cassie L Zell, MA

CONTACT

[email protected]

507-266-7765

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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