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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
230
Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.
Mayo Clinic
Jacksonville, Florida, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
NOT_YET_RECRUITINGChange 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.
Time frame: 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.
Time frame: Baseline, 12-16 Week Follow-up
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.
Time frame: 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.
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Time frame: 12-16 Week Follow-up