Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates
ConditionLung Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington
Disqualifiers
Under 18 years old
Non-English speaking, nonverbal, or extremely hard of hearing
Trial design
Design model
Parallel
Treatments tested in this trial
Health Coaching
BehavioralPatients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Health CoachingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 12-16 Week Follow-up2
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-upSecondary outcomes
1
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 Year2
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.
Time frame
12-16 Week Follow-upSponsors and contacts
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Source ClinicalTrials.gov