Lung Transplant
Conditions
Keywords
Self-management
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.
Interventions
BEHAVIORALHealth Coaching
Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain | 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. |
| Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Emotional Function Subdomain | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-Transplant Quality of Life Chronic Respiratory Disease Questionnaire (CRQ) Composite | 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. |
| Intervention Feasibility and Acceptability via Qualitative Surveys and Interviews | 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. |
Countries
United States
Contacts
CONTACTCassie C Kennedy, MD
CONTACTCassie L Zell, MA
PRINCIPAL_INVESTIGATORCassie C Kennedy, MD
Mayo Clinic
Outcome results
None listed