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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Coaching | Experimental | Patient will work with a health coach to improve self-management skills, and receive usual pre-transplant education. |
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| Control | No Intervention | Patients will receive usual pre-transplant education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Coaching | Behavioral | Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cassie C Kennedy, MD | Contact | 507-266-3958 | kennedy.cassie@mayo.edu | |
| Cassie L Zell, MA | Contact | 507-266-7765 | zell.cassandra@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cassie C Kennedy, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
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| 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. | 12-16 Week Follow-up |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55902 | United States |
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| University of Washington | Not yet recruiting | Seattle | Washington | 98195 | United States |
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