Health Coaching
BehavioralPatients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.
NCT Number: NCT05426200
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Mayo Clinic, Jacksonville, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Cassie C Kennedy, MD
CONTACT
Cassie L Zell, MA
CONTACT
Mayo Clinic
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT07516379
Behavior, End Stage Lung Disease
Bethesda, Maryland, United States
View Trial DetailsNCT03886961
Deglutition Disorders, Digestive System Diseases
Gainesville, Florida, United States
View Trial DetailsNCT06033196
Lung Transplant
Phoenix, Arizona, United States
View Trial DetailsNCT06476132
Acute Lung Injury, Bronchial Diseases
Los Angeles, California, United States
View Trial Details