[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05426200":3,"trial-entities:NCT05426200":117,"trial-summary:NCT05426200":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":42,"sex":51,"minimum_age":52,"maximum_age":16,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":61,"locations":64,"central_contacts":109,"overall_officials":112,"references":115,"see_also_links":116},"NCT05426200","21-002675","Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates","RECRUITING","2027-01","2026-03","2026-04-03","2023-01-25","Mayo Clinic","OTHER",true,"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.",null,[18],"Lung Transplant",[20],"Self-management","INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},230,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Health Coaching","Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.",[31],[35,39],{"measure":36,"description":37,"timeFrame":38},"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",{"measure":40,"description":41,"timeFrame":38},"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.",[43,47],{"measure":44,"description":45,"timeFrame":46},"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.","Post-Transplant Follow-up, on Average 1 Year",{"measure":48,"description":49,"timeFrame":50},"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","ALL","18 Years",false,{"inclusion":55,"exclusion":57,"raw_text":60},[56],"Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington",[58,59],"Under 18 years old","Non-English speaking, nonverbal, or extremely hard of hearing","Inclusion Criteria:\n\n* Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington\n\nExclusion Criteria:\n\n* Under 18 years old\n* Non-English speaking, nonverbal, or extremely hard of hearing",[62,63],"ADULT","OLDER_ADULT",[65,79,95],{"facility":12,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":76},"Jacksonville","Florida","32224","United States",[71],{"name":72,"role":73,"phone":74,"email":75},"Sadia Z Shah, MD, MBA","CONTACT","904-956-3271","shah.sadia@mayo.edu",{"lat":77,"lon":78},30.33218,-81.65565,{"facility":12,"status":7,"city":80,"state":81,"zip":82,"country":69,"contacts":83,"geoPoint":92},"Rochester","Minnesota","55902",[84,88],{"name":85,"role":73,"phone":86,"email":87},"Cassie C Kennedy, MD","507-266-3958","kennedy.cassie@mayo.edu",{"name":89,"role":73,"phone":90,"email":91},"Cassie L Zell, MA","507-266-7765","zell.cassandra@mayo.edu",{"lat":93,"lon":94},44.02163,-92.4699,{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":69,"contacts":101,"geoPoint":106},"University of Washington","NOT_YET_RECRUITING","Seattle","Washington","98195",[102],{"name":103,"role":73,"phone":104,"email":105},"Erika D Lease, MD","206-598-5668","edlease@uw.edu",{"lat":107,"lon":108},47.60621,-122.33207,[110,111],{"name":85,"role":73,"phone":86,"email":87},{"name":89,"role":73,"phone":90,"email":91},[113],{"name":85,"affiliation":12,"role":114},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":118,"biomarkers":120},[119],"Lung Transplantation",[],{"nct_id":4,"found":14,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This interventional study plans to enroll 230 participants to compare health coaching with usual care.","completed","Health Coaching for Lung Transplant Candidates","This study is testing if individual health coaching can improve how lung transplant candidates feel and cope. You would work with a health coach by phone for up to 12 sessions over 12-16 weeks. This is compared to standard care, which includes pre-transplant education. The study aims to see if health coaching improves your scores on questionnaires about your breathing problems and emotional well-being. You can join if you are 18 or older, speak English, and are on the waiting list or deferred for a lung transplant at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington. The study is currently unclear on its recruitment status.","Your progress will be measured at the beginning of the study and again after 12-16 weeks.",107,"You would participate in up to 12 telephone health coaching sessions over a 12-16 week period.","Not stated in the trial record.",[31],"v2"]