[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06386198":3,"trial-entities:NCT06386198":108,"trial-summary:NCT06386198":112},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":64,"locations":66,"central_contacts":100,"overall_officials":104,"references":106,"see_also_links":107},"NCT06386198","23-40699","HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients","RECRUITING","2030-06-30","2026-08","2026-08-11","2024-03-03","University of California, San Francisco","OTHER",false,"The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent\u002Fyoung adult liver transplant patients and measure acceptability and feasibility according to RE-AIM.",null,[18],"Liver Transplant; Complications",[20,21],"Health Advocate","Patient Navigator","INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":20,"description":32,"armGroupLabels":33,"otherNames":35},"BEHAVIORAL","The Health Advocate intervention will include helping pediatric liver transplant recipients and their families address unmet household social needs (e.g., food insecurity), improve patient-provider communication, and enhance care coordination.",[34],"Intervention",[21],[37],{"measure":38,"description":39,"timeFrame":40},"Changes in patient experience","The investigators will administer a survey of patient experience at study enrollment and at the end of the intervention to assess for changes in patient experience with the transplant team. These questions will focus on experiences receiving transplant care, experiences discussing social needs with the transplant team, and overall subjective assessment of the transplant recipient's overall health.","Baseline and 180 days",[42,45,49],{"measure":43,"description":44,"timeFrame":40},"Change in medication adherence using MLVI","Medication level variability index (MLVI) defined as the standard deviation of at least 3 outpatient tacrolimus trough levels (binary \\>\u002F=2.0 or \\\u003C2.0). The investigators will assess this at study entry and again at 180 days.",{"measure":46,"description":47,"timeFrame":48},"The quality of health advocate interactions with the participants, healthcare team, and community-based resources.","The Health Advocate will keep a detailed journal entry after each encounter and certain Health Advocate interactions will be recorded. The investigators will qualitatively analyze these journal entries and recordings to identify what functions the health advocate undertook.","180 days",{"measure":50,"description":51,"timeFrame":48},"A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention.","The investigators will conduct in-depth interviews with the patient participant and clinical team members to assess overall satisfaction with the intervention.","ALL","18 Years","25 Years",{"inclusion":56,"exclusion":57,"raw_text":63},[],[58,59,60,61,62],"Patient has significant cognitive impairment.","Does not meet age criteria","Patient is a ward of the state.","Non-English, non-Spanish speakers.","Non-US residents.","Inclusion Criteria:\n\n1. Patient has received a liver transplant \\>1 year ago\n2. Study team has screened patient and discussed with the primary transplant practitioner that patient may benefit from the Health Advocate program.\n3. Patient has an unmet social risk (e.g., food insecurity) or MLVI \\>\u002F= 2.0.\n4. Patient will be transferred to adult transplant team in \\\u003C6 months.\n5. Patient can read and write English or Spanish\n6. Patient is between 18-25 years old and can provide informed consent.\n7. Patient has a working phone and smart device capable of video and\u002For audio virtual visits via Zoom.\n\nExclusion Criteria:\n\n* Patient has significant cognitive impairment.\n* Does not meet age criteria\n* Patient is a ward of the state.\n* Non-English, non-Spanish speakers.\n* Non-US residents.",[65],"ADULT",[67,85],{"facility":68,"status":7,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":82},"University of California San Francisco","San Francisco","California","94158","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Emily Stekol","CONTACT","415-502-3190","emily.stekol@ucsf.edu",{"name":80,"role":81},"Sharad Wadhwani, MD, MPH","PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},37.77493,-122.41942,{"facility":86,"status":7,"city":87,"state":88,"zip":89,"country":72,"contacts":90,"geoPoint":97},"Children's Healthcare of Atlanta","Atlanta","Georgia","30345",[91,95],{"name":92,"role":76,"phone":93,"email":94},"Saira Ali","404-849-3903","Saira.ali@choa.org",{"name":96,"role":81},"Nitika Gupta",{"lat":98,"lon":99},33.749,-84.38798,[101],{"name":80,"role":76,"phone":102,"email":103},"510-428-3058","sharad.wadhwani@ucsf.edu",[105],{"name":80,"affiliation":12,"role":81},[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Liver Transplantation",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is a pilot study, meaning it's a small-scale test of the Health Advocate intervention. It is open-label, so everyone involved will know they are receiving the intervention. There will be 20 participants.","completed","HEAL-Tx: Health Advocate for Adolescent Liver Transplant Recipients","This study is testing a program called \"Health Advocate\" (HEAL-Tx) to see if having a dedicated advocate can help young people (ages 18-25) who have had a liver transplant transition smoothly to adult care. The Health Advocate will help with things like finding food or housing, improving communication with doctors, and coordinating care. We want to see if this program is practical and well-received by patients and their families. To join, you must have received a liver transplant over a year ago, be between 18 and 25 years old, and have a social need (like food insecurity) or a certain risk score. The study plans to enroll 20 participants, but the current recruitment status is unclear.","Your patient experience will be measured at baseline and again after 180 days.",116,"You will participate in the Health Advocate program. Your experience will be measured at the beginning of the study and again after 180 days.","Not stated in the trial record.",[20],"v2"]