[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06817213":3,"trial-entities:NCT06817213":105,"trial-summary:NCT06817213":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":52,"sex":65,"minimum_age":66,"maximum_age":15,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":78,"locations":81,"central_contacts":99,"overall_officials":101,"references":103,"see_also_links":104},"NCT06817213","HUM00257119","Patient-Centered Decision Support for Eosinophilic Esophagitis","Patient-Centered Decision Support for Eosinophilic Esophagitis: A Pilot Study","RECRUITING","2026-12","2025-04","2026-03-31","2025-04-16","University of Michigan","OTHER",null,"The study team is conducting this project to learn more about how patients with eosinophilic esophagitis (EoE) like to use and receive educational materials about treatment options and treatment decision making.\n\nThis study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will assess the feasibility and acceptability of the intervention to inform future R01-level studies.\n\nThe study team hypothesize that deploying the intervention will be feasible, and it will demonstrate high acceptability among EoE patients. Additionally, that patients that use the intervention (vs general education about EoE) will report greater treatment knowledge, increased readiness to choose a therapy, adherence to therapy, and follow-up.",[18],"Eosinophilic Esophagitis",[20,21,22,23],"tailored educational materials","general educational materials","online surveys","decision aid","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","General education control","Participants will complete an online survey before reviewing education material for eosinophilic esophagitis, prior to patient's clinical physician's appointment (this appointment is a standard of care visit). Participants will complete a follow-up survey approximately 3 months after the clinic appointment.",[37],"General education control group",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Decision support tool","Participants will complete an online survey before reviewing tailored educational materials for eosinophilic esophagitis prior to patient's clinical physician's appointment (this appointment is a standard of care visit). The intervention is a tailored, electronic decision support intervention with a patient-facing decision aid (DA) with three components-EoE knowledge\u002Feducation, values clarifications, and communication. Tailored feedback from the patient will be given to the patient's provider prior to the visit to facilitate shared decision-making in the visit. Participants will complete a follow-up survey approximately 3 months after the clinic appointment.",[42],"Decision support tool group",[44,48],{"measure":45,"description":46,"timeFrame":47},"Feasibility: measured as the proportion of eligible patients that consent to participate in the study","The study aims to achieve at least 20% consented for eligible patients.","Recruitment period approximately 18 months",{"measure":49,"description":50,"timeFrame":51},"Acceptability: measured on a 4-point Likert scale","Measured on a 4-point Likert-scale (1) Very Unhelpful to (4) Very Helpful. Analyzed as high scores indicate more helpful.","Approximately 4 months",[53,57,59,62],{"measure":54,"description":55,"timeFrame":56},"Effectiveness (within-subjects)","Objective eosinophilic esophagitis knowledge measured on 8 true\u002Ffalse\u002FI don't know questions where wrong or \"I don't know\" answers are given 0 points and correct answers are given 1 point. Minimum points=0 and Maximum points=8","Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit)",{"measure":58,"description":55,"timeFrame":51},"Effectiveness (between-subjects)",{"measure":60,"description":61,"timeFrame":51},"Preparation for Decision Making (PrepDM) scale","Preparation for Decision making (PrepDM scale) score is a 10-item questionnaire and is scored on a 0-100 scale, where higher scores indicate participants being well prepared to make decisions after reviewing a decision aid (DA). The Prep-DM scale may be adapted slightly to meet the needs of the target population and the developed decision support tool.",{"measure":63,"description":64,"timeFrame":51},"Completion rates","Measured as the proportion of people that consented and completed all study measures, the pre-test, post-test, and 3-month follow-up survey","ALL","18 Years",false,{"inclusion":69,"exclusion":72,"raw_text":77},[70,71],"New EoE patient evaluations ≥18 years old at University of Michigan (UM) that have an upcoming outpatient visit in a UM-gastroenterology or allergy \\& immunology clinic,","Able to speak and read English.",[73,74,75,76],"Prisoners and institutionalized individuals due to logistical limitations for use of a web app and follow-up interactions in these populations.","Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)","Patients that are terminally ill","Patients that do not have an email address or reliable access to the internet","Inclusion Criteria:\n\n* New EoE patient evaluations ≥18 years old at University of Michigan (UM) that have an upcoming outpatient visit in a UM-gastroenterology or allergy \\& immunology clinic,\n* Able to speak and read English.\n\nExclusion Criteria:\n\n* Prisoners and institutionalized individuals due to logistical limitations for use of a web app and follow-up interactions in these populations.\n* Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)\n* Patients that are terminally ill\n* Patients that do not have an email address or reliable access to the internet",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":13,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":96},"Ann Arbor","Michigan","48109","United States",[88,93],{"name":89,"role":90,"phone":91,"email":92},"Kelcie Brophy","CONTACT","734-615-0531","kelcieb@umich.edu",{"name":94,"role":95},"Joy Chang, MD, MS","PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},42.27756,-83.74088,[100],{"name":89,"role":90,"phone":91,"email":92},[102],{"name":94,"affiliation":13,"role":95},[],[],{"nct_id":4,"conditions":106,"biomarkers":107},[18],[],{"nct_id":4,"found":109,"summary":110,"prompt_version":119},true,{"design":111,"status":112,"heading":6,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This interventional study plans to enroll 40 participants. It compares two behavioral interventions: general education materials versus a tailored decision support tool.","completed","This study is looking at how people with Eosinophilic Esophagitis (EoE), a chronic allergic inflammatory disease of the esophagus, prefer to receive and use educational materials about their treatment options. Researchers are comparing two approaches: a \"General education control\" where you review standard online materials, and a \"Decision support tool\" where you review tailored online materials. Both groups will complete surveys before and after reviewing the materials, around the time of a regular doctor's appointment. The study aims to enroll 40 participants aged 18 or older who are new EoE patients at the University of Michigan and can read English. The main goals are to see if these educational tools are practical to use and well-liked by patients.","Participants will complete a follow-up survey approximately 3 months after their clinic visit. Acceptability will be measured at approximately 4 months.",118,"You would complete an online survey before reviewing educational materials and then a follow-up survey approximately 3 months later. These activities are timed around a standard doctor's appointment.","Not stated in the trial record.",[34,39],"v2"]