[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05900687":3,"trial-entities:NCT05900687":89,"trial-summary:NCT05900687":93},{"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":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":45,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":70,"locations":73,"central_contacts":82,"overall_officials":83,"references":87,"see_also_links":88},"NCT05900687","62297","Developing and Testing Mobile Health Question Prompt List in Gastroesophageal Reflux Disease","Developing, Refining, and Testing a Mobile Health Question Prompt List in Gastroesophageal Reflux Disease","NOT_YET_RECRUITING","2028-06-01","2023-05","2023-06-12","2023-07-01","Stanford University","OTHER",false,"More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his\u002Fher physician about GERD. The first aim is to gather feedback about daily challenges of living with GERD. The second aim is to gather feedback on the prototype app. The third (primary) aim of this project is to develop the mHealth application and measure differences in patient activation when used compared to standard of care.",null,[19,20],"Gastroesophageal Reflux","Patient Activation",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[25],"NA",{"count":27,"type":28},150,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"BEHAVIORAL","Use of mHealth Question Prompt List app","mHealth Question Prompt List app that facilitates in asking questions with a physician during a consultation specific to GERD",[35],"mHealth app (Aim 3)",[37],"Esophagus-Qs",[39,43],{"measure":40,"description":41,"timeFrame":42},"Patient Activation Measure Scale Score","Patient Activation Measure is a measure of how much activation (knowledge and confidence) participants have in managing their health.","month 3",{"measure":40,"description":41,"timeFrame":44},"month 6",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Pill Count","measures medication adherence","months 3 and 6",{"measure":51,"description":52,"timeFrame":49},"12-item Short Form Survey","patient survey that measures health related quality of life",{"measure":54,"description":55,"timeFrame":49},"Gerd-Q","patient survey that measures symptom severity of GERD","ALL","18 Years","100 Years",{"inclusion":60,"exclusion":66,"raw_text":69},[61,62,63,64,65],"clinical diagnosis of GERD","GerdQ score of \\>=8","documented PPI use for GERD","internet access at home or computer\u002Fmobile device","ability to provide written or e-consent.",[67,68],"Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)","non-English speaking patients","Inclusion Criteria:\n\n* clinical diagnosis of GERD\n* GerdQ score of \\>=8\n* documented PPI use for GERD\n* internet access at home or computer\u002Fmobile device\n* ability to provide written or e-consent.\n\nExclusion Criteria:\n\n* Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)\n* non-English speaking patients",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":13,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"Stanford","California","94305","United States",{"lat":80,"lon":81},37.42411,-122.16608,[],[84],{"name":85,"affiliation":13,"role":86},"Afrin N Kamal, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Gastroesophageal Reflux Disease",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an interventional study, meaning participants will receive a specific intervention (the mHealth QPL app). It aims to enroll 150 participants.","completed","Mobile Health App for Gastroesophageal Reflux Disease (GERD)","This study is testing a mobile health (mHealth) app called the Question Prompt List (QPL) for people with Gastroesophageal Reflux Disease (GERD). The app is designed to help you ask questions to your doctor during appointments about your GERD. Researchers want to see if using this app helps you feel more involved in your healthcare decisions. You may be able to join if you are 18 to 100 years old, have a GERD diagnosis, a specific GERD symptom score (GerdQ >=8), use proton pump inhibitors (PPIs) for GERD, and have internet access. The study will measure how involved you feel in your care at 3 and 6 months. This study is currently unclear on its recruitment status and plans to enroll 150 participants.","Participants will be followed for 6 months, with measurements taken at 3 and 6 months.",123,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]