[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658969":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":47,"studyPopulation":38,"armGroups":48,"interventions":55,"overallOfficials":61,"centralContacts":66,"locations":72,"responsibleParty":80,"collaborators":38,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":38,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":38,"enrollmentInfo":91,"targetDuration":38,"studyType":94,"phases":95,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":111,"whyStopped":38,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Wolfson Medical Center","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":38},[9,13,17,21,24,28],{"measure":10,"description":11,"timeFrame":12},"Feasibility and usage rates of the digital assistant","Feasibility will be assessed by the percentage of follow-up questionnaire respondents who report using the GPT-based digital assistant during the treatment process. Use will be assessed by a yes\u002Fno question in the study-specific, non-validated follow-up questionnaire. The number of respondents and the number of enrolled participants without follow-up data will also be reported.","From enrollment to follow-up at 2 weeks",{"measure":14,"description":15,"timeFrame":16},"Frequency of digital assistant use","Frequency of use will be assessed among participants who report using the GPT-based digital assistant, as assessed using the study-specific, non-validated follow-up questionnaire. Participants select one of four categories: once, 2-3 times, 4-5 times, or more than 5 times. The percentage of users in each category will be reported.","From enrollment through follow-up at 2 weeks",{"measure":18,"description":19,"timeFrame":20},"Patient satisfaction, usability, and perceived usefulness","Patient experience will be assessed among participants who used the GPT-based digital assistant, using three items in the study-specific, non-validated follow-up questionnaire: ease of use, perceived usefulness of the information, and overall satisfaction. Each item is rated from 1 (do not agree at all) to 5 (strongly agree). Higher scores indicate greater ease of use, usefulness, or satisfaction. Each item will be reported separately; no combined score will be calculated.","at 2 weeks after enrollment",{"measure":22,"description":23,"timeFrame":20},"Patient-reported decision not to contact medical staff after using the assistant","The percentage of assistant users who report an occasion when they considered contacting medical staff but felt that contact was unnecessary after receiving a response from the GPT-based digital assistant will be assessed using the study-specific, non-validated follow-up questionnaire. Response options are yes, no, and unsure. The distribution of responses will be reported.",{"measure":25,"description":26,"timeFrame":27},"Perceived support and availability of answers","Perceived support will be assessed using two items in the study-specific, non-validated questionnaire: having sufficient support to cope with the process, and being able to obtain answers to questions when needed. Each item is rated from 1 (do not agree at all) to 5 (strongly agree), with higher scores indicating greater perceived support or availability of answers. Baseline and follow-up responses will be reported separately for each item.","At baseline before first use and at 2 weeks after enrollment.",{"measure":29,"description":30,"timeFrame":27},"Self-reported comprehension of treatment instructions","Self-reported comprehension will be assessed using three items in the study-specific, non-validated questionnaire addressing how and when to take medications, expected symptoms, and when to seek medical assistance. Each item is rated from 1 (do not agree at all) to 5 (strongly agree), with higher scores indicating greater perceived comprehension. Baseline and follow-up responses will be reported separately for each item.",[32,35],{"measure":33,"description":34,"timeFrame":20},"Participant suggestions for improvement","Suggestions for improvement will be collected using the open-ended follow-up question asking participants what one thing they would change or improve in the GPT-based digital assistant. Responses will be summarized qualitatively and grouped into recurring themes.",{"measure":36,"description":37,"timeFrame":20},"Insights into integration into reproductive care","An exploratory qualitative synthesis of participant suggestions for improvement will identify themes potentially relevant to integrating the digital assistant into routine reproductive care. This assessment will use responses to the open-ended follow-up question asking what participants would change or improve in the assistant and will not generate a numerical score.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"NA","SINGLE_GROUP","This is a prospective, single-arm, open-label feasibility study. All enrolled participants undergoing treatment for induced or missed abortion will receive access to a Hebrew-language GPT-based digital assistant from enrollment until their follow-up visit, alongside standard clinical care. Participants may use the assistant voluntarily throughout this period. The study will assess feasibility, usage, usability, acceptability, and patient-reported experience. There is no randomization or comparator group.","SUPPORTIVE_CARE",{"masking":45,"maskingDescription":46,"whoMasked":38},"NONE","No masking is used. Participants and investigators are aware of access to the GPT-based digital assistant.","Medication abortion and treatment for missed abortion can be emotionally and physically demanding experiences. Patients may experience confusion, anxiety, and isolation during the home phase of treatment, and clinical instructions may be difficult to understand or follow during moments of stress or pain. Accessible, timely, and patient-centered information may help support patients throughout this process.\n\nThis prospective, single-arm, open-label, interventional feasibility study will assess the feasibility, usability, and acceptability of a GPT-based digital assistant designed to support patients undergoing induced abortion or treatment for missed abortion. The assistant is designed to provide empathetic, guideline-based information in Hebrew, tailored to the clinical protocols used in the clinic. It provides information in plain language and directs patients to the clinic or emergency care when appropriate.\n\nApproximately 100 Hebrew-speaking patients undergoing induced abortion at up to 9 weeks of gestation or treatment for missed abortion at up to 12 weeks of gestation at Wolfson Medical Center will be enrolled during their initial clinic visit. After providing informed consent, participants will receive access to the digital assistant alongside standard clinical care. They may use the assistant as needed throughout the treatment process until the follow-up visit. There is no randomization or comparator group.\n\nBaseline data will include demographic characteristics, previous abortion experience, and expectations regarding the digital assistant. Follow-up data will be collected through a study-specific questionnaire assessing assistant use, ease of use, usefulness, overall satisfaction, self-reported emotional state, perceived support, comprehension of treatment instructions, whether participants contacted medical staff and the type of contact, and whether they decided not to contact medical staff after receiving an answer from the assistant. Open-ended feedback will also be collected.\n\nThe study will evaluate feasibility and usage rates, patient satisfaction, perceived emotional support, and comprehension of treatment instructions. Participant feedback will be used to identify opportunities for improvement and explore potential integration into reproductive care.\n\nThe assistant is intended to supplement standard clinical information and support, rather than replace professional medical assessment or emergency services. Study data will be anonymized and stored securely in accordance with the approved protocol.",[49],{"label":50,"type":51,"description":52,"interventionNames":53},"GPT-Based Digital Assistant Support","EXPERIMENTAL","Participants undergoing treatment for induced or missed abortion will receive access to a Hebrew-language GPT-based digital assistant upon enrollment, in addition to standard clinical care. Participants may use the assistant as needed until their follow-up visit. The assistant is designed to provide plain-language information about the treatment process, clarify clinical instructions, offer emotional support, and direct participants to the clinic or emergency services when appropriate. It supplements, rather than replaces, professional medical care.",[54],"Other: GPT-Based Digital Assistant",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":38},"OTHER","GPT-Based Digital Assistant","a digital assistant based on GPT (Generative Pre-trained Transformer) technology, trained specifically to provide empathetic, medically accurate, and guideline-based responses in Hebrew, tailored to the clinical protocols used in our clinic. The assistant is designed to support patients throughout the medication abortion or missed abortion process, from the time of first medication until the follow-up visit. It offers culturally sensitive information in plain language, referring to the clinic or emergency care as needed.",[50],[62],{"name":63,"affiliation":64,"role":65},"Liron Koren Arkin","Edith Wolfson Medical Center","PRINCIPAL_INVESTIGATOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":38,"email":71},"Liron Koren Arkin, MD","CONTACT","+972-545960296","lrnkoren@gmail.com",[73],{"facility":64,"status":38,"city":74,"state":75,"zip":38,"country":76,"countryCode":77,"cosmosGeoPoint":38,"geoPoint":38,"contacts":78},"Holon","Central District","Israel","IL",[79],{"name":68,"role":69,"phone":70,"phoneExt":38,"email":71},{"type":65,"investigatorFullName":63,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Senior OB\u002FGYN","100658969","gpt-based-digital-assistant-support-during-treatment-for-induced-abortion-or-missed-abortion-100658969",false,"NCT07856940","GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion","Feasibility and Usability of a GPT-Based Digital Assistant for Patients Undergoing Treatment for Induced Abortion or Missed Abortion: A Prospective Single-Arm Interventional Study","Inclusion Criteria:\n\n* Undergoing medical abortion (up to 9 weeks gestation) or treatment for missed abortion (up to 12 weeks gestation)\n* Hebrew-speaking\n* Signed informed consent\n\nExclusion Criteria:\n\n* No access to a smartphone or internet at home\n* Non-Hebrew speakers","FEMALE","18 Years",{"count":92,"type":93},100,"ESTIMATED","INTERVENTIONAL",[40],"We have developed a digital assistant based on GPT (Generative Pre-trained Transformer) technology, trained specifically to provide empathetic, medically accurate, and guideline-based responses in Hebrew, tailored to the clinical protocols used in our clinic.\n\nThe goal of this interventional study is to learn about the feasibility, usability, and acceptability of a GPT-based digital assistant for patients undergoing medication abortion or treatment for missed abortion.\n\nThe study aims to assess use of the digital assistant, patient-reported usability, usefulness and satisfaction, perceived support, comprehension of treatment instructions, and decisions about contacting medical staff.\n\nParticipants already receiving standard care for medication abortion or missed abortion at the clinic will be offered access to the digital assistant immediately after enrollment. They may use the assistant freely at home throughout their treatment process and will complete baseline and follow-up surveys about their experience, emotional state, and any additional contacts with the clinic.",[98,99,100,101],"Missed Abortion","Early Pregnancy Loss","Abortion in First Trimester","Abortion, Medical",[103,104,105,106,99,107,108,109,110],"Medical abortion","Artificial Intelligence","GPT","Missed abortion","Digital Assistant","Chatbot","Feasibility Study","Patient Satisfaction","NOT_YET_RECRUITING","2026-09-28",{"date":114,"type":115},"2026-10-05","ACTUAL",{"date":117,"type":93},"2026-10-01",{"date":119,"type":93},"2027-01-30",{"name":5,"class":6},1]