[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635793":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":30,"locations":40,"responsibleParty":99,"collaborators":102,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":18,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":113,"minAge":114,"maxAge":18,"enrollmentInfo":115,"targetDuration":18,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":135,"overallStatus":147,"whyStopped":18,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mobile-based Educational Intervention","EXPERIMENTAL","Participants in the intervention arm will access a mobile-based educational tool that provides concise, culturally appropriate information about prenatal genetic screening prior to their clinical visit. Immediately after viewing the intervention, participants will complete an online, 6-question acceptability survey. Participants will then complete a one-time structured quantitative telephone interview within one hundred sixty-eight hours (seven days) of their clinician visit to assess their experience with the intervention and to measure decisional self-efficacy. A select subset of participants will participate in an additional qualitative telephone interview to assess the efficacy and usability of the intervention.",[13],"Behavioral: Mobile-based Educational Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","Participants in the standard-of-care arm will receive routine clinical care, including the usual information and counseling provided by clinicians regarding prenatal genetic screening. Participants will complete a one-time structured quantitative telephone interview within one hundred sixty-eight hours (seven days) of their clinician visit to assess their experience being offered prenatal genetic screening and measure decisional self-efficacy.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","A mobile-based informational tool that participants will access through a Quick Response (QR) code prior to the clinical encounter in which they will be offered prenatal genetic screening. This tool will provide clear and concise information about prenatal genetic screening to support pregnant participants in making an informed decision.",[9],[25,28],{"name":26,"affiliation":5,"role":27},"Marsha Michie, PhD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":27},"Megan Allyse, PhD",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Sabina Rubeck, MPH","CONTACT","216-368-2547","sabina.rubeck@case.edu",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Harlie Custer, MA, MPH","(216) 368-5914","harlie.custer@case.edu",[41,63,81],{"facility":42,"status":18,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Zuckerberg Chan San Francisco General Hospital","San Francisco","California","94158","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-122.41942,37.77493,{"lat":52,"lon":51},[55,59],{"name":56,"role":33,"phone":57,"phoneExt":18,"email":58},"Miriam Kuppermann, MPH, PhD","415-502-4089","miriam.kuppermann@ucsf.edu",{"name":60,"role":33,"phone":61,"phoneExt":18,"email":62},"Kimberly Coleman-Phox, MPH","415-476-6406","kimberly.coleman-phox@ucsf.edu",{"facility":64,"status":18,"city":65,"state":66,"zip":67,"country":46,"countryCode":47,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"University of Florida Health","Jacksonville","Florida","32209",{"type":49,"coordinates":69},[70,71],-81.65565,30.33218,{"lat":71,"lon":70},[74,78],{"name":75,"role":33,"phone":76,"phoneExt":18,"email":77},"Niamh Condon, DO, FACOOG","904-383-1037","Niamh.Condon@jax.ufl.edu",{"name":79,"role":33,"phone":18,"phoneExt":18,"email":80},"Julie Nowak","julie.nowak@jax.ufl.edu",{"facility":82,"status":18,"city":83,"state":84,"zip":85,"country":46,"countryCode":47,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"University of North Carolina","Chapel Hill","North Carolina","27599",{"type":49,"coordinates":87},[88,89],-79.05584,35.9132,{"lat":89,"lon":88},[92,96],{"name":93,"role":33,"phone":94,"phoneExt":18,"email":95},"Neeta Vora, MD","(984) 974-2131","Neeta_vora@med.unc.edu",{"name":97,"role":33,"phone":18,"phoneExt":18,"email":98},"Amber Ivins, MSCR","amber_ivins@med.unc.edu",{"type":27,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Marsha Michie","Associate Director, Department of Bioethics, Bioethics Center for Community Health ANd Genomic Equity (CHANGE), School of Medicine",[103],{"name":104,"class":105},"National Human Genome Research Institute (NHGRI)","NIH","100635793","supporting-just-in-time-consent-for-prenatal-screening-the-inform-study-100635793",false,"NCT07557303","Supporting Just-In-Time Consent for Prenatal Screening: The INFORM Study","Inclusion Criteria:\n\n* Currently pregnant and receiving care at a participating collaborative site - University of North Carolina, Chapel Hill; Zuckerberg Chan San Francisco General Hospital; University of Florida Health, Jacksonville.\n* 18 years of age and older\n* Able to read, speak, and understand English or Spanish\n* Has not previously been offered prenatal genetic screening for the current pregnancy\n* 24 weeks (6 months) gestational age or less\n\nExclusion Criteria:\n\n* Not pregnant, not a patient at a partner clinical site\n* Younger than 18 years of age\n* Not being able to read, speak, and understand English or Spanish\n* Has previously been offered prenatal genetic screening for the current pregnancy\n* Greater than 24 weeks gestational age (6 months)",true,"FEMALE","18 Years",{"count":116,"type":117},1400,"ESTIMATED","INTERVENTIONAL",[120],"NA","This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening. The intervention is a short set of information cards about screening. This intervention is for pregnant participants. They will use the intervention on their mobile phone before they see their doctor.\n\nThe study has one main question:\n\n* Do participants who use the intervention feel more confident when they make a decision about screening?\n\nResearchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor.\n\nWhat will participants do?\n\n* Participants must be pregnant. They will sign up for the study before their first doctor's visit for their pregnancy. This is the visit where their doctor usually talks with them about screening.\n* Some participants will use the intervention before their first doctor's visit. Other participants will not use it.\n* All participants will talk with a researcher on the phone after their first doctor's visit.\n* Participants who use the intervention will answer a short survey on their phone.\n* A few participants who use the intervention will talk with a researcher a second time on the phone.",[123,124,125,126,127,128,129,130,131,132,133,134],"Delivery of Health Care","Genetic Testing","Humans","Pregnancy","Noninvasive Prenatal Testing","Informed Consent","Internet-Based Intervention","Self Efficacy","Pregnant People","Decision Making","Health Education","Patient Education as Topic\u002FMethod",[136,137,138,139,140,141,142,143,144,145,146],"Non-invasive prenatal screening (NIPS)","Non-Invasive Prenatal Testing (NIPT)","Cell-free DNA (cfDNA)","Prenatal genetic screening","Informed consent","Decision making","Surveys and Questionnaires","Informed choice","Educational intervention","Decision Regret","Decision Satisfaction","NOT_YET_RECRUITING","2026-06-30",{"date":150,"type":151},"2026-07-01","ACTUAL",{"date":153,"type":117},"2026-08-01",{"date":155,"type":117},"2028-06-30",{"name":5,"class":6},3]