An interventional study of Mobile-based Educational Intervention in Delivery of Health Care, Genetic Testing and Humans, sponsored by Case Western Reserve University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Health services research
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.
The study has one main question:
Researchers will compare participants who use the intervention to participants who do not. All participants will have their usual care when they visit their doctor.
What will participants do?
481 studies on the registry are indexed under Health Education; 110 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 132 across 450 interventional studies indexed under Health Education.
Browse Health Education studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Mobile-based Educational 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.
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.
Decision Self-Efficacy
Decision self-efficacy is measured using a slightly adapted version of the "Decision Self-Efficacy Scale" developed by A. O'Connor and colleagues at the Ottawa Hospital Research Institute and is available at https://decisionaid.ohri.ca. The scale contains eleven questions about a patient's decision-making process. The scale was adapted to ask questions about the context of prenatal genetic screening and utilizes a three-point response scale. Response choices and corresponding point values are: "A lot confident (4), a little confident (2), and not confident (0)". The values from each response are summed, divided by 11 and multiplied by 100 to give a score range from 0 to 100. Zero indicates no confidence and 100 indicates extreme confidence. A researcher administers the scale over the phone, once to each participant, within 168-hours after the medical appointment where participants are offered prenatal genetic screening. It should take no more than 5-10 minutes to complete.
Time frame: The scale is completed up to 168-hours (7 calendar days) post-prenatal screening visit.
Plan to share: Yes — Data will be shared via the Inter-university Consortium for Political and Social Research. To the extent the context of data collection can be revealed without compromising the privacy and identity of research participants, it will be included in study protocols. Data will be anonymized. Qualitative data such as de-identified and redacted transcripts, coding summaries, and metadata will be shared. Quantitative, including de-identified individual and aggregate survey data (including raw and recoded data) will be shared.
Supporting information: Statistical analysis plan, Informed consent form
Time frame: Approximately six to twelve months after the completion of data analysis. Methods and data collection instruments will be available to the research community before the completion of the study. Published outcomes as well as data deposited in the Inter-university Consortium for Political and Social Research will be available indefinitely.
Access criteria: Access to all deposited materials will be available to researchers registered and verified through the Inter-university Consortium for Political and Social Research (ICPSR). The ICPSR, a digital repository, utilizes a "Reference Model for an Open Archival Information System (OAIS), an International Organization for Standardization (ISO) standard that provides the functional framework for sustaining digital objects in managed repositories." Detailed access criteria can be found here: https://www.icpsr.umich.edu/sites/icpsr/about/policies/access-policy-framework
Started Sep 2026 (actual). Primary completion is estimated for Jun 2028, 21 months after the start.
Of 292 non-industry interventional studies with no phase under Health Education, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 24. This study's planned 21 months is above that.
Counting every sponsor, half of 293 studies reached it within 11 months; a quarter within 3 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
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