1400 Participants NeededMy employer runs this trial

Mobile-Based Education for Pregnancy

Recruiting at 2 trial locations
HC
SR
Overseen BySabina Rubeck, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Case Western Reserve University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile-based educational intervention that provides pregnant participants with important information about prenatal genetic screening. The goal is to determine if users of the tool feel more confident in making screening decisions compared to non-users. Participants will either use the tool on their phone before their doctor's visit or receive standard care without it. Eligible participants should be pregnant, have not yet been offered screening for this pregnancy, and receive care at specific hospitals.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance prenatal care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile-based intervention for decision-making about prenatal genetic screening, so it's unlikely to require changes to your medication.

What prior data suggests that this mobile-based educational intervention is safe for pregnant participants?

Research has shown that mobile health tools, like the one in this trial, are generally safe. Studies on mobile apps for pregnant women found them to be well-tolerated, with no major problems reported. This suggests that using a mobile app to assist with prenatal genetic screening decisions is likely safe.

These tools provide information and support to help users make informed choices. So far, users have not reported any significant negative effects. The main goal is to offer clear and helpful information to pregnant participants without causing harm.

In this trial, the tool is an educational app on a mobile phone that aids decision-making about prenatal genetic screening. Since it involves reading information and is non-invasive, it is unlikely to pose any safety risks. Participants can feel confident that the app is designed to support them safely.12345

Why are researchers excited about this trial?

Researchers are excited about the Mobile-based Educational Intervention for pregnancy because it offers a fresh approach to prenatal genetic screening education. Unlike the standard of care, which involves in-person counseling from clinicians, this intervention delivers concise, culturally appropriate information directly to participants' mobile devices. This method not only makes access to important information more convenient but also empowers expectant mothers by boosting their decisional self-efficacy, helping them make informed choices confidently.

What evidence suggests that this mobile-based educational intervention is effective for prenatal genetic screening?

This trial will compare a mobile-based educational intervention with standard care for prenatal genetic screening. Studies have shown that mobile-based educational programs assist with decision-making during pregnancy. For example, one study found that mobile health tools increased pregnant women's knowledge and confidence about prenatal testing. Another study indicated that these tools can reduce anxiety by providing clear information. Mobile-based programs may also improve pregnancy outcomes by helping parents make informed choices. Research suggests that using technology for prenatal education effectively enhances understanding and decision-making skills.14567

Who Is on the Research Team?

MM

Marsha Michie, PhD

Principal Investigator

Case Western Reserve University

MA

Megan Allyse, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for pregnant people who are up to 24 weeks along, at least 18 years old, getting care at certain hospitals, can read and speak English or Spanish, and have not yet been offered prenatal genetic screening during this pregnancy.

Inclusion Criteria

* 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.
I am 24 weeks pregnant or less.
I am 18 years old or older.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Intervention

Participants use a mobile-based educational tool about prenatal genetic screening before their clinical visit

1 day
1 visit (virtual)

Post-Visit Assessment

Participants complete a structured quantitative telephone interview to assess their experience and measure decisional self-efficacy

7 days
1 visit (phone)

Follow-up

A select subset of participants will participate in an additional qualitative telephone interview to assess the efficacy and usability of the intervention

1-2 weeks
1 visit (phone)

What Are the Treatments Tested in This Trial?

Interventions

  • Mobile-based Educational Intervention

Trial Overview

The study tests if a short set of educational cards on a mobile phone helps pregnant participants feel more confident about making decisions on prenatal genetic screening. Some will use the intervention before their first doctor visit; others will get usual care only.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mobile-based Educational InterventionExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials
273
Recruited
299,000+

Citations

The influence of mobile health intervention on the rate ... - PMC

The study aims to evaluate the impact of a mobile health intervention based on the Behavior Change Wheel theory and Family Health Theory on prenatal diagnostic ...

Prenatal screening educational interventions for U.S. pregnant ...

The purpose of this scoping review was to highlight major outcomes resulting from prenatal screening educational interventions in the U.S., ...

Study Details | NCT07077707 | Prenatal Genetics Chatbot ...

The expected outcome of this study is high-quality evidence on the ability of an educational chatbot to equitably increase patient knowledge and uptake of ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38117555/

Mobile Prenatal Education and Its Impact on Reducing ...

This study aims to develop and evaluate the effectiveness of a mobile-based prenatal education program in improving pregnancy outcomes.

The influence of mobile health intervention on the rate ...

Primary outcomes include prenatal diagnostic needs and pregnancy outcomes, while secondary outcomes include health knowledge, anxiety and ...

Impact of a Mobile App on Pregnant Women's Prenatal ...

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

Mobile-Based Education for Pregnancy · Info for Participants

This clinical trial is about prenatal genetic screening. It will test an intervention to help people make decisions about screening.