Educational Program for Preeclampsia

(PrEPS Trial)

Overseen By Alice Sherman-Brown, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: MemorialCare Health System

Disqualifiers: Age < 18, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to assist people with preeclampsia, a complication affecting about 8% of pregnancies. The goal is to determine if this illustration-based app improves understanding of the condition more effectively than traditional text-based instructions. Participants will use either the illustration-based or text-based application to learn about the risks, symptoms, and warning signs of preeclampsia. The trial suits those who have preeclampsia, can read and speak English, and have regular access to a mobile device. As an unphased trial, it offers a unique opportunity to contribute to innovative educational tools that could enhance patient understanding and management of preeclampsia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational program is safe for patients?

Research has shown that educational tools, such as apps, are generally safe. No evidence suggests that using an app with illustrations to learn about preeclampsia causes harm.

Both the illustration-based app and the text-based app in this trial aim to provide information. They do not involve drugs or medical procedures, which typically carry a higher risk of side effects. Since this trial focuses on education, it lacks the physical safety risks often associated with drug trials.

In summary, using an app to learn about preeclampsia is considered safe. The goal is to enhance understanding, which can aid in early risk detection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this educational program for preeclampsia because it aims to enhance patient understanding through innovative delivery methods. Unlike traditional approaches that often rely on in-person counseling or printed materials, this program uses digital applications—one based on illustrations and another on text—making it more accessible and engaging. The illustration-based application is particularly unique, as it leverages visual learning to convey complex medical information, which could be more effective for certain learners. By utilizing these modern digital tools, the program has the potential to improve patient awareness and management of preeclampsia, leading to better health outcomes.

What evidence suggests that this trial's educational programs could be effective for preeclampsia?

This trial will compare two educational approaches for preeclampsia: an illustration-based application and a text-based application. Studies have shown that mobile apps can significantly enhance pregnant women's knowledge about preeclampsia, including understanding the condition, recognizing risk factors, and identifying warning signs. Research also indicates that these educational tools improve women's understanding of heart health risks related to preeclampsia. By employing engaging and interactive formats, such as illustrations, these programs aim to provide women with crucial health information. Early findings suggest that this approach can lead to better health outcomes by promoting informed decision-making and self-care during pregnancy. ^{1 6 7 8 9}

Who Is on the Research Team?

Megan Oakes, MD MSCI

Principal Investigator

Magella Medical Group, MemorialCare

Are You a Good Fit for This Trial?

This trial is for pregnant individuals diagnosed with preeclampsia who can read and speak English, receive care from specific clinics, and have consistent access to a mobile device that can scan QR codes and run applications.

Inclusion Criteria

I have been diagnosed with preeclampsia.

I have a smartphone or tablet that can scan QR codes and use apps.

My prenatal and postnatal care is managed by an OB clinic or a maternal-fetal medicine specialist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants receive education via either an illustration-based app or a text-based app

24 hours

1 visit (in-person)

Short-term Follow-up

Participants' preeclampsia knowledge scores are assessed 24 hours post-intervention

24 hours

Long-term Follow-up

Participants' preeclampsia knowledge scores and other secondary outcomes are assessed between 4 to 6 weeks postpartum

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Illustration based application
• Text based application

Trial Overview The study compares two methods of patient education on preeclampsia: one using an illustration-based app and the other using standard discharge instructions. The goal is to see which method improves patient knowledge more effectively.

How Is the Trial Designed?

Group I: Illustration Experimental Treatment 1 Intervention

This study arm will receive education via an illustration based application

Group II: Text Active Control 1 Intervention

This study arm will receive education via text based application

Who Is Running the Clinical Trial?

MemorialCare Health System

Lead Sponsor

Trials

21

Recruited

2,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06373367

Preeclampsia Educational Program Study (PrEPS) The investigators central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11431801/

Effect of Comprehensive Educational Program on ... Purpose: To evaluate the effect of a comprehensive educational program on preeclamptic women's knowledge, risk perception of cardiovascular ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505618312346

Improving the knowledge of pregnant women using a pre- ... The results showed that the use of a mobile-based educational application improves the knowledge of pregnant women about pre-eclampsia.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9252511/

Impact of Educational Interventions on Knowledge About ... The goal of this systematic review was to investigate the effect of interventional educations on the knowledge of pregnant women about HDP.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/22799036221104161

The effectiveness of psycho-educational counseling in ... This systematic review concludes that improving prenatal empowerment and self-care enable mothers to experience fewer complications in this period of their ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10945012/

AI-based preeclampsia detection and prediction with ... In this study, we developed artificial intelligence models to detect and predict preeclampsia from electrocardiograms (ECGs) in point-of-care settings.

7. saferbirth.org saferbirth.org/aim-data/overview/

Data for Maternal Morbidity Prevention | AIM AIM develops project measurement strategies for its patient safety bundles to support adoption and evaluation of rapid cycle quality improvement activities.

8. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.124.321673

Artificial Intelligence and Machine Learning in Preeclampsia This brief review discusses the recent applications of artificial intelligence and machine learning in preeclampsia management and research.

9. nature.com nature.com/articles/s41746-022-00612-x

Improving preeclampsia risk prediction by modeling ... The resulting models predicted preeclampsia with high accuracy across the different pregnancy periods, with areas under the receiver operating ...