Preeclampsia Educational Program Study (PrEPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Different Methods of Patient Education on Preeclampsia

NCT02765906

Preeclampsia Anxiety Hypertension +3 more

COMPLETED NA

Improving Patient Understanding of Preeclampsia

NCT01119183

Preeclampsia

COMPLETED NA

Evaluation of Educational Tools for Pregnant Women

NCT01858324

Preeclampsia

COMPLETED NA

Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound

NCT07167862

Preeclampsia Preeclampsia Postpartum Preeclampsia Severe or Mild

ENROLLING_BY_INVITATION PHASE4

Education and Counseling Program on Pregnant Women With Risk of Preeclampsia

NCT04036786

Pregnancy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Preeclampsia complicates approximately 8% of all pregnancies. While many patients improve following delivery, the disease process remains a leading cause for postpartum morbidity and mortality. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. There is a gap in the literature regarding effective, patient-centered educational tools specifically addressing these elements, especially in the postpartum period.

The investigators propose a pilot, randomized controlled trial of postpartum patients with preeclampsia. The intervention of interest is an illustration-based, educational mobile device application (app) focused on the short- and long-term risks associated with preeclampsia and warning signs and symptoms of worsening disease postpartum. The control for this study will be the same information in a text-only format, also accessed through a mobile device app.

The investigators central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only educational material.

Specific Aim 1: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 24 hours post intervention (short-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at 24 hours post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.

Specific Aim 2: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education \>4 weeks post intervention (long-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at \> 4 weeks post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preeclampsia Preeclampsia Severe Preeclampsia Mild Preeclampsia Postpartum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Illustration

This study arm will receive education via an illustration based application

Group Type EXPERIMENTAL

Illustration based application

Intervention Type OTHER

Illustrations regarding the cause, risks, and warning signs of preeclampsia

Text

This study arm will receive education via text based application

Group Type ACTIVE_COMPARATOR

Text based application

Intervention Type OTHER

Standard preeclampsia discharge instructions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Illustration based application

Illustrations regarding the cause, risks, and warning signs of preeclampsia

Intervention Type OTHER

Text based application

Standard preeclampsia discharge instructions

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Preeclampsia with or without severe features
* Able to read and speak English
* Consistent access to mobile device with QR-reading capability and ability to access mobile-device application.
* Pre-and postnatal care provided by OB Clinic (resident clinic) or Magella (maternal-fetal medicine)

Exclusion Criteria

* Patient age \< 18 years old
* Non-English speaking
* Current enrollment in another trial targeting postpartum preeclampsia parameters
* Arm width \>40cm (XL Cuff)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No