Preeclampsia Educational Program Study (PrEPS)

Not Applicable

Recruiting

• Conditions: Preeclampsia Severe; Preeclampsia; Preeclampsia Mild; Preeclampsia Postpartum
• Interventions: Other: Illustration based application; Other: Text based application

• Registration Number: NCT06373367
• Lead Sponsor: MemorialCare Health System

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-10-01
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Illustration	Illustration based application	This study arm will receive education via an illustration based application
Text	Text based application	This study arm will receive education via text based application

Primary Outcome Measures

Name	Time	Method
Preeclampsia knowledge score - short	Measured at 24 hours postpartum	Short term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment

Secondary Outcome Measures

Name	Time	Method
Preeclampsia knowledge score - long	Measured between 4 - 6 weeks postpartum	Long term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment
GAD-7 score	Measured between 4-6 weeks postpartum	Generalized anxiety score. A score of 0-4 demonstrating none or minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, 15-21 severe anxiety
72 hour BP check	Measured 72 hours after hospital discharge	Adherence to a blood pressure check
Number of participants who attend a postpartum visit	Measured within 6 weeks postpartum	Adherence to one postpartum visit
Daily BP recordings	Measured within 6 weeks postpartum	Percent of daily blood pressure recordings at home
Accessed material	Measured at 6 weeks postpartum	Number of times information accessed postpartum
Unplanned readmission	Measured at 6 weeks postpartum	Number of unplanned readmissions related to preeclampsia

Trial Locations

Locations (1)

MemorialCare Long Beach Medical Center; 🇺🇸 Long Beach, California, United States