Preeclampsia Educational Program Study (PrEPS)

Not Applicable

Active, not recruiting

• Conditions: Preeclampsia Severe; Preeclampsia; Preeclampsia Mild; Preeclampsia Postpartum

• 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

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-10-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-29
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-06
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_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

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
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
72 hour BP check	Measured 72 hours after hospital discharge	Adherence to a blood pressure check

Trial Locations

Locations (1)

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