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Preeclampsia Educational Program Study (PrEPS)

Preeclampsia Educational Program Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06373367
Acronym
PrEPS
Enrollment
36
Registered
2024-04-18
Start date
2024-10-01
Completion date
2026-05-31
Last updated
2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia, Preeclampsia Mild, Preeclampsia Postpartum, Preeclampsia Severe

Keywords

preeclampsia, education

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.

Interventions

OTHERIllustration based application

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

OTHERText based application

Standard preeclampsia discharge instructions

Sponsors

MemorialCare Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Preeclampsia knowledge score - shortMeasured at 24 hours postpartumShort term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment

Secondary

MeasureTime frameDescription
GAD-7 scoreMeasured between 4-6 weeks postpartumGeneralized 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 checkMeasured 72 hours after hospital dischargeAdherence to a blood pressure check
Number of participants who attend a postpartum visitMeasured within 6 weeks postpartumAdherence to one postpartum visit
Preeclampsia knowledge score - longMeasured between 4 - 6 weeks postpartumLong term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment
Accessed materialMeasured at 6 weeks postpartumNumber of times information accessed postpartum
Unplanned readmissionMeasured at 6 weeks postpartumNumber of unplanned readmissions related to preeclampsia
Daily BP recordingsMeasured within 6 weeks postpartumPercent of daily blood pressure recordings at home

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026