Clinical trial NCT06373367: Preeclampsia Educational Program Study (PrEPS)
Official title: Preeclampsia Educational Program Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preeclampsia
Preeclampsia Severe
Preeclampsia Mild
Preeclampsia Postpartum
Keywords: preeclampsia
education
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Preeclampsia knowledge score - short
timeFrame: Measured at 24 hours postpartum
Secondary outcomes:
measure: Preeclampsia knowledge score - long
timeFrame: Measured between 4 - 6 weeks postpartum
measure: GAD-7 score
timeFrame: Measured between 4-6 weeks postpartum
measure: 72 hour BP check
timeFrame: Measured 72 hours after hospital discharge
measure: Number of participants who attend a postpartum visit
timeFrame: Measured within 6 weeks postpartum
measure: Daily BP recordings
timeFrame: Measured within 6 weeks postpartum
measure: Accessed material
timeFrame: Measured at 6 weeks postpartum
measure: Unplanned readmission
timeFrame: Measured at 6 weeks postpartum
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: MemorialCare Long Beach Medical Center
state: California
Study officials:
affiliation: Magella Medical Group, MemorialCare
name: Megan Oakes, MD MSCI
role: PRINCIPAL_INVESTIGATOR
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