Preeclampsia Educational Program Study (PrEPS)

Preeclampsia Clinical Trial

— PrEPS  

Official title:

Preeclampsia Educational Program Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373367
• Other study ID #: 461-24
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: MemorialCare Health System
• Contact: Alice Sherman-Brown, MD
• Phone: 562-933-2000
• Email: aliceb[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

We 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.

Our 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). We 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). We 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia
• Preeclampsia Mild
• Preeclampsia Postpartum
• Preeclampsia Severe

Intervention

Other:
• Illustration based application
Illustrations regarding the cause, risks, and warning signs of preeclampsia
• Text based application
Standard preeclampsia discharge instructions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MemorialCare Health System

References & Publications (9)

Bruno AM, Allshouse AA, Metz TD, Theilen LH. Trends in Hypertensive Disorders of Pregnancy in the United States From 1989 to 2020. Obstet Gynecol. 2022 Jul 1;140(1):83-86. doi: 10.1097/AOG.0000000000004824. Epub 2022 Jun 7. — View Citation

Chames MC, Livingston JC, Ivester TS, Barton JR, Sibai BM. Late postpartum eclampsia: a preventable disease? Am J Obstet Gynecol. 2002 Jun;186(6):1174-7. doi: 10.1067/mob.2002.123824. — View Citation

Collier AY, Molina RL. Maternal Mortality in the United States: Updates on Trends, Causes, and Solutions. Neoreviews. 2019 Oct;20(10):e561-e574. doi: 10.1542/neo.20-10-e561. — View Citation

Ditisheim A, Wuerzner G, Ponte B, Vial Y, Irion O, Burnier M, Boulvain M, Pechere-Bertschi A. Prevalence of Hypertensive Phenotypes After Preeclampsia: A Prospective Cohort Study. Hypertension. 2018 Jan;71(1):103-109. doi: 10.1161/HYPERTENSIONAHA.117.09799. Epub 2017 Nov 13. — View Citation

Dol J, Hughes B, Bonet M, Dorey R, Dorling J, Grant A, Langlois EV, Monaghan J, Ollivier R, Parker R, Roos N, Scott H, Shin HD, Curran J. Timing of maternal mortality and severe morbidity during the postpartum period: a systematic review. JBI Evid Synth. 2022 Sep 1;20(9):2119-2194. doi: 10.11124/JBIES-20-00578. — View Citation

Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891. — View Citation

Shree R, Hatfield-Timajchy K, Brewer A, Tsigas E, Vidler M. Information needs and experiences from pregnancies complicated by hypertensive disorders: a qualitative analysis of narrative responses. BMC Pregnancy Childbirth. 2021 Nov 2;21(1):743. doi: 10.1186/s12884-021-04219-0. — View Citation

You WB, Wolf M, Bailey SC, Pandit AU, Waite KR, Sobel RM, Grobman W. Factors associated with patient understanding of preeclampsia. Hypertens Pregnancy. 2012;31(3):341-9. doi: 10.3109/10641955.2010.507851. Epub 2010 Sep 22. — View Citation

You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preeclampsia knowledge score - short	Short term preeclampsia knowledge score	Measured at 24 hours postpartum
Secondary	Preeclampsia knowledge score - long	Long term preeclampsia knowledge score	Measured between 4 - 6 weeks postpartum
Secondary	GAD-7 score	Generalized anxiety score	Measured between 4-6 weeks postpartum
Secondary	72 hour BP check	Adherence to a blood pressure check	Measured 72 hours after hospital discharge
Secondary	Postpartum visit	Adherence to one postpartum visit	Measured within 6 weeks postpartum
Secondary	Daily BP recordings	Percent of daily blood pressure recordings at home	Measured within 6 weeks postpartum
Secondary	Accessed material	Number of times information accessed postpartum	Measured at 6 weeks postpartum
Secondary	Unplanned readmission	Number of unplanned readmissions related to preeclampsia	Measured at 6 weeks postpartum