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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06373367
Other study ID # 461-24
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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