Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT06373367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2024-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preeclampsia Educational Program Study (PrEPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preeclampsia knowledge score - short', 'timeFrame': 'Measured at 24 hours postpartum', 'description': 'Short term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment'}], 'secondaryOutcomes': [{'measure': 'Preeclampsia knowledge score - long', 'timeFrame': 'Measured between 4 - 6 weeks postpartum', 'description': 'Long term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment'}, {'measure': 'GAD-7 score', 'timeFrame': 'Measured between 4-6 weeks postpartum', 'description': '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'}, {'measure': '72 hour BP check', 'timeFrame': 'Measured 72 hours after hospital discharge', 'description': 'Adherence to a blood pressure check'}, {'measure': 'Number of participants who attend a postpartum visit', 'timeFrame': 'Measured within 6 weeks postpartum', 'description': 'Adherence to one postpartum visit'}, {'measure': 'Daily BP recordings', 'timeFrame': 'Measured within 6 weeks postpartum', 'description': 'Percent of daily blood pressure recordings at home'}, {'measure': 'Accessed material', 'timeFrame': 'Measured at 6 weeks postpartum', 'description': 'Number of times information accessed postpartum'}, {'measure': 'Unplanned readmission', 'timeFrame': 'Measured at 6 weeks postpartum', 'description': 'Number of unplanned readmissions related to preeclampsia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preeclampsia', 'education'], 'conditions': ['Preeclampsia', 'Preeclampsia Severe', 'Preeclampsia Mild', 'Preeclampsia Postpartum']}, 'referencesModule': {'references': [{'pmid': '10472797', 'type': 'BACKGROUND', 'citation': 'Igdoura SA, Herscovics A, Lal A, Moremen KW, Morales CR, Hermo L. Alpha-mannosidases involved in N-glycan processing show cell specificity and distinct subcompartmentalization within the Golgi apparatus of cells in the testis and epididymis. Eur J Cell Biol. 1999 Jul;78(7):441-52. doi: 10.1016/s0171-9335(99)80071-5.'}, {'pmid': '35916004', 'type': 'BACKGROUND', '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.'}, {'pmid': '34724906', 'type': 'BACKGROUND', '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.'}, {'pmid': '22542120', 'type': 'BACKGROUND', '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.'}, {'pmid': '20860492', 'type': 'BACKGROUND', '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.'}, {'pmid': '12066093', 'type': 'BACKGROUND', '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.'}, {'pmid': '31575778', 'type': 'BACKGROUND', '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.'}, {'pmid': '29133363', 'type': 'BACKGROUND', '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.'}, {'pmid': '32443079', 'type': 'BACKGROUND', 'citation': 'Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe investigators central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only educational material.\n\nSpecific 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.\n\nSpecific 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preeclampsia with or without severe features\n* Able to read and speak English\n* Consistent access to mobile device with QR-reading capability and ability to access mobile-device application.\n* Pre-and postnatal care provided by OB Clinic (resident clinic) or Magella (maternal-fetal medicine)\n\nExclusion Criteria:\n\n* Patient age \\< 18 years old\n* Non-English speaking\n* Current enrollment in another trial targeting postpartum preeclampsia parameters\n* Arm width \\>40cm (XL Cuff)'}, 'identificationModule': {'nctId': 'NCT06373367', 'acronym': 'PrEPS', 'briefTitle': 'Preeclampsia Educational Program Study (PrEPS)', 'organization': {'class': 'OTHER', 'fullName': 'MemorialCare Health System'}, 'officialTitle': 'Preeclampsia Educational Program Study', 'orgStudyIdInfo': {'id': '461-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Illustration', 'description': 'This study arm will receive education via an illustration based application', 'interventionNames': ['Other: Illustration based application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Text', 'description': 'This study arm will receive education via text based application', 'interventionNames': ['Other: Text based application']}], 'interventions': [{'name': 'Illustration based application', 'type': 'OTHER', 'description': 'Illustrations regarding the cause, risks, and warning signs of preeclampsia', 'armGroupLabels': ['Illustration']}, {'name': 'Text based application', 'type': 'OTHER', 'description': 'Standard preeclampsia discharge instructions', 'armGroupLabels': ['Text']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'MemorialCare Long Beach Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}], 'overallOfficials': [{'name': 'Megan Oakes, MD MSCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Magella Medical Group, MemorialCare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MemorialCare Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD MCSI', 'investigatorFullName': 'Megan Oakes', 'investigatorAffiliation': 'MemorialCare Health System'}}}}