Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT06095960
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2023-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Multi-Component Optional Model (MOM) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of post-partum 6-week comprehensive visit', 'timeFrame': 'Baseline to 6 weeks post-partum', 'description': 'Binary measure (yes/no) of visit completion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maternal Health']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 16-35 weeks gestation\n* Age 18-44 years\n* Ability to speak English, Spanish, or Marshallese\n* Participants may have either a vaginal birth or cesarean section birth\n\nExclusion Criteria:\n\n* Type 1 diabetes on an insulin pump followed closely by endocrinology\n* Uncontrolled Type 2 diabetes\n* End stage renal disease followed closely by nephrology\n* ICU admission at any point during pregnancy or delivery hospitalization\n* Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)\n* Incarceration\n* Mental disability limiting decision-making capacity\n* Uncontrolled chronic hypertension\n* HELLP syndrome during pregnancy\n* Sickle cell disease\n* Maternal heart condition or heart disease\n* Opioid use disorder\n* Lupus\n* Thrombophilia or blood clots\n* Need for blood transfusion during delivery hospitalization\n* Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum'}, 'identificationModule': {'nctId': 'NCT06095960', 'briefTitle': 'Telehealth Multi-Component Optional Model (MOM) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women', 'orgStudyIdInfo': {'id': '276311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth MOM', 'description': 'Telehealth MOM. Each patient will receive ESoC which includes: education on the symptoms to watch for and when to call their healthcare provider, an in-person comprehensive postpartum visit around 6 weeks postpartum, and any additional care deemed necessary by their health care providers. Patients in the Telehealth MOM arm will be also provided with a remote monitoring blood pressure cuff and thermometer and will be instructed to take their blood pressure and temperature twice a day for 14 days after discharge from the hospital. A Registered Nurse will monitor blood pressure and temperature readings over the 14-day period and will contact the patient if the readings are out of range to discuss symptoms and the recommend a course of action. A Registered Nurse will conduct an early postpartum telehealth visit between 10-14 days postpartum.', 'interventionNames': ['Behavioral: Telehealth MOM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Standard of Care', 'description': 'Enhanced standard of care (ESoC). Each patient will be provided education on the symptoms to watch for and when to call their healthcare provider. Patients will be scheduled for a comprehensive postpartum visit around 6 weeks postpartum and any additional care deemed necessary by their health care providers.', 'interventionNames': ['Other: Enhanced Standard of Care']}], 'interventions': [{'name': 'Telehealth MOM', 'type': 'BEHAVIORAL', 'description': 'Patients will receive enhanced standard of care plus remote blood pressure monitoring, remote thermometer, and a 10- to 14-day post-partum telehealth visit.', 'armGroupLabels': ['Telehealth MOM']}, {'name': 'Enhanced Standard of Care', 'type': 'OTHER', 'description': 'Patients will receive enhanced standard of care which includes: education on symptoms and when to call their healthcare provider, comprehensive 6-week post-partum visit, and any healthcare deemed necessary by providers.', 'armGroupLabels': ['Enhanced Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71730', 'city': 'El Dorado', 'state': 'Arkansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenny Halloran', 'role': 'CONTACT', 'email': 'KHalloran@uams.edu'}], 'facility': 'UAMS El Dorado FMC', 'geoPoint': {'lat': 33.20763, 'lon': -92.66627}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenny Halloran', 'role': 'CONTACT', 'email': 'KHalloran@uams.edu'}], 'facility': 'UAMS Fayetteville FMC', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72901', 'city': 'Fort Smith', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenny Halloran', 'role': 'CONTACT', 'email': 'KHalloran@uams.edu'}], 'facility': 'UAMS Fort Smith FMC', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenny Halloran', 'role': 'CONTACT', 'email': 'KHalloran@uams.edu'}], 'facility': 'UAMS Jonesboro FMC', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenny Halloran', 'role': 'CONTACT', 'email': 'KHalloran@uams.edu'}], 'facility': "UAMS Health Women's Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenny Halloran', 'role': 'CONTACT', 'email': 'KHalloran@uams.edu'}], 'facility': 'UAMS Springdale FMC', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}], 'centralContacts': [{'name': 'Brett Rowland, MA', 'role': 'CONTACT', 'email': 'mbrowland@uams.edu', 'phone': '4797138661'}, {'name': 'Kacie Simpson, BS', 'role': 'CONTACT', 'email': 'klsimpson@uams.edu', 'phone': '4797138661'}], 'overallOfficials': [{'name': 'Jennifer Callaghan-Koru, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}, {'name': 'Pearl McElfish, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}