Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 8:43 PM
Study NCT ID:
NCT06523569
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '3 months postpartum; 12 months postpartum', 'description': 'All participants will have systolic blood pressure measured at 3 months and 12 months postpartum'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '3 months postpartum; 12 months postpartum', 'description': 'All participants will have weight measured at 3 months and 12 months postpartum'}, {'measure': 'Subclinical cardiovascular dysfunction via echocardiography', 'timeFrame': '3 months postpartum; 12 months postpartum', 'description': 'All participants will have echocardiography performed at 3 months and 12 months postpartum to assess subclinical cardiovascular dysfunction'}, {'measure': 'Study feasibility', 'timeFrame': '12 months postpartum', 'description': 'The investigators will assess study feasibility (% enrolled in digital health intervention) at the end of the study'}, {'measure': 'Participant engagement', 'timeFrame': '12 months postpartum', 'description': 'The investigators will assess participant engagement (% continuing to actively use digital health interventions) at the end of the study'}, {'measure': 'Anti-hypertensive medication use (%)', 'timeFrame': '3 months postpartum; 12 months postpartum', 'description': 'The investigators will assess participant anti-hypertensive medication use (%) at 3 months and 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['digital health', 'echocardiogram', 'blood pressure'], 'conditions': ['Hypertension in Pregnancy', 'Pre-Eclampsia', 'Eclampsia', 'Gestational Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).', 'detailedDescription': 'The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)\n* Live birth at any gestational age\n* Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)\n\nExclusion Criteria:\n\n* HELLP syndrome\n* History of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease)\n* Current Omron remote patient monitoring or Noom user\n* BMI\\<18.5 kg/m2 at enrollment\n* Inadequate gestational weight gain or gestational weight loss"}, 'identificationModule': {'nctId': 'NCT06523569', 'acronym': 'mHEART', 'briefTitle': 'Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy', 'orgStudyIdInfo': {'id': 'STU00219095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care (Control)', 'description': 'Participant will receive usual care.'}, {'type': 'EXPERIMENTAL', 'label': 'Bundled digital health intervention', 'description': 'Participant will be enrolled in a digital blood pressure monitoring program and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care.', 'interventionNames': ['Other: Digital Blood Pressure Monitoring System', 'Other: Mobile health application']}], 'interventions': [{'name': 'Digital Blood Pressure Monitoring System', 'type': 'OTHER', 'description': 'As a part of the bundled digital health intervention, the participant will receive instructions on how to follow a link in their electronic patient portal that will allow direct input of home blood pressure readings for clinical review.', 'armGroupLabels': ['Bundled digital health intervention']}, {'name': 'Mobile health application', 'type': 'OTHER', 'description': 'As a part of the bundled digital health intervention, the participant will be given a lifestyle change mobile health application.', 'armGroupLabels': ['Bundled digital health intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Flores', 'role': 'CONTACT', 'email': 'kathleen.flores@northwestern.edu', 'phone': '312-503-1069'}, {'name': 'Priya Freaney, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwestern University, Dept. of Cardiology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Priya M Freaney, MD', 'role': 'CONTACT', 'email': 'priya.freaney@northwestern.edu', 'phone': '(312) 664-3278'}], 'overallOfficials': [{'name': 'Priya M Freaney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Friends of Prentice', 'class': 'OTHER'}, {'name': 'Senior Faculty Academy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Priya Freaney', 'investigatorAffiliation': 'Northwestern University'}}}}