Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-29 @ 11:48 PM
Study NCT ID:
NCT07356518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth and Remote Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of telehealth with remote BP telemonitoring compared to standard care', 'timeFrame': 'Gestational Week 31', 'description': 'willingness to enroll (number of patients enrolled divided by number of patients reached), study completion rate, adherence compared to standard care). Adherence will be defined as taking medication at least ≥80% of the time, recording ≥70% of weekly BP readings in the intervention group only and completing ≥70% of antenatal telehealth/clinic visits.'}, {'measure': 'Safety of telehealth combined with telemonitoring compared to standard care', 'timeFrame': 'Gestational Week 31', 'description': 'The number of adverse events reported (hypotension, syncope or hospitalization/emergency room visit for severe HTN'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction Scores', 'timeFrame': 'Gestational Week 31', 'description': 'at the end of 31 weeks, each participant will complete a patient research satisfaction survey - Strongly disagree 0, disagree 1, neither agree nor disagree 2, agree 3, strongly agree 4'}, {'measure': 'Clinical team member (Medical Assistant, Nursing staff, Medical Provider, Scheduler) satisfaction Scores', 'timeFrame': 'Gestational Week 31', 'description': 'at the end of 31 weeks, each provider of record for each participant will be invited to complete a research satisfaction survey. Nurses, medical assistants, schedulers at the Comprehensive Fetal Care Center who have participated in the telehealth visit with remote monitoring will be invited to complete a research satisfaction survey - Strongly disagree 0, disagree 1, neither agree nor disagree 2, agree 3, strongly agree 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high blood pressure', 'pre-eclampsia', 'hypertension during pregnancy'], 'conditions': ['Hypertension', 'Hypertension in Pregnancy']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to compare the management of chronic hypertension during pregnancy using telehealth visits with blood pressure telemonitoring and health coaching as compared to standard in person clinic visits. The study involves pregnant woman aged 18-45 who are receiving care for chronic hypertension. Participation in this research study will last until their baby is delivered. The number of in-person clinic visits depends on the participant's treatment assignment. Those assigned to telehealth visits will have telehealth visits alternating with clinic visits every two weeks until the end of pregnancy week 31. Those assigned to telehealth visits will also have five sessions with a health coach via telephone or video from the time of enrollment until the end of pregnancy week 36.", 'detailedDescription': 'Hypertension (HTN) in pregnancy requires weekly or bi-weekly in-person visits. Telehealth visits with remote blood pressure (BP) telemonitoring may be an alternative to frequent in-person visits improve adherence. However, the feasibility of this approach in pregnancy is lacking and studies are limited on the use of remote BP telemonitoring in chronic HTN (cHTN) during pregnancy. A digital health platform for BP management in pregnant women at risk for preeclampsia (women with cHTN, prior preeclampsia or kidney disease) found fewer admissions for HTN or suspected preeclampsia in the intervention compared to usual care. There is a critical need to investigate the feasibility (willingness and adherence), and safety of this intervention. Without ascertaining the feasibility of telehealth and remote BP monitoring, it remains a challenge to tackle the no-show rates and suboptimal medication adherence during pregnancy.\n\nObjectives Aim 1: To determine the feasibility of incorporating telehealth clinic visits with remote BP telemonitoring alternating with in-person clinic visits in the management of cHTN in pregnancy in the clinic by evaluating willingness to enroll, completion rate and adherence versus standard care (in-person clinic visits alone). This working hypothesis is that this approach will be as feasible as standard care.\n\nAim 2: To explore safety outcomes of telehealth clinic visits combined with blood pressure remote telemonitoring alternating with in-person clinic visits in the management of chronic hypertension in pregnant patients in the clinic by measuring the incidence of hypotension, syncope or hospitalization/emergency room visits for severe HTN compared to standard care. The working hypothesis is that this approach will be comparable in safety to standard care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* prior diagnosis of Chronic hypertension (cHTN)\n* Pregnant women\n* Known: documented diagnosis or on antihypertensive medication prior to pregnancy\n\nExclusion Criteria:\n\n* Any significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the study\n* Cardiac disorders: cardiomyopathy, angina, Coronary Artery Disease (CAD)\n* Current substance abuse disorder\n* Multifetal pregnancy\n* Participation in another study without prior approval\n* Plan to deliver outside Atrium Health Wake Forest Baptist\n* Prior stroke\n* Severe hypertension\n* Suspected or known fetal major structural/chromosomal abnormality or fetal demise"}, 'identificationModule': {'nctId': 'NCT07356518', 'briefTitle': 'Telehealth and Remote Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Feasibility and Safety of Incorporating Telehealth Visits Combined With Remote Blood Pressure Monitoring in the Management of Chronic Hypertension in Pregnancy', 'orgStudyIdInfo': {'id': 'IRB00142349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth Cycle', 'description': 'Participants in this arm will be provided telehealth visits in addition to the blood pressure telemonitoring.', 'interventionNames': ['Behavioral: Telehealth visits', 'Behavioral: In-person visits']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'In person clinic visits', 'interventionNames': ['Behavioral: In-person visits']}], 'interventions': [{'name': 'Telehealth visits', 'type': 'BEHAVIORAL', 'description': 'remote visits with participants', 'armGroupLabels': ['Telehealth Cycle']}, {'name': 'In-person visits', 'type': 'BEHAVIORAL', 'description': 'standard of care visits with care provider in person', 'armGroupLabels': ['Standard of Care', 'Telehealth Cycle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Ejiro Obioma, MBBS MMCi', 'role': 'CONTACT', 'email': 'Ejiro.Obioma@Advocatehealth.org', 'phone': '704-355-2000'}], 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Ejiro Obioma, MBBS MMCi', 'role': 'CONTACT', 'email': 'Ejiro.Obioma@Advocatehealth.org', 'phone': '704-355-2000'}, {'name': 'Aderonke Adeniyi, MD, MS', 'role': 'CONTACT', 'email': 'aderonke.adeniyi@advocatehealth.org', 'phone': '337 713 2278'}], 'overallOfficials': [{'name': 'Aderonke O Adeniyi, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 12 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underline the results reported in this article, after de-identification (text, tables and appendices)', 'accessCriteria': "Investigators whose proposed use of data has been approved by an independent review committee identified for this purpose.\n\nFor what types of analysis: to achieve aims of the approval proposal and for individual participant data meta-analysis.\n\nBy what mechanism will data become available: Proposals may be submitted up to 36 months. After 36 months the data will be available in our University's data warehouse."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}