Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-18 @ 8:41 AM
Study NCT ID:
NCT03111095
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postpartum Hypertension: Remote Patient Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khoppe2@wisc.edu', 'phone': '(206) 371-4014', 'title': 'Kara Hoppe, DO', 'organization': 'University of Wisconsin School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 6 weeks post partum', 'eventGroups': [{'id': 'EG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 0, 'seriousNumAtRisk': 214, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 0, 'seriousNumAtRisk': 214, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aim 1: Number of Participants Enrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 months', 'description': 'A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.'}, {'type': 'PRIMARY', 'title': 'Aim 1: Number of Participants Who Completed the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks', 'description': 'To assess retention, the number of participants who completed the study will be reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.'}, {'type': 'PRIMARY', 'title': 'Aims 2-5: Number of Participants Enrolled in 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nMobile Health: Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': 'Aims 2-5 primary endpoint is enrollment of up to 40 participants at all times (for a total of 42 days) over one year (220 experimental and 220 matched controls for chart review).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Comparison of hypertension-related hospital readmissions between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with hypertensive disorders of pregnancy (HDP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aim 1: 6-week Hospital Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.'}, {'type': 'SECONDARY', 'title': 'Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks', 'description': 'Defined using American College of Obstetricians and Gynecologists (ACOG) criteria blood pressure values of ≥160mmHg (systolic) or ≥110 mmHg (diastolic)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.'}, {'type': 'SECONDARY', 'title': 'Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.'}, {'type': 'SECONDARY', 'title': 'Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks', 'description': 'Defined as participants having blood pressures exceeding the ACOG recommendations for blood pressure treatment (150/100 mmHg).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 10 days of delivery', 'description': 'Comparison of number of participants with at least one blood pressure review within 10 days of delivery between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Comparison of number of participants on antihypertensive treatments between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Maximum Systolic Blood Pressure Intrapartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000', 'lowerLimit': '152', 'upperLimit': '171'}, {'value': '158', 'groupId': 'OG001', 'lowerLimit': '151', 'upperLimit': '167'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission to delivery (up to 96 hours)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '110'}, {'value': '102', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '109'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Admission to delivery (up to 96 hours)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Systolic Blood Pressure at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000', 'lowerLimit': '124', 'upperLimit': '138'}, {'value': '129', 'groupId': 'OG001', 'lowerLimit': '121', 'upperLimit': '136'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 96 hours postpartum', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Diastolic Blood Pressure at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '84'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 96 hours postpartum', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Medication at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'title': 'Any Antihypertensive', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Labetalol', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Nifedipine', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 96 hours postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Postpartum Day of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.35', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.92', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 4.5 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 4 days post-partum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'first prenatal care visit (on average 8-14 weeks of pregnancy, delivery (on average 37-40 weeks of pregnancy)', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants for which both first prenatal care weight and delivery weight were measured.'}, {'type': 'SECONDARY', 'title': 'Self-Administered Questionnaire Satisfaction Survey Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.'}], 'classes': [{'title': "How complicated are mHealth's instructions?", 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'How much mental effort does mHealth require?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'How easily does mHealth fit into your lifestyle?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.65', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'How easy was it to get help?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.33', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'How confident do you feel using the mHealth devices?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.46', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'How hard is the monitor to use?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.49', 'groupId': 'OG000'}]}]}, {'title': 'How organized is the monitor?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.27', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': "How helpful are the monitor's prompts?", 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'How easy is the blood pressure cuff to use?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.44', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'How hard is the weight scale to use?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'How reasonable is the amount of time it takes to record your blood pressure?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.46', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'How reasonable is the amount of time it takes to record your weight?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.47', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'How burdensome is it to record your blood pressure daily?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'How burdensome is it to record your weight daily?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'How secure do you feel submitting your vitals?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.41', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'How much more in control of your own health do you feel?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.91', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'How much more aware of your own health do you feel?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Do you prefer going to clinic/hospital instead of using mHealth for postpartum follow-up?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'How much would you recommend mHealth to others in your situation?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.49', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'How enjoyable are the mHealth devices to use?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.41', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'How satisfied are you with the mHealth devices?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.32', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'To what extent does using the mHealth tech make you feel safer?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.86', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'How often do you feel unsafe while using mHealth?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'How fun is answering questions using the Genesis Touch Monitor?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.24', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Did the Genesis Touch Monitor have all functions you expected?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.02', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Do you like the touch screen technology on the Genesis Touch monitor?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Does using mHealth make you worry more, less or the same?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of mean scores (1-5) are reported here.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 214 participants enrolled in the intervention, 128 participants responded to the 6 week postpartum survey. Not all questions were answered by all survey respondents.'}, {'type': 'SECONDARY', 'title': 'Participant Counts for Relevant SAQ Satisfaction Survey Questions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}], 'classes': [{'title': 'Number of Participants who got help for problems with their devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants for whom it took 1 minute to measure their blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants for whom it took 5 minutes to measure their blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants for whom it took 1 minute to measure their weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants for whom it took 5 minutes to measure their weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participant who had any problems using the Genesis Touch monitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants who had any problems using the blood pressure cuff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants who had any problems using the scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants who had concerns sending their vitals to their health care provider', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants who had enough control over their data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participant who had to go to an emergency room after discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants who had a hospital readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants who went to a different hospital than their delivery hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of questions with participant counts is reported here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 214 participants enrolled in the intervention, 128 participants responded to the 6 week postpartum survey. Not all questions were answered by all survey respondents.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost Effective Analysis on Remote Patient Monitoring for Postpartum Hypertension.', 'timeFrame': 'Up to 12 months', 'description': 'Cost effectiveness modeling will be performed to determine whether it is cost effective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mode of Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'title': 'Vaginal spontaneous', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}, {'title': 'Cesarean', 'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'title': 'Operative vaginal', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery (on average 37-40 weeks of pregnancy)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neonatal Birthweight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '3180', 'groupId': 'OG000', 'lowerLimit': '2660', 'upperLimit': '3540'}, {'value': '3060', 'groupId': 'OG001', 'lowerLimit': '2610', 'upperLimit': '3490'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at time of birth', 'unitOfMeasure': 'grams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neonatal Intensive Care Unit Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at birth', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mobile Health Participants', 'description': 'Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'periods': [{'title': 'Aim 1: Feasibility and Satisfaction', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Eligible Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participants Agreed to be Approached for Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Consented to Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Aims 2-5: Intervention', 'milestones': [{'type': 'STARTED', 'comment': 'Aim 1 participants are included in the 214 participants enrolled and analyzed in Aims 2-5.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'Number Analyzed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between March 2017 and July 2017, 55 women were enrolled into a feasibility study for the intervention (Aim 1). Through June 2018, a total of 428 women were enrolled in this study (214 in the intervention group including those from Aim 1 and 214 in the control group). Participants were recruited from Meriter Hospital in Madison, WI.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mobile Health Participants', 'description': 'Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.\n\nParticipants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '31.5', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '31.5', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-pregnancy BMI', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'BG000', 'lowerLimit': '20.7', 'upperLimit': '42.9'}, {'value': '30.6', 'groupId': 'BG001', 'lowerLimit': '20.2', 'upperLimit': '41.0'}, {'value': '31.2', 'groupId': 'BG002', 'lowerLimit': '20.4', 'upperLimit': '42.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Delivery BMI', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'groupId': 'BG000', 'lowerLimit': '24.2', 'upperLimit': '50.6'}, {'value': '36.6', 'groupId': 'BG001', 'lowerLimit': '22.4', 'upperLimit': '50.8'}, {'value': '37.0', 'groupId': 'BG002', 'lowerLimit': '23.3', 'upperLimit': '50.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Primipara', 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'First time birth', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension Classification', 'classes': [{'title': 'Chronic without Superimposed Preeclampsia', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Chronic with Superimposed Preeclampsia', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Gestational', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}, {'title': 'Preeclampsia', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Other Subtypes of Hypertension of Interest', 'classes': [{'title': 'Mild Preeclampsia', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': 'Severe Preeclampsia', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}, {'title': 'Hemolysis Elevated Liver enzyme Low Platelet (HELLP)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Eclampsia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Married', 'classes': [{'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tobacco Use', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance Status', 'classes': [{'title': 'Private', 'categories': [{'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}, {'title': 'Medicaid', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-gestational Diabetes Mellitus', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age at delivery', 'classes': [{'categories': [{'title': 'Preterm (less than 37 weeks)', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Term (greater than or equal to 37 weeks)', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-11', 'size': 530632, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-29T16:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2017-03-24', 'resultsFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-05', 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost Effective Analysis on Remote Patient Monitoring for Postpartum Hypertension.', 'timeFrame': 'Up to 12 months', 'description': 'Cost effectiveness modeling will be performed to determine whether it is cost effective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy.'}, {'measure': 'Mode of Delivery', 'timeFrame': 'at delivery (on average 37-40 weeks of pregnancy)'}, {'measure': 'Neonatal Birthweight', 'timeFrame': 'at time of birth'}, {'measure': 'Neonatal Intensive Care Unit Admissions', 'timeFrame': 'at birth'}], 'primaryOutcomes': [{'measure': 'Aim 1: Number of Participants Enrolled', 'timeFrame': 'up to 3 months', 'description': 'A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.'}, {'measure': 'Aim 1: Number of Participants Who Completed the Study', 'timeFrame': 'up to 6 weeks', 'description': 'To assess retention, the number of participants who completed the study will be reported.'}, {'measure': 'Aims 2-5: Number of Participants Enrolled in 1 Year', 'timeFrame': 'up to 1 year', 'description': 'Aims 2-5 primary endpoint is enrollment of up to 40 participants at all times (for a total of 42 days) over one year (220 experimental and 220 matched controls for chart review).'}, {'measure': 'Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Comparison of hypertension-related hospital readmissions between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with hypertensive disorders of pregnancy (HDP).'}], 'secondaryOutcomes': [{'measure': 'Aim 1: 6-week Hospital Readmission', 'timeFrame': 'up to 6 weeks'}, {'measure': 'Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge', 'timeFrame': 'up to 6 weeks', 'description': 'Defined using American College of Obstetricians and Gynecologists (ACOG) criteria blood pressure values of ≥160mmHg (systolic) or ≥110 mmHg (diastolic)'}, {'measure': 'Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).'}, {'measure': 'Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge', 'timeFrame': 'up to 6 weeks', 'description': 'Defined as participants having blood pressures exceeding the ACOG recommendations for blood pressure treatment (150/100 mmHg).'}, {'measure': 'Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).'}, {'measure': 'Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery', 'timeFrame': 'up to 10 days of delivery', 'description': 'Comparison of number of participants with at least one blood pressure review within 10 days of delivery between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).'}, {'measure': 'Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'Comparison of number of participants on antihypertensive treatments between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).'}, {'measure': 'Aims 2-5: Maximum Systolic Blood Pressure Intrapartum', 'timeFrame': 'Admission to delivery (up to 96 hours)'}, {'measure': 'Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum', 'timeFrame': 'Admission to delivery (up to 96 hours)'}, {'measure': 'Aims 2-5: Systolic Blood Pressure at Discharge', 'timeFrame': 'Up to 96 hours postpartum'}, {'measure': 'Aims 2-5: Diastolic Blood Pressure at Discharge', 'timeFrame': 'Up to 96 hours postpartum'}, {'measure': 'Aims 2-5: Medication at Discharge', 'timeFrame': 'up to 96 hours postpartum'}, {'measure': 'Aims 2-5: Postpartum Day of Discharge', 'timeFrame': 'up to 4.5 days'}, {'measure': 'Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use', 'timeFrame': 'up to 4 days post-partum'}, {'measure': 'Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery', 'timeFrame': 'first prenatal care visit (on average 8-14 weeks of pregnancy, delivery (on average 37-40 weeks of pregnancy)'}, {'measure': 'Self-Administered Questionnaire Satisfaction Survey Scores', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of mean scores (1-5) are reported here.'}, {'measure': 'Participant Counts for Relevant SAQ Satisfaction Survey Questions', 'timeFrame': 'up to 6 weeks postpartum', 'description': 'In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of questions with participant counts is reported here.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension, Pregnancy-Induced']}, 'referencesModule': {'references': [{'pmid': '32439388', 'type': 'RESULT', 'citation': 'Hoppe KK, Thomas N, Zernick M, Zella JB, Havighurst T, Kim K, Williams M, Niu B, Lohr A, Johnson HM. Telehealth with remote blood pressure monitoring compared with standard care for postpartum hypertension. Am J Obstet Gynecol. 2020 Oct;223(4):585-588. doi: 10.1016/j.ajog.2020.05.027. Epub 2020 May 19. No abstract available.'}, {'pmid': '33607957', 'type': 'RESULT', 'citation': 'Thomas NA, Drewry A, Racine Passmore S, Assad N, Hoppe KK. Patient perceptions, opinions and satisfaction of telehealth with remote blood pressure monitoring postpartum. BMC Pregnancy Childbirth. 2021 Feb 19;21(1):153. doi: 10.1186/s12884-021-03632-9.'}, {'pmid': '30825917', 'type': 'RESULT', 'citation': 'Hoppe KK, Williams M, Thomas N, Zella JB, Drewry A, Kim K, Havighurst T, Johnson HM. Telehealth with remote blood pressure monitoring for postpartum hypertension: A prospective single-cohort feasibility study. Pregnancy Hypertens. 2019 Jan;15:171-176. doi: 10.1016/j.preghy.2018.12.007. Epub 2018 Dec 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if Honeywell Genesis Android Touch Bluetooth System (mobile health) can improve patient satisfaction and quality of care provided to women experiencing complications due to high blood pressure during pregnancy.', 'detailedDescription': 'For six weeks postpartum, patients will use Honeywell Genesis Android Touch Bluetooth System to record and submit their daily blood pressure and weight measurements to a mobile health nurse and research team. Subjects will be provided with the kit (Honeywell tablet, mobile hot spot, blood pressure cuff, and scale) at no cost. Subjects will participate in video telehealth visits at 48 hours and 7 days after discharge to help provide management for hypertension related issues.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensive disorders of pregnancy including gestational, chronic, or preeclampsia diagnosed in the antenatal (primary admission for delivery of the baby (planned or due to hypertension) or postpartum period as determined by systolic blood pressure (SBP) greater than 140 or diastolic blood pressure (DBP) greater than 90 on two occasions 4 hours apart.\n* Gestational age at time of delivery greater than 23 weeks gestation\n* Postpartum with persistent SBP greater than 140 or DBP greater than 90 on two occasions 4 hours apart (to enroll would be prior to discharge from initial postpartum hospital stay).\n* Primary hospital admission for the delivery of the neonate(s).\n\nExclusion Criteria:\n\n* Inability to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT03111095', 'briefTitle': 'Postpartum Hypertension: Remote Patient Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Remote Patient Monitoring - Telehealth for Management of Women With Postpartum Hypertension', 'orgStudyIdInfo': {'id': '2017-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile Health Participants', 'description': 'Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.', 'interventionNames': ['Other: Mobile Health']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.'}], 'interventions': [{'name': 'Mobile Health', 'type': 'OTHER', 'description': 'Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.', 'armGroupLabels': ['Mobile Health Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UnityPoint Health- Meriter Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Kara Hoppe, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Assistant Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}