Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT05830305
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of controlled hypertension 12 weeks after ICH', 'timeFrame': '12 weeks', 'description': 'Office BP \\<130/80 mmHg'}], 'secondaryOutcomes': [{'measure': 'Change of BP from recruitment to 12 weeks', 'timeFrame': '12 weeks', 'description': 'The difference between BP measurement on recruitment and at 12 weeks'}, {'measure': 'Rate of controlled hypertension 26 weeks after ICH', 'timeFrame': '26 weeks', 'description': 'Office BP \\<130/80 mmHg'}, {'measure': 'Life Simple 7 Score at 12 and 26 weeks', 'timeFrame': '12 and 26 weeks', 'description': 'Score ranging from 0-14 points, with the higher scores indicating better lifestyle health'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracerebral Hemorrhage', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '33998241', 'type': 'BACKGROUND', 'citation': 'Biffi A, Teo KC, Castello JP, Abramson JR, Leung IYH, Leung WCY, Wang Y, Kourkoulis C, Myserlis EP, Warren AD, Henry J, Chan KH, Cheung RTF, Ho SL, Anderson CD, Gurol ME, Viswanathan A, Greenberg SM, Lau KK, Rosand J. Impact of Uncontrolled Hypertension at 3 Months After Intracerebral Hemorrhage. J Am Heart Assoc. 2021 Jun;10(11):e020392. doi: 10.1161/JAHA.120.020392. Epub 2021 May 15.'}, {'pmid': '36321455', 'type': 'BACKGROUND', 'citation': 'Teo KC, Keins S, Abramson JR, Leung WCY, Leung IYH, Wong YK, Yeung C, Kourkoulis C, Warren AD, Chan KH, Cheung RTF, Ho SL, Gurol ME, Viswanathan A, Greenberg SM, Anderson CD, Lau KK, Rosand J, Biffi A. Blood Pressure Control Targets and Risk of Cardiovascular and Cerebrovascular Events After Intracerebral Hemorrhage. Stroke. 2023 Jan;54(1):78-86. doi: 10.1161/STROKEAHA.122.039709. Epub 2022 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigates the efficacy and safety of mobile health intervention in managing hypertension after Intracerebral Hemorrhage (ICH).', 'detailedDescription': '140 ICH survivors will be randomized into mobile health intervention (MOBILE) and the usual care group for hypertension management. All subjects will be educated on the importance of hypertension control after ICH and given lifestyle advice, including the DASH diet. Subjects in the MOBILE group will enter their home blood pressure (BP) measurements into a mobile stroke App (WeRISE) daily, and the study team will regularly review the BP measurements through a backend system. A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented. Subjects in the usual care group will have their hypertension managed by their respective treating physicians. All subjects will be followed up for 26 weeks. The primary and secondary endpoints include the rate of controlled hypertension at 12 and 26 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary ICH Diagnosis\n* Age ≥ 18 years\n* Discharge Modified Rankin Scale of ≤4\n\nExclusion Criteria:\n\n* Expected life expectancy of \\<1 year\n* Patient or caregiver does not have access to WeRISE App.\n* Patient or caregiver does not know how to use WeRISE App .\n* Inability to perform home BP monitoring\n* Inability to participate in follow-up activity\n* Contraindication for intensive and rapid lowering of blood pressure (Known \\>70% cerebral vascular stenosis; History of fall, dizziness or syncope due to hypotension; Any other medical condition that is deemed contraindicated for low blood pressure\n* Bleeding tendency (Platelet count \\< 75 x 10\\^9/L; Known coagulation disorder)\n* Severe renal impairment (Estimated glomerular filtration rate using CKD-EPI formula \\<30 ml/min/1.73m2)\n* Severe liver impairment (Child-Pugh C cirrhosis)\n* Known contraindication or allergy to two or more anti-hypertensive classes'}, 'identificationModule': {'nctId': 'NCT05830305', 'acronym': 'MOBILE-ICH', 'briefTitle': 'MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors', 'orgStudyIdInfo': {'id': 'UW 22-702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mobile health intervention', 'description': 'Subjects will enter their home BP measurements into a mobile stroke App (WeRISE) daily, and the study team will regularly review the BP measurements through a backend system. A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented.', 'interventionNames': ['Other: Mobile health intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Subjects will have their hypertension managed by their respective treating physicians.'}], 'interventions': [{'name': 'Mobile health intervention', 'type': 'OTHER', 'description': 'A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented.', 'armGroupLabels': ['Mobile health intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kay Cheong Teo', 'role': 'CONTACT', 'email': 'kcteo@hku.hk'}, {'name': 'Kay Cheong Teo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Kay Cheong Teo, MBBS', 'role': 'CONTACT', 'email': 'kcteo@hku.hk', 'phone': '(852)22553749'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Teo Kay-Cheong', 'investigatorAffiliation': 'The University of Hong Kong'}}}}