MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

Обзор

This randomized controlled trial investigates the efficacy and safety of mobile health intervention in managing hypertension after Intracerebral Hemorrhage (ICH).

Подробное описание

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.

Вмешательства

• Другое Mobile health intervention
  A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented.

Первичные конечные точки

• Rate of controlled hypertension 12 weeks after ICH [Срок оценки: 12 weeks]

Вторичные конечные точки (3)

• Change of BP from recruitment to 12 weeks [Срок оценки: 12 weeks]
• Rate of controlled hypertension 26 weeks after ICH [Срок оценки: 26 weeks]
• Life Simple 7 Score at 12 and 26 weeks [Срок оценки: 12 and 26 weeks]

Критерии участия

Критерии включения

• Primary ICH Diagnosis
• Age ≥ 18 years
• Discharge Modified Rankin Scale of ≤4

Критерии исключения

• Expected life expectancy of <1 year
• Patient or caregiver does not have access to WeRISE App.
• Patient or caregiver does not know how to use WeRISE App .
• Inability to perform home BP monitoring
• Inability to participate in follow-up activity
• 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
• Bleeding tendency (Platelet count < 75 x 10\^9/L; Known coagulation disorder)
• Severe renal impairment (Estimated glomerular filtration rate using CKD-EPI formula <30 ml/min/1.73m2)
• Severe liver impairment (Child-Pugh C cirrhosis)
• Known contraindication or allergy to two or more anti-hypertensive classes

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Queen Mary Hospital — Гонконг

Публикации

• 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 33998241
• 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. PMID 36321455

Идентификаторы

NCT: NCT05830305 · UW 22-702

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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