MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile health intervention.
- Who it may be relevant to
- Registry conditions: Intracerebral Hemorrhage, Hypertension. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This randomized controlled trial investigates the efficacy and safety of mobile health intervention in managing hypertension after Intracerebral Hemorrhage (ICH).
Detailed description
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.
Interventions
- Other Mobile health intervention
A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented.
Primary outcome measures
- Rate of controlled hypertension 12 weeks after ICH [Time frame: 12 weeks]
Secondary outcome measures (3)
- Change of BP from recruitment to 12 weeks [Time frame: 12 weeks]
- Rate of controlled hypertension 26 weeks after ICH [Time frame: 26 weeks]
- Life Simple 7 Score at 12 and 26 weeks [Time frame: 12 and 26 weeks]
Eligibility criteria
Inclusion criteria
- Primary ICH Diagnosis
- Age ≥ 18 years
- Discharge Modified Rankin Scale of ≤4
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Queen Mary Hospital — Hong Kong
Publications
- 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
Identifiers
NCT: NCT05830305 · UW 22-702