MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

Not Applicable

Recruiting

• Conditions: Intracerebral Hemorrhage; Hypertension
• Interventions: Other: Mobile health intervention

• Registration Number: NCT05830305
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-26
• Study Start: 2023-10-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile health intervention	Mobile health intervention	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.

Primary Outcome Measures

Name	Time	Method
Rate of controlled hypertension 12 weeks after ICH	12 weeks	Office BP \<130/80 mmHg

Secondary Outcome Measures

Name	Time	Method
Change of BP from recruitment to 12 weeks	12 weeks	The difference between BP measurement on recruitment and at 12 weeks
Rate of controlled hypertension 26 weeks after ICH	26 weeks	Office BP \<130/80 mmHg
Life Simple 7 Score at 12 and 26 weeks	12 and 26 weeks	Score ranging from 0-14 points, with the higher scores indicating better lifestyle health

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong