MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

Hypertension Clinical Trial

— MOBILE-ICH  

Official title:

MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830305
• Other study ID #: UW 22-702
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: The University of Hong Kong
• Contact: Kay Cheong Teo, MBBS
• Phone: (852)22553749
• Email: kcteo[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hypertension
• Intracerebral Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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