MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2027-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypertension Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mobile health intervention

Intervention Type OTHER

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

Usual care

Subjects will have their hypertension managed by their respective treating physicians.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile health intervention

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No