MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors (MOBILE-ICH)

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Hypertension; Intracerebral Hemorrhage

Treatments: Other: Mobile health intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05830305

UW 22-702

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

140 participants in 2 patient groups

Mobile health intervention

Active Comparator group

Description:

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.

Treatment:

Other: Mobile health intervention

Usual care

No Intervention group

Description:

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