MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

Study Overview
=================
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.

Official Title
-----------------
MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

Conditions
-----------------
Intracerebral Hemorrhage, Hypertension

Intervention / Treatment
-----------------
* Other: Mobile health intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mobile health intervention<br>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. | Other: Mobile health intervention<br>* A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented.<br>|
| No Intervention: Usual care<br>Subjects will have their hypertension managed by their respective treating physicians. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of controlled hypertension 12 weeks after ICH | Office BP <130/80 mmHg | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BP from recruitment to 12 weeks | The difference between BP measurement on recruitment and at 12 weeks | 12 weeks | 
| Rate of controlled hypertension 26 weeks after ICH | Office BP <130/80 mmHg | 26 weeks | 
| Morisky Medication Adherence Scale at 12 and 26 weeks | Score ranging from 0-8 points, with the higher scores indicating better drug adherence. | 12 and 26 weeks | 
| Dietary Approaches to Stop Hypertension (DASH) diet Adherence Score at 12 and 26 weeks | Score ranging from 0-10 points, with the higher scores indicating better DASH diet adherence. | 12 and 26 weeks |