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

January 2, 2026 updated by: Teo Kay-Cheong, The University of Hong Kong
This randomized controlled trial investigates the efficacy and safety of mobile health intervention in managing hypertension after Intracerebral Hemorrhage (ICH).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kay Cheong Teo, MBBS
  • Phone Number: (852)22553749
  • Email: kcteo@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
        • Principal Investigator:
          • Kay Cheong Teo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
No Intervention: Usual care
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
Time Frame: 12 weeks
Office systolic BP <130 mmHg
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 22-702

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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