Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05830305

MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

Location status: Recruiting

Location contact

Kay Cheong Teo

CONTACT

[email protected]

Kay Cheong Teo

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile health intervention

Other

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

Primary outcomes

  1. Rate of controlled hypertension 12 weeks after ICH

    Time frame: 12 weeks

    Office systolic BP <130 mmHg

Secondary outcomes

  1. Change of BP from recruitment to 12 weeks

    Time frame: 12 weeks

    The difference between BP measurement on recruitment and at 12 weeks

  2. Rate of controlled hypertension 26 weeks after ICH

    Time frame: 26 weeks

    Office systolic BP <130 mmHg

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kay Cheong Teo, MBBS

CONTACT

[email protected]

(852)22553749

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Acronym: MOBILE-ICH

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 26, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.