NCT05830305

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Oct 2023Mar 2027

First Submitted

Initial submission to the registry

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

March 17, 2023

Last Update Submit

January 2, 2026

Conditions

Intracerebral HemorrhageHypertension

Outcome Measures

Primary Outcomes (1)

  • Rate of controlled hypertension 12 weeks after ICH

    Office systolic BP \<130 mmHg

    12 weeks

Secondary Outcomes (3)

  • Change of BP from recruitment to 12 weeks

    12 weeks

  • Rate of controlled hypertension 26 weeks after ICH

    26 weeks

  • Life Simple 7 Score at 12 and 26 weeks

    12 and 26 weeks

Study Arms (2)

Mobile health intervention

ACTIVE COMPARATOR

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

Usual care

NO INTERVENTION

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

Interventions

Mobile health interventionOTHER

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

Mobile health intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary ICH Diagnosis
  • Age ≥ 18 years
  • Discharge Modified Rankin Scale of ≤4

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

  • Biffi A, Teo KC, Castello JP, Abramson JR, Leung IYH, Leung WCY, Wang Y, Kourkoulis C, Myserlis EP, Warren AD, Henry J, Chan KH, Cheung RTF, Ho SL, Anderson CD, Gurol ME, Viswanathan A, Greenberg SM, Lau KK, Rosand J. Impact of Uncontrolled Hypertension at 3 Months After Intracerebral Hemorrhage. J Am Heart Assoc. 2021 Jun;10(11):e020392. doi: 10.1161/JAHA.120.020392. Epub 2021 May 15.

    PMID: 33998241BACKGROUND

  • Teo KC, Keins S, Abramson JR, Leung WCY, Leung IYH, Wong YK, Yeung C, Kourkoulis C, Warren AD, Chan KH, Cheung RTF, Ho SL, Gurol ME, Viswanathan A, Greenberg SM, Anderson CD, Lau KK, Rosand J, Biffi A. Blood Pressure Control Targets and Risk of Cardiovascular and Cerebrovascular Events After Intracerebral Hemorrhage. Stroke. 2023 Jan;54(1):78-86. doi: 10.1161/STROKEAHA.122.039709. Epub 2022 Nov 2.

    PMID: 36321455BACKGROUND

MeSH Terms

Conditions

Cerebral HemorrhageHypertension

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Kay Cheong Teo, MBBS

CONTACT

(852)22553749kcteo@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 26, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

HK(1)