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

Primary Purpose

Intracerebral Hemorrhage, Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile health intervention
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Mobile health intervention

    Usual care

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Rate of controlled hypertension 12 weeks after ICH
    Office BP <130/80 mmHg

    Secondary Outcome Measures

    Change of BP from recruitment to 12 weeks
    The difference between BP measurement on recruitment and at 12 weeks
    Rate of controlled hypertension 26 weeks after ICH
    Office BP <130/80 mmHg
    Morisky Medication Adherence Scale at 12 and 26 weeks
    Score ranging from 0-8 points, with the higher scores indicating better drug adherence.
    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.

    Full Information

    First Posted
    March 17, 2023
    Last Updated
    April 13, 2023
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05830305
    Brief Title
    MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors
    Acronym
    MOBILE-ICH
    Official Title
    MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracerebral Hemorrhage, Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile health intervention
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Subjects will have their hypertension managed by their respective treating physicians.
    Intervention Type
    Other
    Intervention Name(s)
    Mobile health intervention
    Intervention Description
    A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented.
    Primary Outcome Measure Information:
    Title
    Rate of controlled hypertension 12 weeks after ICH
    Description
    Office BP <130/80 mmHg
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Change of BP from recruitment to 12 weeks
    Description
    The difference between BP measurement on recruitment and at 12 weeks
    Time Frame
    12 weeks
    Title
    Rate of controlled hypertension 26 weeks after ICH
    Description
    Office BP <130/80 mmHg
    Time Frame
    26 weeks
    Title
    Morisky Medication Adherence Scale at 12 and 26 weeks
    Description
    Score ranging from 0-8 points, with the higher scores indicating better drug adherence.
    Time Frame
    12 and 26 weeks
    Title
    Dietary Approaches to Stop Hypertension (DASH) diet Adherence Score at 12 and 26 weeks
    Description
    Score ranging from 0-10 points, with the higher scores indicating better DASH diet adherence.
    Time Frame
    12 and 26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kay Cheong Teo, MBBS
    Phone
    (852)22553749
    Email
    tkc299@hku.hk

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33998241
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36321455
    Citation
    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.
    Results Reference
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    MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

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