Home Blood Pressure Monitoring Trial
Primary Purpose
Stroke, Ischemic Attack, Transient
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention - a validated home BP monitor and support from the specialist nurse
Control - usual care (BP monitoring by their practice)
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring Home monitoring, Primary care, Hypertension, TIA
Eligibility Criteria
Inclusion Criteria:
- Stroke or TIA in last 9 months
- Blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication
Exclusion Criteria:
- Severe illness likely to dominate pattern of care
- Already using home blood pressure monitor
- Non-English speaking
- Severe cognitive impairment (AMTS<7)
- Known secondary hypertension
Sites / Locations
- St. Helier NHS Trust
- Mayday University Hospital
- St. George's Healthcare Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Patients will be given a home blood pressure monitor and taught how to use it and how to respond to the readings using a standardised protocol and blood pressure targets. The study nurse will follow up patients at home after a month with additional telephone support according to a defined protocol. Patients will consult their own GP for medication changes when above target. GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings.
Outcomes
Primary Outcome Measures
Reduction in systolic blood pressure taken by study team at home visit
Secondary Outcome Measures
Reduction in diastolic blood pressure taken by study team at home visit
Reduction in SBP and DBP taken by study team at home visit
Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
EQ-5D
FEAR
Incremental cost of the intervention to the NHS and cost per QALY
Full Information
NCT ID
NCT00514800
First Posted
August 9, 2007
Last Updated
June 5, 2015
Sponsor
St George's, University of London
Collaborators
The Stroke Association, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT00514800
Brief Title
Home Blood Pressure Monitoring Trial
Official Title
Community Based Trial of Home Blood Pressure Monitoring With Nurse Led Support in Patients With Stroke or TIA Recently Discharged From Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St George's, University of London
Collaborators
The Stroke Association, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Design: Community based randomised trial with follow up after 12 months Participants: 360 patients admitted with stroke or TIA within the past 9 months will be recruited from the wards or outpatients and randomly allocated into two groups. All patients will be visited by the specialist nurse at home at baseline when she will measure their BP and administer a questionnaire. The questionnaire and BP will be repeated at 12 months follow-up by another researcher blind as to whether the patient is in intervention or control group.
Intervention: Intervention patients will be given a validated home BP monitor and support from the specialist nurse. Control patients will continue with usual care (BP monitoring by their practice).
Main outcome measures in both groups after 12months: 1.Change in systolic BP 2.Cost effectiveness: Incremental cost of the intervention to the NHS and incremental cost per quality adjusted life year gained.
Study hypothesis. Home blood pressure monitoring with nurse support wil lead to lower blood pressure after 12 months compared with usual GP care
Detailed Description
High blood pressure in patients with stroke increases the risk of recurrence but management in the community is often inadequate. Home blood pressure monitoring may increase patients' involvement in their care, increase compliance, and reduce the need for patients to attend their GP if blood pressure is adequately controlled. However the value of home monitoring to improve BP control is unclear and there is now a window of opportunity for evaluation before their use becomes widespread in the UK. Furthermore its use in stroke patients presents unique challenges relating to the consequent neurological disability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Attack, Transient
Keywords
Home monitoring, Primary care, Hypertension, TIA
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients will be given a home blood pressure monitor and taught how to use it and how to respond to the readings using a standardised protocol and blood pressure targets. The study nurse will follow up patients at home after a month with additional telephone support according to a defined protocol. Patients will consult their own GP for medication changes when above target.
GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings.
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Intervention - a validated home BP monitor and support from the specialist nurse
Intervention Type
Behavioral
Intervention Name(s)
Control - usual care (BP monitoring by their practice)
Intervention Description
Patients will not receive a blood pressure monitor and will continue with usual GP care for hypertension management.
GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings.
Primary Outcome Measure Information:
Title
Reduction in systolic blood pressure taken by study team at home visit
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Reduction in diastolic blood pressure taken by study team at home visit
Time Frame
12 months
Title
Reduction in SBP and DBP taken by study team at home visit
Time Frame
6 months
Title
Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
Time Frame
12 months
Title
EQ-5D
Time Frame
12 months
Title
FEAR
Time Frame
12 months
Title
Incremental cost of the intervention to the NHS and cost per QALY
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stroke or TIA in last 9 months
Blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication
Exclusion Criteria:
Severe illness likely to dominate pattern of care
Already using home blood pressure monitor
Non-English speaking
Severe cognitive impairment (AMTS<7)
Known secondary hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally Kerry, MSc
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Helier NHS Trust
City
Carshalton
State/Province
Surrey
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Mayday University Hospital
City
Croydon
State/Province
Surrey
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
St. George's Healthcare Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23128283
Citation
Kerry SM, Markus HS, Khong TK, Cloud GC, Tulloch J, Coster D, Ibison J, Oakeshott P. Home blood pressure monitoring with nurse-led telephone support among patients with hypertension and a history of stroke: a community-based randomized controlled trial. CMAJ. 2013 Jan 8;185(1):23-31. doi: 10.1503/cmaj.120832. Epub 2012 Nov 5.
Results Reference
derived
PubMed Identifier
18353175
Citation
Kerry S, Markus H, Khong T, Doshi R, Conroy R, Oakeshott P. Community based trial of home blood pressure monitoring with nurse-led telephone support in patients with stroke or transient ischaemic attack recently discharged from hospital. Trials. 2008 Mar 19;9:15. doi: 10.1186/1745-6215-9-15.
Results Reference
derived
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Home Blood Pressure Monitoring Trial
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