Home Blood Pressure Monitoring Trial
Community Based Trial of Home Blood Pressure Monitoring With Nurse Led Support in Patients With Stroke or TIA Recently Discharged From Hospital
2 other identifiers
interventional
360
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 stroke
Started Mar 2007
Shorter than P25 for phase_3 stroke
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJune 9, 2015
August 1, 2007
August 9, 2007
June 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in systolic blood pressure taken by study team at home visit
12 months
Secondary Outcomes (6)
Reduction in diastolic blood pressure taken by study team at home visit
12 months
Reduction in SBP and DBP taken by study team at home visit
6 months
Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
12 months
EQ-5D
12 months
FEAR
12 months
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALPatients 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.
Control
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St. George's Healthcare Trust
London, London, SW17 0RE, United Kingdom
St. Helier NHS Trust
Carshalton, Surrey, SM5 1AA, United Kingdom
Mayday University Hospital
Croydon, Surrey, CR7 7YE, United Kingdom
Related Publications (2)
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.
PMID: 23128283DERIVEDKerry 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.
PMID: 18353175DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sally Kerry, MSc
St George's, University of London
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 10, 2007
Study Start
March 1, 2007
Study Completion
April 1, 2009
Last Updated
June 9, 2015
Record last verified: 2007-08