Stroke Clinical 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
Verified date | August 2007 |
Source | St George's, University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Interventional |
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
Status | Completed |
Enrollment | 360 |
Est. completion date | April 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | St. Helier NHS Trust | Carshalton | Surrey |
United Kingdom | Mayday University Hospital | Croydon | Surrey |
United Kingdom | St. George's Healthcare Trust | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London | The Stroke Association, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in systolic blood pressure taken by study team at home visit | 12 months | ||
Secondary | Reduction in diastolic blood pressure taken by study team at home visit | 12 months | ||
Secondary | Reduction in SBP and DBP taken by study team at home visit | 6 months | ||
Secondary | Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication | 12 months | ||
Secondary | EQ-5D | 12 months | ||
Secondary | FEAR | 12 months | ||
Secondary | Incremental cost of the intervention to the NHS and cost per QALY | 12 months |
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