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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00514800
Other study ID # 07.0002
Secondary ID TSA 2006/05
Status Completed
Phase Phase 3
First received August 9, 2007
Last updated June 5, 2015
Start date March 2007
Est. completion date April 2009

Study information

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

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention - a validated home BP monitor and support from the specialist nurse

Control - usual care (BP monitoring by their practice)
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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
St George's, University of London The Stroke Association, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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