Home Blood Pressure Monitoring Trial

St George's, University of London

Status and phase: Completed; Phase 3

Conditions: Ischemic Attack, Transient; Stroke

Treatments: Behavioral: Control - usual care (BP monitoring by their practice); Behavioral: Intervention - a validated home BP monitor and support from the specialist nurse

Study type: Interventional

Funder types: Other

Identifiers

NCT00514800

07.0002

TSA 2006/05

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

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

Control

Active Comparator group

Treatment:

Behavioral: Control - usual care (BP monitoring by their practice)