Home Blood Pressure Monitoring Trial

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Intervention - a validated home BP monitor and support from the specialist nurse Behavioral
    ARM 1: Kind: Experimental
    Label: Intervention
    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.
  • Control - usual care (BP monitoring by their practice) Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Control

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure 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

Sponsors