Skip to main content
OpenTrials
Completed

NCT Number: NCT00514800

Home Blood Pressure Monitoring Trial

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypertension Ischemic Attack, Transient Nervous System Diseases Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. George's Healthcare Trust, London, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

Control - usual care (BP monitoring by their practice)

Behavioral

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.

Primary outcomes

  1. Reduction in systolic blood pressure taken by study team at home visit

    Time frame: 12 months

Secondary outcomes

  1. Reduction in diastolic blood pressure taken by study team at home visit

    Time frame: 12 months

  2. Reduction in SBP and DBP taken by study team at home visit

    Time frame: 6 months

  3. Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication

    Time frame: 12 months

  4. EQ-5D

    Time frame: 12 months

  5. FEAR

    Time frame: 12 months

  6. Incremental cost of the intervention to the NHS and cost per QALY

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • The Stroke Association, United Kingdom

Registry information

Official study title

Community Based Trial of Home Blood Pressure Monitoring With Nurse Led Support in Patients With Stroke or TIA Recently Discharged From Hospital

Important dates

Study start
2007
Study completion
2009
First posted
Aug 10, 2007
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.