Clinical Trials Directory

Trials / Completed

CompletedNCT00514800

Home Blood Pressure Monitoring Trial

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
360 (estimated)
Sponsor
St George's, University of London · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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

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

TypeNameDescription
BEHAVIORALIntervention - a validated home BP monitor and support from the specialist nurse
BEHAVIORALControl - 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.

Timeline

Start date
2007-03-01
Completion
2009-04-01
First posted
2007-08-10
Last updated
2015-06-09

Locations

3 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT00514800. Inclusion in this directory is not an endorsement.