Home Blood Pressure Monitoring Trial

Stroke Clinical Trial

Official title:

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

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
• 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

• Ischemic Attack, Transient
• Stroke

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