Home Blood Pressure Monitoring Trial

NCT ID: NCT00514800

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-04-30

Brief 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

Stroke; Ischemic Attack, Transient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Control

Group Type: ACTIVE_COMPARATOR

Control - usual care (BP monitoring by their practice)

Intervention Type: 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.

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Stroke Association, United Kingdom

OTHER

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: lead

Principal Investigators

Sally Kerry, MSc

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

St. George's Healthcare Trust

London, London, United Kingdom

St. Helier NHS Trust

Carshalton, Surrey, United Kingdom

Mayday University Hospital

Croydon, Surrey, United Kingdom

Countries

United Kingdom

References

Kerry SM, Markus HS, Khong TK, Cloud GC, Tulloch J, Coster D, Ibison J, Oakeshott P. Home blood pressure monitoring with nurse-led telephone support among patients with hypertension and a history of stroke: a community-based randomized controlled trial. CMAJ. 2013 Jan 8;185(1):23-31. doi: 10.1503/cmaj.120832. Epub 2012 Nov 5.

Reference Type: DERIVED

PMID: 23128283 (View on PubMed)

Kerry S, Markus H, Khong T, Doshi R, Conroy R, Oakeshott P. Community based trial of home blood pressure monitoring with nurse-led telephone support in patients with stroke or transient ischaemic attack recently discharged from hospital. Trials. 2008 Mar 19;9:15. doi: 10.1186/1745-6215-9-15.

Reference Type: DERIVED

PMID: 18353175 (View on PubMed)

Other Identifiers

TSA 2006/05

Identifier Type: -

Identifier Source: secondary_id

07.0002

Identifier Type: -

Identifier Source: org_study_id