Home Blood Pressure Monitoring Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by St George's, University of London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Stroke Association, United Kingdom
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00514800
First received: August 9, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Stroke
Ischemic Attack, Transient
Behavioral: Intervention - a validated home BP monitor and support from the specialist nurse
Behavioral: Control - usual care (BP monitoring by their practice)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community Based Trial of Home Blood Pressure Monitoring With Nurse Led Support in Patients With Stroke or TIA Recently Discharged From Hospital

Resource links provided by NLM:


Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Reduction in systolic blood pressure taken by study team at home visit [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Reduction in diastolic blood pressure taken by study team at home visit [ Time Frame: 12 months ]
  • Reduction in SBP and DBP taken by study team at home visit [ Time Frame: 6 months ]
  • Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication [ Time Frame: 12 months ]
  • EQ-5D [ Time Frame: 12 months ]
  • FEAR [ Time Frame: 12 months ]
  • Incremental cost of the intervention to the NHS and cost per QALY [ Time Frame: 12 months ]

Estimated Enrollment: 360
Study Start Date: March 2007
Estimated Study Completion Date: April 2009
Arms Assigned Interventions
Experimental: 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.

Behavioral: Intervention - a validated home BP monitor and support from the specialist nurse
Active Comparator: Control 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.


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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514800

Contacts
Contact: Pippa Oakeshott, MD Cantab 020 8725 0153 oakeshot@sgul.ac.uk
Contact: Sally M Kerry, MSc 020 8725 2785 s.kerry@sgul.ac.uk

Locations
United Kingdom
St. Helier NHS Trust Recruiting
Carshalton, Surrey, United Kingdom, SM5 1AA
Contact: Ajay Bhalla, MD    020 8296 2000    Ajay.Bhalla@epsom-sthelier.nhs.uk   
Sub-Investigator: Ajay Bhalla, MD         
Mayday University Hospital Not yet recruiting
Croydon, Surrey, United Kingdom, CR7 7YE
Contact: Valerie Jones, MB BS    020 8401 3672    Valerie.Jones@mayday.nhs.uk   
St. George's Healthcare Trust Recruiting
London, United Kingdom, SW17 0RE
Contact: Hugh Markus, MD    020 8725 2735    h.markus@sgul.ac.uk   
Contact: Pippa Oakeshott, MD    020 8725 0153    oakeshot@sgul.ac.uk   
Principal Investigator: Hugh Markus, DM Oxford         
Sponsors and Collaborators
St George's, University of London
The Stroke Association, United Kingdom
Investigators
Principal Investigator: Sally Kerry, MSc St George's, University of London
  More Information

No publications provided by St George's, University of London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00514800     History of Changes
Other Study ID Numbers: 07.0002, TSA 2006/05
Study First Received: August 9, 2007
Last Updated: August 9, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by St George's, University of London:
Home monitoring
Primary care
Hypertension
TIA

Additional relevant MeSH terms:
Ischemic Attack, Transient
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on April 17, 2014