Home Blood Pressure Monitoring Trial
Recruitment status was Recruiting
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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 |
- Reduction in systolic blood pressure taken by study team at home visit [ Time Frame: 12 months ]
- 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 |
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| 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 |
| 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 | |
| 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 May 23, 2013