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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00514800
Enrollment
360
Registered
2007-08-10
Start date
2007-03-31
Completion date
2009-04-30
Last updated
2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Attack, Transient, Stroke

Keywords

Home monitoring, Primary care, Hypertension, TIA

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.

Interventions

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.

Sponsors

The Stroke Association, United Kingdom
CollaboratorOTHER
St George's, University of London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Reduction in systolic blood pressure taken by study team at home visit12 months

Secondary

MeasureTime frame
Reduction in SBP and DBP taken by study team at home visit6 months
Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication12 months
Reduction in diastolic blood pressure taken by study team at home visit12 months
FEAR12 months
Incremental cost of the intervention to the NHS and cost per QALY12 months
EQ-5D12 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026