Clinical trial NCT00514800: Home Blood Pressure Monitoring 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Ischemic Attack, Transient
Keywords: Home monitoring
Primary care
Hypertension
TIA
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: The Stroke Association, United Kingdom
First posted: 2007-08-10
Enrollment: 360
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Reduction in systolic blood pressure taken by study team at home visit
timeFrame: 12 months
Secondary outcomes:
measure: Reduction in diastolic blood pressure taken by study team at home visit
timeFrame: 12 months
measure: Reduction in SBP and DBP taken by study team at home visit
timeFrame: 6 months
measure: Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
timeFrame: 12 months
measure: EQ-5D
timeFrame: 12 months
measure: FEAR
timeFrame: 12 months
measure: Incremental cost of the intervention to the NHS and cost per QALY
timeFrame: 12 months
Other outcomes:
Locations:
city: Carshalton
country: United Kingdom
facility: St. Helier NHS Trust
state: Surrey
city: Croydon
country: United Kingdom
facility: Mayday University Hospital
state: Surrey
city: London
country: United Kingdom
facility: St. George's Healthcare Trust
Study officials:
affiliation: St George's, University of London
name: Sally Kerry, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.