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
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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London, Det Forenede Kongerige, SW17 0RE
- St. George's Healthcare Trust
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Surrey
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Carshalton, Surrey, Det Forenede Kongerige, SM5 1AA
- St. Helier NHS Trust
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Croydon, Surrey, Det Forenede Kongerige, CR7 7YE
- Mayday University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Styring
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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. |
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Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Reduction in systolic blood pressure taken by study team at home visit
Tidsramme: 12 months
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12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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EQ-5D
Tidsramme: 12 måneder
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12 måneder
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Reduction in diastolic blood pressure taken by study team at home visit
Tidsramme: 12 months
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12 months
|
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Reduction in SBP and DBP taken by study team at home visit
Tidsramme: 6 months
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6 months
|
|
Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
Tidsramme: 12 months
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12 months
|
|
FEAR
Tidsramme: 12 months
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12 months
|
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Incremental cost of the intervention to the NHS and cost per QALY
Tidsramme: 12 months
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12 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sally Kerry, MSc, St George's, University of London
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07.0002
- TSA 2006/05
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