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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido, SW17 0RE
- St. George's Healthcare Trust
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Surrey
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Carshalton, Surrey, Reino Unido, SM5 1AA
- St. Helier NHS Trust
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Croydon, Surrey, Reino Unido, CR7 7YE
- Mayday University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Control
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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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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Reduction in systolic blood pressure taken by study team at home visit
Periodo de tiempo: 12 months
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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EQ-5D
Periodo de tiempo: 12 meses
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12 meses
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Reduction in diastolic blood pressure taken by study team at home visit
Periodo de tiempo: 12 months
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12 months
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Reduction in SBP and DBP taken by study team at home visit
Periodo de tiempo: 6 months
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6 months
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Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
Periodo de tiempo: 12 months
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12 months
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FEAR
Periodo de tiempo: 12 months
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12 months
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Incremental cost of the intervention to the NHS and cost per QALY
Periodo de tiempo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sally Kerry, MSc, St George's, University of London
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 07.0002
- TSA 2006/05
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