- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01769742
Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients
Use of Early Mobilisation to Reduce Incidence of Hospital Acquired Pneumonia in Medical Inpatients
Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In surgical specialities and critical care early physiotherapy is a recognised way of preventing such infections, and reducing length of hospital stay (LOS), however prevention of this problem is less well studied in medical inpatients.
The investigators propose a pilot study to assess the impact of introducing an early mobilisation strategy to general medical and respiratory wards at an acute Trust in the United Kingdom (UK). The investigators will recruit all new admissions to each of 2 respiratory and 2 elderly care wards - 1 of each ward type will be allocated to receive extra physiotherapy input targeting new admissions for early mobilisation. Patients' usual mobility, current mobility and actual activity levels will be studied by accelerometer and simple patient questionnaire in the first 48 hours of admission, and compared between groups. Incidence of HAP and total LOS will be recorded and compared between groups.
The investigators hypotheses are that the physiotherapy intervention will increase activity levels, reduce incidence of HAP and reduce LOS. The latter may result in cost savings to the National Health Service (NHS), which the investigators will model using local tariff data.
The investigators plan to use our data to power a larger randomised controlled study, or if the intervention is a marked success, such that a control group would be unethical, then a wider service development and evaluation programme.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
West Midlands
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Birmingham, West Midlands, Reino Unido, B9 5SS
- Heart of England NHS Trust
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Any medical inpatient
Exclusion Criteria:
- Nil for main study
- Immobile patients and those unable to consent will be excluded from the sub-study using activity reporting and monitoring by Actigraph
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Early mobility bundle
Delivery of early targeted physiotherapy to patients on the interventional wards; to comprise assessment and communication of mobility to ward staff and patient, provision of mobility aids, guidance and encouragement to patient and staff to allow patient to dress and mobilise independently if clinically safe to do so
|
|
|
Sin intervención: Usual care
Usual physiotherapy service only
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of hospital acquired pneumonia
Periodo de tiempo: Duration of hospital stay (up to 12 days)
|
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care.
This is the time period in which incidence of hospital acquired pneumonia will be measured, and expressed as incidence/week of stay.
Patients whose length of stay is lower or higher than average will not be excluded.
|
Duration of hospital stay (up to 12 days)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Length of hospital stay in days
Periodo de tiempo: Duration of hospital stay (up to 12 days)
|
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care.
This is the time period in which incidence of hospital acquired pneumonia will be measured.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
|
Incidence of falls
Periodo de tiempo: Duration of hospital stay (up to 12 days)
|
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care.
This is the time period in which incidence of hospital acquired pneumonia will be measured.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
|
Incidence of pressure area problems
Periodo de tiempo: Duration of hospital stay (up to 12 days)
|
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care.
This is the time period in which incidence of hospital acquired pneumonia will be measured.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Activity levels as reported by patient
Periodo de tiempo: Days 1 and 2 of admission to ward
|
Days 1 and 2 of admission to ward
|
|
Activity levels as measured by Actigraph
Periodo de tiempo: Day 1 and 2 of admission to ward
|
Day 1 and 2 of admission to ward
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alice Turner, University of Birmingham
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
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
- RG-12-237
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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