- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02398812
The Interprofessional Medication Assessment for Older Patients
The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Aging increases the risk of adverse effects and interactions caused by medication. Medication reconciliation and medication review are well-known practices to optimize medicines use. Both interventions usually require a team-based approach to be effective. Medication reconciliation is the process of obtaining and documenting a complete and accurate list of current patient medications and comparing this list with medication orders at each point of care transition to identify and rectify any discrepancies before patient harm occurs. Medication review is the process of evaluating current medication treatment to manage the risk and optimize the outcomes of medication treatment by detecting, solving, and preventing medication-related problems. The present study focuses on medication assessment including both medication reconciliation and review combined to clinical assessment of an individual patient.
According to a systematic review there is a need for research focusing on medication management in community settings and especially to assess the impact of medication assessment on clinical outcomes.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Forssa, Finlandia, FI 30100
- Welfare district of Forssa
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Haapajärvi, Finlandia, FI 85800
- Selänne Basic Health Care District
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Juva, Finlandia, FI-51900
- Juva Health Care
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Lahti, Finlandia, FI-15100
- City of Lahti, home care
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Savonlinna, Finlandia, FI-57100
- Eastern Savo Hospital District
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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:
Home dwelling ≥65 years-old persons registered to public home care services and who
- have had dizziness, orthostatic hypotension or have fallen or
- use at least six medicines
Exclusion Criteria:
Home care is not responsible for patient's medication, for example due to severe chronic illness (for example severe renal insufficiency or cancer with active treatment in secondary or tertiary care).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Active comparator
In addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it
|
Intervention
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Sin intervención: Usual care
Usual care (reference group).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Functional capacity IADL (Instrumental Activities of Daily Living)
Periodo de tiempo: at 6 months from baseline
|
at 6 months from baseline
|
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Functional capacity ADL (Activities of daily living;KATZ)
Periodo de tiempo: at 6 months from baseline
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at 6 months from baseline
|
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Functional capacity TUG (Timed up and go)
Periodo de tiempo: at 6 months from baseline
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at 6 months from baseline
|
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Functional capacity MMSE ( Mini-mental state examination)
Periodo de tiempo: at 6 months from baseline
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at 6 months from baseline
|
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Functional capacity GDS (Geriatric Depression Scale)-15
Periodo de tiempo: at 6 months from baseline
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at 6 months from baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Use of health care services
Periodo de tiempo: at 6 and 12 months from baseline
|
visits to physician, hospital days and nursing care at home
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at 6 and 12 months from baseline
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Need of services delivered to home
Periodo de tiempo: at 6 and 12 months from baseline
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at 6 and 12 months from baseline
|
|
|
Number of medicines
Periodo de tiempo: at 6 and 12 months from baseline
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at 6 and 12 months from baseline
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|
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Quality of medicines
Periodo de tiempo: at 6 and 12 months from baseline
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at 6 and 12 months from baseline
|
|
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Cost of medicines
Periodo de tiempo: at 6 and 12 months from baseline
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at 6 and 12 months from baseline
|
|
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Health related quality of life assessed with EQ-5D
Periodo de tiempo: at 6 and 12 months from baseline
|
at 6 and 12 months from baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Pekka Mäntyselkä, MD, Professor
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- ILMA
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