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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00951691
Enhanced Medical Rehabilitation for Disablement
Enhanced Acute Medical Rehabilitation for Disablement
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Disabling medical events are common for elderly people, causing immobilization, requiring extensive rehabilitation, and generating fears of loss of function and need for institutionalization. Existing acute medical rehabilitation settings-skilled nursing facilities (SNFs) and inpatient rehabilitation facilities (IRFs)-often do not adequately meet the needs of depressed elders, resulting in a missed opportunity for effective and functional recovery. This study will test a new program that will enhance acute rehabilitation in SNFs to target mood, motivation, and functional recovery in the 2 to 4 weeks after hospitalization. This program, developed by the research team, increases the intensity and engagement of physical therapy (PT) and occupational therapy (OT).
Participation in this study will last until discharge from the SNF, with follow-up assessments lasting until 3 months after entry. Participants will be randomly assigned to receive either the enhanced acute medical rehabilitation or treatment as usual. Participants receiving the enhanced care will complete up to 3 hours of enhanced PT and OT per day from study entry until discharge, excluding weekends. Participants receiving treatment as usual will receive standard PT and OT. Study assessments will take place at baseline, after 8 and 15 days, and after discharge. Follow-up assessments will occur after 30, 60, and 90 days. Assessments will include questionnaires and interviews measuring positive and negative affect, and functional impairment and disability.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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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:
- Admitted to Barnes Extended Care nursing home
- Acute disablement
- (criterion dropped) Clinically depressive symptoms, including a score of 15 or greater on the Hamilton Depression Rating Scale (HAM-D) and depressed mood or anhedonia present more days than not since the fracture
Exclusion Criteria:
- Unable to provide informed consent due to dementia and severe persistent delirium
- Inability to cooperate with the protocol
- Cardiac or other medical instability that would preclude carrying out high intensity exercises
- Language, visual, or hearing barriers to participation
- Presence of pelvic fractures that do not involve the proximal femur
- Presence of metastatic cancer, including cancer that causes a pathological fracture
- Bilateral acute hip fractures
- Lifetime psychosis or mania
- Alcohol or substance dependence within 6 months, or current (prior to hip fracture) alcohol or substance abuse
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Tratamiento como de costumbre
Los participantes recibirán el tratamiento habitual.
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Standard treatment with physical and occupational therapies
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Experimental: Enhanced acute medical rehabilitation
Participants will receive enhanced acute medical rehabilitation.
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Daily up to 3-hour sessions of enhanced physical and occupational therapies (see Lenze et al, "Enhanced Medical Rehabilitation Increases Therapy Intensity and Engagement and Improves Functional Outcomes in Postacute Rehabilitation of Older Adults: A Randomized-Controlled Trial."
J American Medical Director's Association, 2012 for details and outcome data.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
functional recovery
Periodo de tiempo: baseline, end of nursing home admission
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Barthel Index.
Secondary Measures are gait speed and 6 minute walk.
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baseline, end of nursing home admission
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
positive and negative affect
Periodo de tiempo: Measured from baseline to SNF discharge
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13 items assessing positive and negative affect
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Measured from baseline to SNF discharge
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric J Lenze, MD, Washington University School of Medicine
Publicaciones y enlaces útiles
Publicaciones Generales
- Hildebrand MW, Host HH, Binder EF, Carpenter B, Freedland KE, Morrow-Howell N, Baum CM, Dore P, Lenze EJ. Measuring treatment fidelity in a rehabilitation intervention study. Am J Phys Med Rehabil. 2012 Aug;91(8):715-24. doi: 10.1097/PHM.0b013e31824ad462.
- Lenze EJ, Host HH, Hildebrand MW, Morrow-Howell N, Carpenter B, Freedland KE, Baum CA, Dixon D, Dore P, Wendleton L, Binder EF. Enhanced medical rehabilitation increases therapy intensity and engagement and improves functional outcomes in postacute rehabilitation of older adults: a randomized-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):708-12. doi: 10.1016/j.jamda.2012.06.014. Epub 2012 Aug 3.
- Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
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
- R34MH083868 (Subvención/contrato del NIH de EE. UU.)
- DATR A4-GPS
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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