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Effects of Comprehensive Care for Knee Osteoarthritis (OA)

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Patient education in self-care of knee OA

Conductual
Quiénes están siendo reclutados

Artritis+2

+ Enfermedades de las Articulaciones

+ Enfermedades del sistema musculoesquelético

A partir de 40 años
+5 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: abril de 1997
Ver detalles del protocolo

Resumen

Patrocinador PrincipalIndiana University
Última actualización: 30 de abril de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de abril de 1997

Fecha en la que se inscribió al primer participante.

Anticipating trends toward generalism in medicine, the rheumatology community has begun to set forth guidelines for managing osteoarthritis (OA). These guidelines emphasize a comprehensive approach toward nondrug treatment (e.g., patient education, exercise, social support) and a conservative approach to drug management to minimize the side effects of nonsteroidal anti-inflammatory drugs (NSAIDs). Unfortunately, few primary care physicians provide conservative, comprehensive care for OA as promoted in the recent rheumatology literature. Also, although researchers have studied individual elements of a comprehensive approach to OA care and largely validated them in isolation, no research support exists to suggest that uniformly adopting OA care guidelines will result in better patient outcomes and/or reduced costs of care. In this project, we will implement, in a controlled fashion, and evaluate a comprehensive plan for treating patients with knee OA by primary care physicians in a managed care environment. Comprehensive care for knee OA will be guided by a procedure designed to introduce and reinforce (a) an array of nondrug, self-care procedures intended to combat joint pain and preserve function and (b) a stepped protocol for drug management of knee pain that minimizes the risk of adverse side effects of NSAIDs. Participants will be 300 patients with a confirmed clinical diagnosis of knee OA who receive their medical care in a large health maintenance organization (HMO) in Indianapolis, Indiana. We will randomly allocate geographically discrete offices of the HMOs to experimental (OA care by algorithm) or control (routine OA care) conditions (150 subjects/group). Patients who enroll in the study at each location will receive care for knee OA for 1 year under the guidelines specified by random assignment. We will measure outcomes at baseline and 3 months, 6 months, and 12 months after enrollment, and outcomes will include joint pain, physical function, drug side effects, quality of life (i.e., general health status), satisfaction with OA care, and direct costs of medical care. We think that comprehensive care, as guided by our algorithms, will result in significant improvement in knee pain, physical function, and patient satisfaction, and lower direct costs compared to care delivered under routine circumstances.

NCT00000404
Patrocinador PrincipalIndiana University
Última actualización: 30 de abril de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 300 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 40 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

ArtritisEnfermedades de las ArticulacionesEnfermedades del sistema musculoesqueléticoEnfermedades reumáticasOsteoartritis

Criterios

2 criterios de inclusión requeridos para participar
All subjects will be able to read and write English, have a telephone, and give informed consent

Study participants must be treated for chronic knee pain by a primary care physician at a participating HMO and satisfy American College of Rheumatology Clinical Criteria for the diagnosis of knee OA

3 criterios de exclusión impiden participar
A known "secondary" cause of OA, including acute or chronic infectious arthritis; crystal-induced arthritis; systemic inflammatory connective tissue disease (e.g., rheumatoid arthritis, systemic lupus erythematosus); osteonecrosis; Paget's disease; or metabolic diseases, such as hemochromatosis, Wilson's disease, or ochronosis

Conditions other than knee OA which limit lower extremity function and mobility and/or would confound the evaluation of knee pain and function (e.g., clinically significant spinal or hip arthritis, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, stroke, etc.)

Significant hematologic, renal, hepatic, or cardiovascular disease (but not including mild/moderate hypertension) or any other serious medical condition that might preclude the subject's ability to participate fully in the project, keep clinic appointments, etc

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Long Hospital, Room 545

Indianapolis, United StatesAbrir Long Hospital, Room 545 en Google Maps
Completado1 Centros de Estudio