- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00447655
Improving Outcomes Following Limb Loss: PALS Plus (PALS-PLUS)
12 de diciembre de 2017 actualizado por: Johns Hopkins University
Limb loss can result from a variety of etiologies including diabetes, trauma and cancer.
Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life.
Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and established the effectiveness of a self-management program (PALS) to improve health and outcomes following limb loss.
Literature suggests that the access to, and effectiveness and utilization of, this class of interventions may be enhanced by the concerted use of early intervention, peer mentorship, motivational interviewing and provider training.
Objectives: Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention- PALS Plus.
The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS Plus intervention in maximizing utilization of self-management interventions for persons with limb loss.
A cohort of 200 patients will be enrolled prior to implementation of the intervention and will serve as the control group.
Subsequently, a second cohort of 200 patients will be enrolled and receive the PALS Plus intervention and will serve as the intervention group.
Assessment will be at baseline, treatment completion and six month follow-up.
Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood.
Secondary outcome measures are: function, participation and bothersomeness of limitations.
The investigation will also provide unique and valuable information regarding patients' acceptance and use of peer visitation and self-management following limb loss.
Relevance: By establishing the utility and effectiveness of the enhanced self-management intervention, there is the potential to improve the health, activity, participation and quality of life for individuals with disabilities.
The intervention addresses the areas of activity and participation in such a way that it can be implemented in local health care facilities working in combination with a national consumer based organization - the Amputee Coalition of America.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Limb loss can result from a variety of etiologies including diabetes, trauma and cancer.
Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life.
Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and established the effectiveness of a self-management program (PALS) to improve health and outcomes following limb loss.
Literature suggests that the access to, and effectiveness and utilization of, this class of interventions may be enhanced by the concerted use of early intervention, peer mentorship, motivational interviewing and provider training.
Objectives: Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention- PALS Plus.
The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS Plus intervention in maximizing utilization of self-management interventions for persons with limb loss.
Study Design and Participants: The prospective clinical trial will use a two group, lagged-control design to evaluate the intervention at five health care facilities.
A cohort of 200 patients will be enrolled prior to implementation of the intervention and will serve as the control group.
Subsequently, a second cohort of 200 patients will be enrolled and receive the PALS Plus intervention and will serve as the intervention group.
Assessment will be at baseline, treatment completion and six month follow-up.
Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood.
Secondary outcome measures are: function, participation and bothersomeness of limitations.
Improvements in primary and secondary outcomes will result through the impact on self efficacy, patient activation, catastrophizing and social support.
The investigation will also provide unique and valuable information regarding patients' acceptance and use of peer visitation and self-management following limb loss.
Relevance: By establishing the utility and effectiveness of the enhanced self-management intervention, there is the potential to improve the health, activity, participation and quality of life for individuals with disabilities.
The intervention addresses the areas of activity and participation in such a way that it can be implemented in local health care facilities working in combination with a national consumer based organization - the Amputee Coalition of America.
Tipo de estudio
Intervencionista
Inscripción (Actual)
400
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21239
- Good Samaritan Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adults (aged 18-85 years) of both sexes and all races admitted to one of the seven participating acute care hospitals or rehabilitation facilities for an amputation procedure and/or treatment immediately following an amputation procedure, including traumatic amputations as well as amputations due to complications for diabetes mellitus, peripheral vascular disease, and malignancy.
- Women and minority patients will be represented in the trial according to the gender and race/ethnic prevalence of patients receiving treatment at the designated hospital and rehabilitation centers.
Exclusion Criteria:
Criteria for exclusion from the study will include:
- Age less than 18 or over 85 years; and
- Inability to communicate in written or spoken English.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Primary outcome measures are: pain, depressed mood, and positive mood.
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Medidas de resultado secundarias
Medida de resultado |
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Secondary outcome measures are: function, participation and bothersomeness of limitations
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Stephen T Wegener, PHD, Johns Hopkins University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2007
Finalización primaria (Actual)
1 de agosto de 2009
Finalización del estudio (Actual)
1 de agosto de 2009
Fechas de registro del estudio
Enviado por primera vez
14 de marzo de 2007
Primero enviado que cumplió con los criterios de control de calidad
14 de marzo de 2007
Publicado por primera vez (Estimar)
15 de marzo de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de diciembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
12 de diciembre de 2017
Última verificación
1 de diciembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CDC R01DD000153
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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