- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00525304
A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition.
Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21201
- Fayette Street Clinics
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Current documented chart diagnosis of at least one chronic medical condition
- Received clinic services for a minimum of 3 months prior to study entry
- English-speaking
- Willing to use an effective form of birth control throughout the study if sexually active
Exclusion Criteria:
- History of a serious neurological disorder or head trauma with loss of consciousness
- Diagnosed with mental retardation or dementia
- Diagnosed with end stage organ disease
- Currently receiving chemotherapy and/or radiation treatment for cancer
- Received psychiatric hospitalization less than 3 months prior to study entry date
- Blind and/or deaf
- Pregnant
- Infected with HIV with a CD4 count under 350
- Diagnosis of AIDS
- Diagnosis of anorexia
- Problematic substance use, as defined by a mental health provider
- Psychiatric instability, as defined by a mental health provider
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 |
|---|---|
|
Experimental: 1
Participants will receive a self-management program for chronic illness
|
Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
|
|
Sin intervención: Usaual Care
Usual Care; no additional intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Health-related self-efficacy and recovery orientation
Periodo de tiempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical illness self-management skills
Periodo de tiempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Social and communication skills during interactions with health care providers
Periodo de tiempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Physical and mental health status
Periodo de tiempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical service use patterns
Periodo de tiempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Medication use
Periodo de tiempo: Measured throughout the study
|
Measured throughout the study
|
|
Neurocognition
Periodo de tiempo: Measured at baseline
|
Measured at baseline
|
|
Substance abuse
Periodo de tiempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Psychiatric symptoms
Periodo de tiempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Amount and seriousness of related comorbidities
Periodo de tiempo: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Quantitative and qualitative survey ratings
Periodo de tiempo: Measured throughout the study
|
Measured throughout the study
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Richard W. Goldberg, PhD, University of Maryland, College Park
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 (Actual)
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
- HP-00040526
- DAHBR 96-BHB
- R34MH078168 (Subvención/contrato del NIH de EE. UU.)
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. .