- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03304535
Social Worker in an Eye-Care Service
The Impact of a Social Worker in a Glaucoma Eye-Care Service: A Prospective Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
An appointment will be scheduled for participant to meet with a social worker. The appointment may happen on day of participant's scheduled clinic appointment or on another mutually decided upon date and time. Should participant choose to participate, this first visit will be Visit 1 for the study.
Visit 1: Baseline
Informed consent will be obtained demonstrating an interest in participating.
A visit with the social worker will take place during Visit 1. This session will be held in a private office and allows participant time for discussion regarding any challenges, struggles and/or barriers they may be experiencing.
The following baseline questionnaires/surveys will be administered:
Modified Patient Activation Measure - measures participant confidence in taking care of their own health.
Distress Thermometer - measures participant distress level during the past week.
Patient Health Questionnaire -measures depression symptoms and severity if any.
Clinical information will be taken from participant's medical record. There may be follow-up questions related to data if information is unclear or incomplete.
Upon completion of Visit 1, participant will receive a satisfaction survey to evaluate how participant satisfaction with social worker interaction.
Social Worker Interventions: After Visit 1 and before Visit 2
The social worker will develop an intervention for participant during Visit 1 appointment. As many calls or in person meetings participant requires will take place. There will be no limit and it will be determined by participant's needs.
Visit 2: Follow-up After 6 Months
Upon completion of participant's six month follow-up in the study, the following questionnaires/surveys will be administered:
Modified Patient Activation Measure - measures how confident participant is at taking care of their own health.
Distress Thermometer - measures how much distress participant has been experiencing in the past week.
Patient Health Questionnaire - measures if participant has symptoms of depression and the severity of those symptoms.
Satisfaction Survey - measures how satisfied participant is with the social worker interaction.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Wills Eye Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients seen at Wills Eye Hospital in the Glaucoma Service
- Glaucoma of any type, characterized by glaucomatous optic neuropathy and corresponding visual field (VF) defect
- Referred to staff social worker for intervention
- Ability to read, write, speak and understand English
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in response to Patient Health Questionnaire 9
Periodo de tiempo: 6 months
|
Measures participant levels of depression based on questions related to depressive symptoms.
The investigator will assess change in the number of participants with major, moderate, and minimal depressive symptoms.
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in response to Distress thermometer
Periodo de tiempo: 6 months
|
Measures participant level of distress on a scale of 1 to 10 and asks additional questions regarding contributors to distress.
|
6 months
|
Change in response to Modified Patient Activation Measure 13
Periodo de tiempo: 6 months
|
Measures participant self-capacity for and confidence regarding glaucoma management.
|
6 months
|
Descriptive results of the Social Worker Baseline Assessment
Periodo de tiempo: 6 months
|
Social worker will assess each participant's internal and external barriers to care, limitations, and strengths that may help them to manage their glaucoma.
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Scott J Fudemberg, MD, Wills Eye Hospital
Publicaciones y 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 (Actual)
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
- IRB#15-XXX
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .