- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01890226
A Mobile Personal Health Record for Behavioral Health Homes (mPHR)
Poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (SMI). To address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated clinics in which persons with SMI receive coordinated medical and mental health care. However, behavioral health homes have faced logistical and privacy challenges in integrating electronic medical records across organizations.
This application proposes to develop and test a mobile Personal Health Record (mPHR) to overcome this problem while more fully engaging patients in their health care. The study will develop, test, and disseminate the mPHR. The investigators will develop the app building on experience and preliminary data from a PC-based PHR project, and link it to the medical and mental health EHR in a behavioral health home. Next, the investigators will conduct a randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Georgia
-
Conyers, Georgia, Estados Unidos, 30012
- Viewpoint Health & Oakhurst Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- one or more of the following conditions: hyperlipidemia, hypertension, diabetes
- able to give consent
- patient in the behavioral health home
Exclusion Criteria:
- Unable to give consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
|
|
|
Experimental: Experimental: Intervention
Participants randomized to the intervention arm will receive the mobile personal health record.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Composite Quality Score
Periodo de tiempo: Baseline, 12 month post intervention
|
It is a measure of quality of care.
The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator.
The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services.
|
Baseline, 12 month post intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Patient Assessment of Chronic Illness Care
Periodo de tiempo: Baseline, 6 month post intervention, 12 month post intervention
|
20-item patient self-report instrument that assesses the extent to which patients with chronic illness report receiving care that aligns with the Chronic Care Model.
The summary score ranges from 1 to 5 with a higher score indicating patient's perception of greater involvement in self-management and receipt of chronic care counseling.
|
Baseline, 6 month post intervention, 12 month post intervention
|
|
Change in Patient Activation Measure
Periodo de tiempo: Baseline, 6 month post intervention, 12 month post intervention
|
Assesses a patients' perceived ability to manage their illnesses and their healthcare visits.
Patient Activation Measure Scores were summed to calculate the overall raw score then transformed to an activation scale ranging from 0 to 100.
Higher scores indicate greater patient activation.
|
Baseline, 6 month post intervention, 12 month post intervention
|
|
Change in Health-related Quality of Life
Periodo de tiempo: Baseline, 6 month post intervention, 12 month post intervention
|
Measured using the Physical and Mental Component Summary scales of the SF-12. Assesses a patients' perceived health related quality of life. The composite physical (PCS) and mental component (MCS) summary scores for the SF-12 are each scored on a 0-100 scale. Higher scores indicate better functioning. |
Baseline, 6 month post intervention, 12 month post intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Benjamin Druss, MD, MPH, Emory University
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 (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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00067447
- 1R01MH100467-01 (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. .