Training and Supervision Program for Depression Management
Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A cluster randomized controlled clinical trial will be conducted in four Primary Health Care (PHC) clinics in Santiago, Chile.
The sample selection of the PHC clinics will be performed in two steps. Firstly, two urban municipalities of Santiago Metropolitan Region, Chile, will be randomly selected if they work with the Faculty of Medicine of the U.Chile and have at least two PHC.Municipalities with a high Human Development Index, high percentage of immigrants and older population, and Psychiatry residents working in PHC , will be excluded.Secondly in each selected municipalities,two PHC will be randomly selected for the active and control arm.
To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, 152 depressed persons, 76 to each group, will be required for the study. A design effect of 2.42 was estimated. After applying the design effect the sample needed increased to 368 depressed persons. Considering a retention rate of approximately 85%, 434 depressed cases will be needed required for the study, hence 109 cases in each of the 4 primary health care clinics.
Analysis and presentation of the results will be in accordance with CONSORT guidelines for randomized clinical trials, with the primary comparative analysis being conducted on an intention to treat basis and due emphasis placed on confidence intervals for the between-arm comparisons.
Initially descriptive analysis to assess the balance between two groups will be conducted. The primary analysis will employ multilevel multivariable lineal regression to investigate differences in the PHQ-9 scores between groups at 3 and 6 months after randomization, adjusting for baseline outcome variable scores. Sensitivity analysis making different assumptions will be conducted to investigate the potential effects of missing data. Similar analysis will be done for the secondary outcomes measures.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Santiago
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Quinta Normal, Santiago, Chile
- CESFAM Garín
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Quinta Normal, Santiago, Chile
- CESFAM Lo Franco
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San Miguel, Santiago, Chile
- CESFAM Barros Luco
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San Miguel, Santiago, Chile
- CESFAM Recreo
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- signing written informed consent
- age between 18-65 years
- current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)
Exclusion Criteria:
- current depression treatment
- no access to telephone
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Depression training/supervision program
A complex intervention, which will include:
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The intervention will be composed of:
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Sin intervención: Usual Care
Patients in the control group will receive all the interventions that are guaranteed for persons with depression in Chile: treatment in Primary Health Care clinics with the Primary Health Care team and referral to the regional specialized psychiatric service.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline Depressive Symptomatology at 3 months
Periodo de tiempo: Baseline , 3 months
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Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.
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Baseline , 3 months
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Change from Baseline Depressive Symptomatology at 6 months
Periodo de tiempo: Baseline, 6 months.
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Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.
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Baseline, 6 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adherence to depression treatment at patient's level
Periodo de tiempo: 3 and 6 months after baseline.
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3 and 6 months after baseline.
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Change from Baseline Quality of life at 3 and 6 months
Periodo de tiempo: Baseline , 3 months, 6 months.
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Quality of life at patient's level measured with the Health Survey, Short form (SF-36), at 3 months and 6 months after patient recruitment.
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Baseline , 3 months, 6 months.
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Change from Baseline Clinical Outcomes at 3 and 6 months
Periodo de tiempo: Baseline , 3 months, 6 months.
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Clinical outcomes at patient's level measured with the Outcome Questionnaire-45.2 (OQ-45.2),
at 3 months and 6 months after patient recruitment.
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Baseline , 3 months, 6 months.
|
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Use of Health Care services at patient's level
Periodo de tiempo: 3 and 6 months after baseline
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Use of Health Care services at patient's level measured with and ad-hoc built questionnaire.
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3 and 6 months after baseline
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Rate of treated depressed cases at Primary Care team level
Periodo de tiempo: 12 months before randomization and 12 months after.
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12 months before randomization and 12 months after.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- 1130230
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