Training and Supervision Program for Depression Management
Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline Depressive Symptomatology at 3 months
Prazo: 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
Prazo: 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.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adherence to depression treatment at patient's level
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1130230
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