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Training Doctors to Support Patient Self-Care of Depression

30 de novembro de 2015 atualizado por: University of California, Davis

Physician Training to Support Patient Self-Efficacy for Depression Care Behaviors

This study will determine whether practicing primary care providers (PCPs) can be trained to support patient self-care of depression and co-existing diabetes during office visits, and begin to explore whether this might improve depression and diabetes outcomes, and whether the effects of the training generalize to patients with health conditions other than depression and diabetes. This is important because most patients with chronic conditions struggle with self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Many primary care patients struggle with health behaviors that can reduce depressive symptoms, such as adhering to prescribed treatments. Bolstering patient self-efficacy can improve health behaviors and outcomes, including those related to depression. However, current self-efficacy interventions are provided outside of primary care, and so cannot harness the power of therapeutic primary care provider (PCP)-patient relationships. Teaching PCPs to employ self-efficacy enhancing interviewing techniques (SEE IT) with patients would build upon existing therapeutic relationships, greatly increasing the reach of self-efficacy enhancement. The randomized controlled trial (RCT) in this proposal will examine whether, as compared with an attention control condition, a brief (< 1 hour) office-based intervention for practicing PCPs will lead to significantly greater use of SEE IT during unannounced follow-up SP encounters (postintervention and 3 months). The interventions will be delivered to PCPs during their regular office hours by standardized patient (SP) instructors. All study SPs will portray patients with both depression and diabetes, since these conditions commonly co-occur and entail a heavy burden of health-enhancing behaviors. Exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with co-occurring depression and diabetes: self-efficacy for depression and diabetes self-care, actual self-care behaviors (e.g. medication adherence), symptom severity, and health status. Further exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with various chronic conditions (ie, not limited to depression and diabetes): self-care self-efficacy, actual self-care behaviors, symptom severity, and health status. Pre- and post-RCT focus groups with stakeholders (PCPs, office staff, patients, and SP instructors) will guide refinement of the SEE IT intervention. The proposed research activities will inform the design (e.g. sample size) and conduct of a future R01-funded, multi-center, cluster RCT of the finalized intervention, adequately powered to examine effects on a range of patient outcomes; sustainability of effects on PCP interviewing over time; and generalizability to other practice settings and common co-morbid mental health and physical illness clusters. The SEE IT intervention begins to address the broader health needs of individuals with depression in primary care, and has unique potential to reduce the tremendous burden of mental illness related morbidity and mortality.

Tipo de estudo

Intervencional

Inscrição (Real)

182

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • California
      • Sacramento, California, Estados Unidos, 95817
        • University of California Davis Health System
      • Sacramento, California, Estados Unidos, 95816
        • Sutter Health Sacramento

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria: Physicians (targeted enrollment=56; actual enrollment=50)

  • Currently in practice at a participating office within one of the 2 participating health systems (University of California Davis Primary Care Network, Sutter Sacramento Health System)
  • Trained as a family physician, general practitioner, and/or general internist
  • Able to read and speak English

Inclusion Criteria: Group of patients with diabetes and depressive symptoms (targeted enrollment=168; actual enrollment=15)

  • Receive primary health care in one of the participating offices, from one of the participating primary care physicians
  • Aged 18 years or older
  • Able to read and speak English
  • Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
  • Have concurrent diagnoses of depression and diabetes, determined via medical record review
  • Have at least mild depressive symptoms, manifested by a score of 10 or greater on a telephone-administered Patient Health Questionnaire (PHQ-9).
  • Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
  • Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider

Inclusion Criteria: Group of patients with various health conditions, ie, not limited to diabetes and depression (targeted enrollment=336; actual enrollment=117)

  • Receive primary health care in one of the participating offices, from one of the participating primary care physicians
  • Aged 18 years or older
  • Able to read and speak English
  • Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
  • Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
  • Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider

Exclusion Criteria: Patients (applies to all study patients)

  • Self-report or medical record evidence of unstable overall medical status
  • Self-report or medical record evidence of terminal illness
  • Self-report or medical record evidence of bipolar disorder, chronic psychosis (schizophrenia or other), or personality disorder
  • Self-report or medical record evidence of a history of attempted suicide
  • Planned transfer of care to a health system other than the 2 participating systems within 6 months
  • Inability to understand any of the screening questions, after appropriate explanation (e.g. due to cognitive impairment, developmental delay, or other reasons)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: SEE IT training (interviewing skills)
Intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) with patients who have coexisting depression and diabetes
Comportamental: SEE IT training
Standardized patient instructors provide a scripted intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) during office visits with patients who have coexisting depression and diabetes
Comparador Ativo: Control (knowledge enhancement)
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
Outro: Knowledge enhancement
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Physician use of self-efficacy enhancing interviewing techniques
Prazo: During the 3 months after receiving intervention
During the 3 months after receiving intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Patient self-efficacy for depression self-care
Prazo: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
Patient self-efficacy for diabetes self-care
Prazo: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
General self-care self-efficacy (all health conditions)
Prazo: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
Patient depressive symptoms
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient depression self-care behaviors
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient diabetes self-care behaviors
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient chronic illness self-care behaviors (generic)
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to depression and diabetes medications
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to chronic illness medications (generic)
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to depression counseling
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient mental health status
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient physical health status
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient glycemic control
Prazo: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Wallston Multidimensional Health Locus of Control Scale
Prazo: 5 minutes after an index visit with their primary care provider
Perceived control over health
5 minutes after an index visit with their primary care provider
Healthcare Climate Questionnaire
Prazo: 5 minutes after an index visit with their primary care provider
Patient perception of degree to which primary care provider is autonomy supportive
5 minutes after an index visit with their primary care provider

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of California, Davis

Colaboradores

National Institute of Mental Health (NIMH)

Investigadores

  • Investigador principal: Anthony Jerant, MD, University of California, Davis

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de abril de 2013

Conclusão Primária (Real)

1 de fevereiro de 2015

Conclusão do estudo (Real)

1 de maio de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

8 de maio de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de junho de 2012

Primeira postagem (Estimativa)

13 de junho de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

2 de dezembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de novembro de 2015

Última verificação

1 de novembro de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2012336397-1
  • R34MH095893 (Concessão/Contrato do NIH dos EUA)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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