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Mood and Diabetes Empowerment & Improvement Training (MADE-IT)

27 de maio de 2015 atualizado por: Dr. Jeanne Miranda, University of California, Los Angeles

University of California, Los Angeles (UCLA)/Drew Project EXPORT: Mood and Diabetes Empowerment & Improvement Training (MADE IT)

In this project, investigators examine the impact of a mood treatment enhanced diabetes self-care intervention for depressed, low-income Latino diabetics. The investigators hypothesize that the mood treatment enhancement will lead to significant improvement in both diabetes and depression outcomes as compared with the self-care intervention alone.

Visão geral do estudo

Status

Concluído

Descrição detalhada

The Phase I pilot recruited older Latinos from Dr. Mangione's previous study (who agreed to participate in future research) and 10 participants from a community settings. Those with low mood and poor glycemic control were offered a 12-week intervention combining cognitive behavioral therapy mood management techniques and diabetes self-care into one seamless intervention. Drs. Mangione and Miranda supervised and reviewed (through audiotapes) well-trained health educators conducting the intervention sessions. The study manuals were modified following this Phase I pilot intervention.

The final intervention manual was tested in a randomized trial in Phase II, compared the Mood and Diabetes Empowerment and Improvement Training intervention with enhanced care as usual (providing participants with a letter regarding their mood and hemoglobin (Hb)A1c with recommendations for improving care for their provider). The target population was low-income Latinos with depression and poor glycemic control. Both mood and diabetes outcomes are evaluated.

Tipo de estudo

Intervencional

Inscrição (Real)

121

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

    • California
      • Los Angeles, California, Estados Unidos, 90095
        • UCLA Psychr & Biobehav Sci

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

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

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Latino men and women age 50 and older
  • Must speak English or Spanish
  • Hb A1c greater than or equal to 8%
  • Currently not taking medication for depression
  • A score of 5 or greater on the Geriatric Depression Scale (GDS)

Exclusion Criteria:

  • Persons who are legally blind, dialysis dependent, diagnosed with dementia, and/or with hemiparesis from a cerebral vascular accident
  • Do not have sufficient hearing or cognitive function

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Wait-listed Control Group
Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
Experimental: Empowerment and CBT Classes
Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants will learn a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change "experiments" designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.
Participants randomized to the intervention arm will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers "Understanding Depression and Diabetes", Module 2 "How Thoughts Affect Your Mood and Diabetes Care", Module 3 "How Activities Affect Your Mood and Diabetes Care". The Diabetes Empowerment Module covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources.
Outros nomes:
  • CBT Classes
  • Diabetes Classes

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Hemoglobin A1c at 6 Months
Prazo: Baseline and 6 months
Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.
Baseline and 6 months
Change From Baseline in Depression Measures at 6 Months
Prazo: Baseline and 6 months

The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression.

The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression.

Baseline and 6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Blood Pressure at 6 Months
Prazo: Baseline and 6 months
Baseline and 6 months
Change From Baseline in Low Density Lipoprotein-C at 6 Months
Prazo: Baseline and 6 months
Baseline and 6 months
Change From Baseline in EQ-5D at 6 Months
Prazo: Baseline and 6 months

The EQ-5D measures general quality of life. The index score is based on 5 questions about mobility, self-care, pain, usual activities, and psychological status. The EuroQol Group provides a U.S. preference-weighted algorithm to calculate the index scores. A score of 1 indicates no problems while a score of -0.11 indicates severe problems.

The scale score is based on a visual analog of a thermostat, where 0 represents worst imaginable health and 100 represents best imaginable health. Patients mark a tick for where they feel their health is on that scale.

Baseline and 6 months
Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months
Prazo: Baseline and 6 months
The Yale Physical Activity Scale measures physical function and activities of daily living. Five activity indices (vigorous activity, leisurely walking, moving, standing and sitting) are calculated by multiplying the frequency of activity with the duration and a weighted factor. The 5 indices are then summed to create an index summary. Higher scores indicate more activity. The minimum and maximum scores are 0 and 142.
Baseline and 6 months
Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months
Prazo: Baseline and 6 months
The Diabetes Empowerment Scale Short Form (DES-SF) measures diabetes-related psychosocial self-efficacy. The questionnaire presents 8 statements on self-efficacy where participants rate how strongly they agree. The answers are summed to create a score where higher scores indicate more empowerment. The score range is 0 to 8.
Baseline and 6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Jeanne Miranda, PhD, UCLA Psychr & Biobehav Sci

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 2009

Conclusão Primária (Real)

1 de janeiro de 2012

Conclusão do estudo (Real)

1 de janeiro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

1 de agosto de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de dezembro de 2013

Primeira postagem (Estimativa)

13 de dezembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

1 de junho de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de maio de 2015

Última verificação

1 de maio de 2015

Mais Informações

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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