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Diabetes Pueblo Program - Application and Acceptability of Culturally Appropriate Latino Education for Insulin Therapy (DiabPueblo)

2 de setembro de 2021 atualizado por: Sansum Diabetes Research Institute

Diabetes Pueblo Program - The Application and Acceptability of Culturally Appropriate Education Programs for Current or Potential Insulin Therapy Users With Type 2 Diabetes in the Latino Community

Currently in the United States, the achieved level of glycemic control for adult Latinos with type 2 diabetes (T2D) is sub-optimal compared to the non-Latino Caucasian population. Among Latinos with T2D, there are unique barriers, such as socioeconomic and cultural factors, to starting and optimizing therapies, including insulin. Latinos have cultural beliefs and behaviors specific to this population that should be appropriately addressed in a diabetes self-management education and support program. Diabetes Pueblo is a diabetes education program that may be a solution to help address the barriers Latinos with T2D have to diabetes care and insulin use. The Diabetes Pueblo program consists of two targeted diabetes education curriculums for the local Latino community: (a) Diabetes Fundamentals and (b) Insulin Success, a culturally appropriate program course addressing barriers to initiating and optimizing insulin and T2D therapies. We will explore if Diabetes Pueblo Program improves knowledge of lifestyle advice for healthy eating and physical activity, increase the propensity to use insulin when clinically indicated, and improve success rates with insulin therapy by addressing common fears and negative perceptions of T2D therapies in this population.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Diabetes mellitus (DM) is a group of chronic disorders typified by raised blood glucose levels. An estimated 30 million people in the United States (US) (9.4% of the population) have diabetes. Type 1 diabetes (T1D) is defined by a rapid onset, often in childhood, and insulin dependence; while type 2 diabetes (T2D) is considered to have a slow onset and insulin insensitivity. Insulin is a required form of treatment for all T1D, and T2D patients who cannot achieve glycemic control through exercise and diet or other medications alone. Currently in the United States, the achieved level of glycemic control for adult Latinos with type 2 diabetes (T2D) is sub-optimal compared to the non-Latino Caucasian population. Among Latinos with T2D, there are unique barriers to starting and optimizing therapies, including insulin. Barriers include socioeconomic and cultural factors, as well as inadequate encouragement from health care providers. There are also challenges associated with access to timely and appropriate diabetes education. Some of these barriers may improve by using trained community health workers from the Latino community, as there is evidence that they are effective in supporting adherence and persistence with therapies (including insulin) and in encouraging lifestyle changes for T2D patients within their own communities.

The 2017 National Standards of Care for Diabetes Self-Management Education and Support (DSME/S) outline quality, evidenced based guidelines for DSME/S programs and guide those who will be providing these services. Benefits of DSME/S programs include improved clinical outcomes such as HbA1c and quality of life while reducing hospitalizations and health care costs. Hispanics are known to have a higher prevalence of diabetes, but use of DSME/S programs are vastly underutilized which means that many individuals in the Latino community with T2D are likely not receiving critical DSME/S services. It is crucial that DSME/S services be aligned with the needs of the target population in order to increase adherence and improve health outcomes. Latinos have cultural beliefs and behaviors specific to this population that should be appropriately addressed in a DSME/S program.

Diabetes Pueblo is a diabetes education program that may be a solution to help address the barriers Latinos with T2D have to diabetes care and insulin use. The Diabetes Pueblo program consists of two targeted diabetes education curriculums for the local Latino community: (a) Diabetes Fundamentals and (b) Insulin Success, a culturally appropriate program course addressing barriers to initiating and optimizing insulin and T2D therapies. Trained community health workers, also known as promotores, will deliver both programs. Ultimately, we will explore if Diabetes Pueblo Program improves knowledge of lifestyle advice for healthy eating and physical activity, increase the propensity to use insulin when clinically indicated, and improve success rates with insulin therapy by addressing common fears and negative perceptions of T2D therapies in this population.

This is a prospective pilot study. The Diabetes Pueblo program applied in this study is one program that consists of two newly created, targeted education curriculums for T2D Latino adults delivered over the course of 11 weeks by designated promotores, community health workers, to approximately 20 study participants at Sansum Diabetes Research Institute.

Tipo de estudo

Intervencional

Inscrição (Real)

25

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
      • Santa Barbara, California, Estados Unidos, 93463
        • Sansum Diabetes Research Institute

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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Individuals > 18 years of age
  2. Self-reported Latino heritage
  3. Fluent in Spanish
  4. Type 2 diabetes diagnosis
  5. Available to attend the educational series and all study visits
  6. Willingness to have height, weight, waist circumference, and HbA1c measured before and after the educational course
  7. Individuals with poor glycemic control, as defined by the following:

    • HbA1c ≥ 8% at or prior to enrollment assessment (most recent lab within 3 months or provided at Sansum Diabetes Research Institute (SDRI) screening visit),

    OR

    • HbA1c < 8% (within the last 3 months), AND with at least one of the following (also within the last 3 months):

      • Fasting plasma glucose ≥ 130 mg/dL
      • 2-hour post-prandial or random blood glucose ≥ 180 mg/dL
      • ≥1 hypoglycemic event (blood glucose < 70 mg/dL)

    OR

    • Individuals new to insulin or being considered for insulin therapy by their healthcare provider
  8. Willing and able to provide consent to take part in the study
  9. Based on the research staff's judgment, participant must have a good understanding, ability, and willingness to adhere to the protocol

Exclusion Criteria:

  1. Has a cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, medical condition, or insufficient knowledge of the education program language that, in the opinion of the screener, would interfere with the ability to provide consent and participate/complete the program
  2. Participation in other studies involving medications or device within 3 months prior to Visit 1
  3. Known or suspected abuse of alcohol, narcotics, or illicit drugs
  4. Current use of insulin pump
  5. For females: Pregnancy or positive pregnancy test
  6. Pharmaceutical employees or those employed in a position where they have a direct role in treating participants with diabetes.

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Latino adults with type 2 diabetes

Participants of the Diabetes Pueblo Education Program will include adults with T2D from the Santa Barbara Latino community whose diabetes is poorly controlled, defined as -

  1. hemoglobin A1c > 8% at or prior to enrollment, or
  2. hemoglobin A1c < 8% (within the last 3 months), AND with at least one of the following (also within the last 3 months):

    • Fasting plasma glucose > 130 mg/dL
    • 2-hour post-prandial or random blood glucose > 180 mg/dL
    • > 1 hypoglycemic event (blood glucose < 70 mg/dL) , or
  3. adults with T2D from the community who are new to insulin or being considered for insulin therapy by their healthcare provider.
These adults will receive diabetes education, the Diabetes Pueblo Program, and will complete Curriculum (A), Diabetes Fundamentals, and Curriculum (B), Insulin Success.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Success (evaluated by a Yes/No format) recruiting and completing a new targeted diabetes and insulin education program, Diabetes Pueblo, for Latino adults with type 2 diabetes.
Prazo: 11 weeks
The Diabetes Pueblo program consists of two newly created, targeted education curriculums, Diabetes Fundamentals and Insulin Success, for Latino adults with type 2 diabetes. It will be delivered over the course of 11 weeks by designated promotores, community health workers, to approximately 20 study participants at Sansum Diabetes Research Institute.
11 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Diabetes self management evaluated by questionnaire
Prazo: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class
The Diabetes Self-Management Questionnaire consists of 16 questions to evaluate diabetes self-care including glucose management, dietary control, physical activity, and health-care use. Questions are rated on a 4 point scale - 0 Does not apply to me, 1 Applies to me to some degree, 2 Applies to me to a considerable degree, 3 Applies to me very much. This yields an overall rating of self-care with higher scores indicating more effective diabetes self-care.
Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class
Insulin treatment evaluated by questionnaire
Prazo: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
The Insulin Treatment Appraisal Scale is a validated 20-item questionnaire that will be used in insulin naïve and insulin-treated patients with type 2 diabetes to assess positive and negative perceptions regarding insulin treatment. Items are rated on a 5-point scale ("strongly disagree" to "strongly agree") and the mean of individual item scores is calculated to obtain a total score, with lower scores indicating less negative perceptions regarding insulin treatment.
Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Participant evaluation of Diabetes Pueblo evaluated by questionnaire
Prazo: Class 4, week 4; Class 8, week 8; Class 10, week 10
The first questionnaire includes curriculum content questions which are specific to courses 1-4, 5-8, and 9-10.
Class 4, week 4; Class 8, week 8; Class 10, week 10
Participant evaluation of Diabetes Pueblo evaluated by questionnaire
Prazo: Class 11, week 11
The second questionnaire assesses overall program feedback on the entire program.
Class 11, week 11

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Fingerstick for evaluation of HbA1c related to diabetes
Prazo: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
HbA1c % will measured in a capillary fingerstick blood sample
Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Height measured by Physical exam
Prazo: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Height measured in centimeters or inches by physical exam
Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Weight measured by Physical exam
Prazo: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Weight measured in kilograms or pounds by physical exam
Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Waist circumference measured by Physical exam
Prazo: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Waist circumference measured in centimeters or inches by physical exam
Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Socio-demographics assessed by questionnaire
Prazo: Visit 1, week 0 Screening
Socio-demographics measured by questionnaire - including age, gender, self-identified race/ethnicity, contact information, education, occupation, preferred language, insurance status, influenza & pneumonia immunization status, alcohol & tobacco use, birth place, physical activity, food security, and mobile phone use.
Visit 1, week 0 Screening
Foot examination evaluated by Questions
Prazo: Visit 1, week 0 Screening
Foot examination with 'yes or no' and frequency questions
Visit 1, week 0 Screening
Neuropathy Questions
Prazo: Visit 1, week 0 Screening
Questions about neuropathy
Visit 1, week 0 Screening
Retinopathy Questions
Prazo: Visit 1, week 0 Screening
Questions about retinopathy and eye exams
Visit 1, week 0 Screening
Nephropathy Questions
Prazo: Visit 1, week 0 Screening
Questions about nephropathy
Visit 1, week 0 Screening
Medical history and medication status and history assessed by questionnaire
Prazo: Visit 1, week 0 Screening
Medical history, including date of diabetes diagnosis, type of diabetes, diabetes education, diabetes self-care, depression and stress, falls, physician visits, hospital and emergency room visits, and current medications verified by visual inspection and medication history assessed by interview questionnaire
Visit 1, week 0 Screening
Menopausal status, pregnancy status, and gestational diabetes history for women determined by questionnaire
Prazo: Visit 1, week 0 Screening
Menopausal status, pregnancy status (number of live births, number of stillbirths, birthweights of live births, and any diagnosis of type 1 diabetes), and gestational diabetes history for female participants will be determined by questionnaire
Visit 1, week 0 Screening

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: Jamie Creason, RD, Sansum Diabetes Research Institute

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 (Real)

10 de maio de 2019

Conclusão Primária (Real)

25 de fevereiro de 2020

Conclusão do estudo (Real)

25 de fevereiro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

9 de julho de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de julho de 2019

Primeira postagem (Real)

11 de julho de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de setembro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de setembro de 2021

Última verificação

1 de setembro de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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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