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Cardiovascular Disease Education and Problem-Solving Training in People With Type 2 Diabetes (DECIDE)

11 de mayo de 2015 actualizado por: Felicia Hill-Briggs, Johns Hopkins University

Randomized Trial of CVD Education and Problem-Solving Training in Urban Diabetics

The purpose of this study is to determine if patient education and problem-solving training, delivered in self-study, group, and individual intervention modalities, will produce substantial improvements in CVD risk profile via improved self management in urban African Americans with type 2 diabetes and a high CVD risk profile.

Descripción general del estudio

Descripción detallada

African Americans with type 2 diabetes suffer excess disease burden, but cardiovascular disease (CVD) risk factors such as hyperglycemia, hypertension, and dyslipidemia are modifiable with medical management and lifestyle modification. Patient diabetes education and counseling for behavior change are recommended standards of practice to facilitate effective self-management of these risk factors. However, for patients with low literacy or health literacy, accessibility and impact of educational and behavioral interventions are limited. Pilot research suggests that: a) literacy demand and behavioral activation characteristics of patient education modules can be adapted to facilitate learning in urban patients with low literacy, and b) combining literacy-adapted education with problem-solving training facilitates understanding and use of health information for performing self-management in the context of daily life (functional health literacy). Optimal modalities for delivery of a combined patient diabetes education and problem-solving training, and cost-effectiveness of this intervention model, however, are not known. The proposed study will address these needs by testing effectiveness and cost-effectiveness of literacy-adapted diabetes and CVD education and problem-solving training interventions in urban African Americans with type 2 diabetes and high CVD risk profile (suboptimal blood sugar, blood pressure, and/or lipids). The specific aims of the study are: a) to complete development of a package of literacy-adapted diabetes and CVD patient education materials by developing two video/DVDs addressing self-management recommendations appropriate to the needs, resources, and environment of the population; b) to randomize urban African-American adults with type 2 diabetes and a high CVD risk profile into one of four study arms: Usual Care (Arm 1), Literacy-Adapted Education and Problem-Solving Training Self-Study (Arm 2), Literacy-Adapted Education and Group Problem-Solving Training (Arm 3), and Literacy-Adapted Education and Individual Problem-Solving Training (Arm 4); c) to conduct baseline, 3-month post-intervention, and 6-month post-intervention assessment visits to analyze and compare effectiveness of the literacy-adapted education and problem-solving interventions, as compared to Usual Care, in improving the skills of knowledge, problem-solving and health literacy, behaviors of patient activation and diabetes self-management, and clinical outcomes of A1C, blood pressure and lipids; and d) to perform a cost-effectiveness analysis of each intervention arm as compared to Usual Care. If proven effective, this research will yield low literacy diabetes and CVD patient education and self-management intervention tools for dissemination to high-risk urban minority populations. Moreover, the cost-effectiveness analysis will provide evidence to support decision-making regarding implementation of the models to achieve cardiovascular disease patient self-management goals in clinical practice.

Tipo de estudio

Intervencionista

Inscripción (Actual)

382

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Johns Hopkins School of Medicine/General Clinical Research Center
      • Baltimore, Maryland, Estados Unidos, 21224
        • Johns Hopkins Bayview Medical Center/General Clinical Research Center
      • Baltimore, Maryland, Estados Unidos, 21287
        • Johns Hopkins School of Medicine/General Internal Medicine

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

25 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 25 years or older

    • Type 2 diabetes determined by physician diagnosis or self-report of type 2 diabetes confirmed by medical documentation or medication review
    • Black/African American by self-report
    • currently receiving care and able to provide contact information for a treating physician
    • residing in Baltimore, Maryland.

Exclusion Criteria:

  • Mentally incompetent to give informed consent
  • Severe cognitive impairment on the Telephone Interview for Cognitive Status
  • Unable to complete assessment (interview, tests, venipuncture)
  • Comorbid conditions likely to lead to death in the next 3-5 years (e.g. cancer, AIDS, end-stage renal disease, active tuberculosis, Alzheimer's disease)
  • Planning to relocate from Baltimore region during the time period of the study or other reasons rendering person unable to attend visits to participate in intervention and follow-up assessments

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Usual Care
Packet of standard print patient education materials on CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA).
  • Packet of print patient education materials about CVD and diabetes from the American Heart Association (AHA) and the American Diabetes Association (ADA)given at baseline following randomization to Arm 1
  • Scripted set of instructions will be given along with a verbal description of the materials and the content provided.
Otros nombres:
  • Standard Print Education Materials
  • Project DECIDE Usual Care
Experimental: Self Study
One 90-minute educational session. Print materials and DVDs for self-study
  • Education + Problem-Solving Training Self-Study
  • One session of Literacy-Adapted Diabetes and CVD Risk Education
  • Instructions and a schedule for use of the Literacy-Adapted Problem-Solving Workbook for self-study will be given to each participant.
Otros nombres:
  • Self-Management Training Self-Study
  • Project DECIDE Self-Study
Experimental: Group Problem-Solving Training
One 90-minute education session. Group problem-solving training (eight, 90-minute sessions)
  • Education + Group Problem-Solving Training
  • One session of the Literacy-Adapted Diabetes and CVD Risk Education
  • Group problem-solving training eight, 90-minute sessions
Otros nombres:
  • Group Self-Management Training
  • Project DECIDE Group Training
Experimental: Individual Problem-Solving Training
One 90-minute education session. Individual problem-solving training (eight, 60-minute sessions)
  • Education + Individual Problem-Solving Training
  • One session of the Literacy-Adapted Diabetes and CVD Risk Education
  • Individual problem-solving training (eight, 60-minute sessions)
Otros nombres:
  • Individual Self-Management Training
  • Project DECIDE Individual Training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
HbA1C
Periodo de tiempo: Screening, 3 months post intervention, 6 months post-intervention
Screening, 3 months post intervention, 6 months post-intervention

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Blood pressure
Periodo de tiempo: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Lipid Panel
Periodo de tiempo: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Body Mass Index
Periodo de tiempo: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Health Problem Solving Scale
Periodo de tiempo: Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Diabetes and CVD Knowledge Test
Periodo de tiempo: Screening, 3 months post-intervention, 6 months post-intervention
Screening, 3 months post-intervention, 6 months post-intervention
Patient Activation Measure
Periodo de tiempo: Baseline, 3 months post-intervention, 6 months post-intervention
Baseline, 3 months post-intervention, 6 months post-intervention
Summary of Diabetes Self-Care Activities Scale
Periodo de tiempo: Baseline, 3 months post-intervention, 6 months post-intervention
Baseline, 3 months post-intervention, 6 months post-intervention
Barriers to Self-Management
Periodo de tiempo: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Felicia Hill-Briggs, PhD, ABPP, Johns Hopkins School of Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2010

Finalización primaria (Actual)

1 de febrero de 2014

Finalización del estudio (Actual)

1 de febrero de 2014

Fechas de registro del estudio

Enviado por primera vez

24 de agosto de 2009

Primero enviado que cumplió con los criterios de control de calidad

24 de agosto de 2009

Publicado por primera vez (Estimar)

25 de agosto de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de mayo de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

11 de mayo de 2015

Última verificación

1 de mayo de 2015

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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