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- Ensayo clínico NCT00964587
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
Estado
Terminado
Condiciones
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
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins School of Medicine/General Clinical Research Center
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Bayview Medical Center/General Clinical Research Center
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins School of Medicine/General Internal Medicine
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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 |
|---|---|
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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).
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Otros nombres:
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Experimental: Self Study
One 90-minute educational session.
Print materials and DVDs for self-study
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Otros nombres:
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Experimental: Group Problem-Solving Training
One 90-minute education session.
Group problem-solving training (eight, 90-minute sessions)
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Otros nombres:
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Experimental: Individual Problem-Solving Training
One 90-minute education session.
Individual problem-solving training (eight, 60-minute sessions)
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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HbA1C
Periodo de tiempo: Screening, 3 months post intervention, 6 months post-intervention
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Screening, 3 months post intervention, 6 months post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Blood pressure
Periodo de tiempo: Screening, 3 months post-intervention, 6 months post-intervention
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Screening, 3 months post-intervention, 6 months post-intervention
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Lipid Panel
Periodo de tiempo: Screening, 3 months post-intervention, 6 months post-intervention
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Screening, 3 months post-intervention, 6 months post-intervention
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Body Mass Index
Periodo de tiempo: Screening, 3 months post-intervention, 6 months post-intervention
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Screening, 3 months post-intervention, 6 months post-intervention
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Health Problem Solving Scale
Periodo de tiempo: Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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Screening, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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Diabetes and CVD Knowledge Test
Periodo de tiempo: Screening, 3 months post-intervention, 6 months post-intervention
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Screening, 3 months post-intervention, 6 months post-intervention
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Patient Activation Measure
Periodo de tiempo: Baseline, 3 months post-intervention, 6 months post-intervention
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Baseline, 3 months post-intervention, 6 months post-intervention
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Summary of Diabetes Self-Care Activities Scale
Periodo de tiempo: Baseline, 3 months post-intervention, 6 months post-intervention
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Baseline, 3 months post-intervention, 6 months post-intervention
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Barriers to Self-Management
Periodo de tiempo: Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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Baseline, 1 week post-intervention, 3 months post-intervention, 6 months post-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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
- Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behav Med. 2003 Summer;25(3):182-93. doi: 10.1207/S15324796ABM2503_04.
- Hill-Briggs F, Gemmell L. Problem solving in diabetes self-management and control: a systematic review of the literature. Diabetes Educ. 2007 Nov-Dec;33(6):1032-50; discussion 1051-2. doi: 10.1177/0145721707308412.
- Hill-Briggs F, Smith AS. Evaluation of diabetes and cardiovascular disease print patient education materials for use with low-health literate populations. Diabetes Care. 2008 Apr;31(4):667-71. doi: 10.2337/dc07-1365. Epub 2008 Jan 17.
- Hill-Briggs F, Gemmell L, Kulkarni B, Klick B, Brancati FL. Associations of patient health-related problem solving with disease control, emergency department visits, and hospitalizations in HIV and diabetes clinic samples. J Gen Intern Med. 2007 May;22(5):649-54. doi: 10.1007/s11606-006-0091-2.
- Hill-Briggs F, Renosky R, Lazo M, Bone L, Hill M, Levine D, Brancati FL, Peyrot M. Development and pilot evaluation of literacy-adapted diabetes and CVD education in urban, diabetic African Americans. J Gen Intern Med. 2008 Sep;23(9):1491-4. doi: 10.1007/s11606-008-0679-9. Epub 2008 Jun 3.
- Majid HM, Schumann KP, Doswell A, Sutherland J, Hill Golden S, Stewart KJ, Hill-Briggs F. Development and evaluation of the DECIDE to move! Physical activity educational video. Diabetes Educ. 2012 Nov-Dec;38(6):855-9. doi: 10.1177/0145721712462748. Epub 2012 Oct 4. Erratum In: Diabetes Educ. 2013 Jul-Aug;39(4):586.
- Hill-Briggs F, Schumann KP, Dike O. Five-step methodology for evaluation and adaptation of print patient health information to meet the < 5th grade readability criterion. Med Care. 2012 Apr;50(4):294-301. doi: 10.1097/MLR.0b013e318249d6c8.
- Fitzpatrick SL, Schumann KP, Hill-Briggs F. Problem solving interventions for diabetes self-management and control: a systematic review of the literature. Diabetes Res Clin Pract. 2013 May;100(2):145-61. doi: 10.1016/j.diabres.2012.12.016. Epub 2013 Jan 9.
- Fitzpatrick SL, Golden SH, Stewart K, Sutherland J, DeGross S, Brown T, Wang NY, Allen J, Cooper LA, Hill-Briggs F. Effect of DECIDE (Decision-making Education for Choices In Diabetes Everyday) Program Delivery Modalities on Clinical and Behavioral Outcomes in Urban African Americans With Type 2 Diabetes: A Randomized Trial. Diabetes Care. 2016 Dec;39(12):2149-2157. doi: 10.2337/dc16-0941.
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01HL089751-01A1 (Subvención/contrato del NIH de EE. UU.)
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. .