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Incentives for Internet-based Adherence to SMBG for Teens With T1D

18 de diciembre de 2015 actualizado por: Rowan University

Incentives for Internet-based Glucose Testing in Adolescent Type 1 Diabetes

Self-management of diabetes can result in long-term benefits, such as delaying or preventing the development of a number of unnecessary health complications, and can even reduce the chances of premature death. Because adherence to diabetes self-management often declines during adolescence, it is critically important to develop interventions that increase adherence of diabetes self-management skills in this population.

Descripción general del estudio

Descripción detallada

Intensive glycemic control among diabetics decreases the risk of both the development and progression of a number of medical complications associated with diabetes. Self-monitoring blood glucose is a critical component of diabetes self-management and is correlated with improvements in glycemic control. Nevertheless, adherence to blood glucose monitoring is generally poor, particularly among youth, with one study reporting that only ~ 25% of adolescents adhered to the recommended frequency of blood glucose testing.

The current study will use a powerful, scientifically-based behavioral intervention - contingency management (CM) to increase self-monitoring of blood glucose and improve glycemic control among adolescents with Type 1 diabetes. CM involves giving incentives for objective evidence of a target behavior and has been shown to have a robust and reliable impact in promoting behavior change. Our previous research used the Internet to objectively monitor smoking and reinforce smoking cessation (via video recorded carbon monoxide submissions), which resulted in robust increases in smoking abstinence. The current proposal extends this effective Internet-based CM intervention to address the significant health issue of non-adherence to blood glucose testing and glycemic control among youth. Two groups of non-adherent adolescents will be recruited. One group will earn incentives over the Internet for submitting webcam recorded videos that show them testing their blood glucose. A different group will be given standard care recommendations for blood glucose testing and management and will be encouraged to submit glucose monitoring videos, but incentives will not be delivered contingent on submissions (instead, they will earn monetary incentives independent of video submissions, but in an overall amount that matches the earnings of a participant in the other group). The purpose of the study is to evaluate the feasibility, convenience, and efficacy of using Internet-based CM to increase blood glucose monitoring in adolescent Type 1 diabetics.

Combining the accessibility of the Internet with a powerful, evidence-based behavioral intervention can have profound effects on adherence to diabetes self-management in this important population. Improving adherence to diabetes management in adolescents is a significant public health issue - serious medical complications, such as heart disease and nerve damage, that would develop with poor glycemic control can be avoided. Importantly, the current study offers a scientifically-based behavioral intervention that could be applied to a range of populations and behavior relevant to adherence with diabetes regimens (e.g., adults, medication adherence, carbohydrate counting, insulin dose adjustment, etc.).

Tipo de estudio

Intervencionista

Inscripción (Actual)

52

Fase

  • No aplica

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

13 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosed with Type 1 diabetes for at least one year
  • Self-reported self-monitoring blood glucose less than four times per day
  • Lived in a home with Internet access
  • No travel plans within 2 months of enrolling in the study
  • Read and spoke English

Exclusion Criteria:

  • Diagnosis other Type 1 diabetes within one year of screening
  • Not attending regular clinic appointment within 3 months of screening

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
Experimental: Contingent
Participants in this group received incentives contingent on meeting pre-specified daily blood-glucose testing adherence goals.
Blood glucose monitoring was verified by videos uploaded to a secure server. Participants in the experimental group received incentives for adherence whereas participants in the control group received adherence independent of adherence.
Comparador activo: Noncontingent
Participants in this group received incentives independent of meeting pre-specified daily blood glucose testing adherence goals.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Daily frequency of self-monitoring blood glucose
Periodo de tiempo: 45 days
45 days
Percentage of days conducted at least 4 tests per day.
Periodo de tiempo: 45 days
45 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acceptability of the intervention
Periodo de tiempo: 45 days
This was measured using a Treatment Acceptability Questionnaire
45 days
Feasibility
Periodo de tiempo: 45 days
Feasibility was based on willingness to participate (recruitment), adherence with the video submission protocol, and attrition
45 days

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Bethany Raiff, PhD, Rowan University

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 abril de 2011

Finalización primaria (Actual)

1 de diciembre de 2012

Finalización del estudio (Actual)

1 de diciembre de 2012

Fechas de registro del estudio

Enviado por primera vez

17 de diciembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

18 de diciembre de 2015

Publicado por primera vez (Estimar)

23 de diciembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

23 de diciembre de 2015

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

18 de diciembre de 2015

Última verificación

1 de diciembre de 2015

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • R21HD061683-02 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Only upon request

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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