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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01075997
The Impact of a Video Cell Phone Reminder System on Glycemic Control in Patients With Diabetes Mellitus
24 de febrero de 2010 actualizado por: Walter Reed Army Medical Center
The purpose of the study is to determine whether having a video cell phone that gives daily reminders over a 6-month period to check blood surgery and take your diabetes medications can improve your diabetes control during that time and if that benefit lasts for up to 1 year.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to determine if a cell phone video reminder system will improve compliance and glycemic control in patients with diabetes mellitus when compared with standard of care.
We plan to partner with Affinity Network, Inc., a local minority-owned small business, to provide broadband-enabled cell phone service to patients with diabetes mellitus.
Their IntelaCare™ system will host the content and transmit it to the phones on a personalized schedule.
This will be a prospective, randomized, controlled trial comparing patients with diabetes mellitus who receive daily video reminders via cell phone to take their medications and check their blood glucose with patients who are just given a cell phone without daily reminders.
The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1c).
The secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived level of diabetes-related stress between the two groups.
Patients in both groups will receive a broad-band enabled cell phone and cell phone service for the duration of the study.
Patients will be randomized into a "cell phone" group (group A) and a "cell phone plus reminder" group (group B).
They will be seen by their provider at least quarterly (or more often as clinically appropriate).
Blood glucose readings will be downloaded from patients' glucometers at every provider visit (at least quarterly).
Group B will receive a daily 15-second video from their provider reminding them to take their medication and to test their blood sugar and an educational "tip-of-the day."
These reminders will be personalized and recorded by their provider.
During the second 6 months, the patients will be followed by their provider at least quarterly.
Improvement in glycemic control will be determined by quarterly measurements of A1c and the mean and standard deviation of blood glucose.
In addition, the number of home blood glucose tests performed on a weekly basis will be compared.
Compliance with medication will be determined by pharmacy refill records and pill counts.
Quality-of-life will be measures using 2 validated instruments at 0, 26 and 52 weeks - the Problem Areas in Diabetes (PAID), which is a diabetes-related quality of life questionnaire and the SF-8, which is a general quality of life questionnaire for people with chronic disease.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
170
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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District of Columbia
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Washington DC, District of Columbia, Estados Unidos, 20307
- Walter Reed Army Hospital Center
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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
18 años a 89 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- age 18 or greater
- A1c greater than 8%
- ability to use a cell phone and glucose meter
- ability to understand English
- on oral therapy and/or insulin
Exclusion Criteria:
- under age 18
- non-English speaking
- females who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method
- A1c less than 8%
- use of glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: A cell phone tips
This group will receive a cell phone and cell phone service for 1 year.
This group will receive a daily video reminders and tips for the first 6 months of the study.
For the second 6 months this group will be seen by their providers at least every 3 months, but the video reminders and and tips will no longer be sent.
The group will be instructed on how to use the cell phone.
The group will be asked to check blood sugar on a schedule determined by their providers.
The group will have blood sugars downloaded from from the glucometer by their providers at every visit and reviewed.
The group will have the A1c measured.
Also it will have this test repeated about every 3 months.
They will continue to have monitored their A1c at 24, 38 and 52 weeks of the study.
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This group will receive a cell phone and cell phone service for 1 year.
This group will receive a daily video reminders and tips for the first 6 months of the study.
For the second 6 months this group will be seen by their providers at least every 3 months, but the video reminders and and tips will no longer be sent.
The group will be instructed on how to use the cell phone.
Otros nombres:
|
|
Comparador activo: B no cell phone tips
This group will receive a cell phone and cell phone service for 1 year.
For the second 6 months this group will be seen by their providers at least every 3 months.
The group will be instructed on how to use the cell phone.The group will be asked to check blood sugar on a schedule determined by their provider.
The groups will have blood sugars downloaded from from the glucometer by their provider at every visit and reviewed.
The group will have A1c measured.
Also it will have this test repeated about every 3 months.
They will continue to have monitored their A1c at 24, 38 and 52 weeks of the study.
|
This group will receive a cell phone and cell phone service for 1 year.
For the second 6 months this group will be seen by their providers at least every 3 months.
The group will be instructed on how to use the cell phone.The group will be asked to check blood sugar on a schedule determined by your provider.
The groups will have blood sugars downloaded from from the glucometer by your provider at every visit and reviewed.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1c).
Periodo de tiempo: week 0, week 12, week 26, week 38, week 52
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week 0, week 12, week 26, week 38, week 52
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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To compare mean blood glucose levels,the number of hypo- and hyperglycemic events,the duration of time spent in target blood glucose range,the perceived level of diabetes-related stress and the perceived effect of diabetes on quality of life.
Periodo de tiempo: week 0, week 12, week 26, week 38, week 52
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week 0, week 12, week 26, week 38, week 52
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Amanda Bell, MD, WRAMC
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 noviembre de 2007
Finalización primaria (Anticipado)
1 de julio de 2010
Finalización del estudio (Anticipado)
1 de octubre de 2010
Fechas de registro del estudio
Enviado por primera vez
24 de febrero de 2010
Primero enviado que cumplió con los criterios de control de calidad
24 de febrero de 2010
Publicado por primera vez (Estimar)
25 de febrero de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
25 de febrero de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
24 de febrero de 2010
Última verificación
1 de junio de 2009
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WU#07-13025
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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