- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00288132
The Diabetes TeleCare Study (DTC)
Bridging Barriers to Diabetes Care With Telemedicine: The Diabetes TeleCare Study (DTC)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
According to recent 2002 estimates, the yearly cost of diabetes was approximately $132 billion. The burden of diabetes is considerable, particularly for ethnically diverse populations. Disease management programs that focus on self-management education have been effective in improving metabolic control. Accordingly, the American Diabetes Association clinical care guidelines stress the importance of metabolic control to prevent complications and improve quality of life for persons with this disease. Unfortunately, these advances have not resulted in widespread acceptance into clinical practice. Therefore, we propose translational research to evaluate telemedicine technology using interactive video conferencing (Diabetes TeleCare) as a novel means to increase the availability of health professionals in rural communities for the effective delivery of a diabetes self-management education program and as a means to provide retinal screenings in the primary care setting. Our aims are to 1) develop and implement a 12-month intervention, Diabetes TeleCare to improve adherence to diabetes clinical care guidelines and improve diabetes control in two community health centers located in ethnically diverse, rural and medically underserved communities, 2) conduct a one-year randomized clinical trial (RCT) of 200 patients to formally evaluate the effectiveness of Diabetes TeleCare compared to Usual Care in a sample with >60% African-Americans, and 3) determine the cost-effectiveness and satisfaction of Diabetes TeleCare compared to Usual Care. Participants are recruited from two community health centers in rural South Carolina and randomized according to a patient randomization schedule. Diabetes TeleCare (a structured curriculum) is delivered by a team consisting of a registered nurse/certified diabetes educator (RN-CDE) and an experienced registered dietitian, with support by other health professionals who are linked by interactive video conferencing to participants (single and group) in rural health centers at distant locations. The primary outcomes are measures of metabolic control (A1c, lipids), blood pressure, and use of the telemedicine-facilitated retinal screening capacity. Secondary outcomes include satisfaction, quality of life, health beliefs, and knowledge. The economic analysis will include an assessment of resource utilization, cost, and health utilities. In addition, incremental reductions in costs per A1c and the estimated lifetime cost-utility of Diabetes TeleCare compared to usual care will be determined. Telemedicine may be an effective alternative to traditional health care delivery systems resulting in improved diabetes education and control.
The intervention goal was to achieve an A1c <7%, with secondary goals of 10% weight loss and increasing exercise to at least 30 minutes a day, 5 days a week. Participants attend 13 sessions, 2 in the first month (1 group, 1 individual), monthly thereafter (9 group, 2 individual). Three group sessions were conducted in-person, all others were conducted via telemedicine. The self-management education team consisted of an RN/CDE and an RD. Sessions were conducted remotely, with a trained facilitator (LPN) at the clinic site. Participants were given a notebook and new material was added at each session. Completion of self-monitoring logs, including blood sugar, diet and physical activity, was assigned daily followed by less frequently based on progress towards intervention goals.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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South Carolina
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Bennettsville, South Carolina, Estados Unidos, 29512
- CareSouth Bennettsville
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All participants must have a confirmed physician diagnosis of type 2 diabetes supported by American Diabetes Association diagnostic criteria for blood glucose levels or
- Current use of oral hypoglycemic agents or insulin as confirmed by brief medical record review.
- All adults (> 21 years of age) who have a A1c value > 7.0 will be eligible.
Exclusion Criteria:
Exclusion criteria applies to individuals with limitations that could limit safe participation in the study,
- such as metastatic cancer,
- multiple or recent (within six months) myocardial infarction (MI) or stroke,
- dialysis for end stage renal disease,
- severe psychiatric disease or dementia, or
- inability to walk without an assistive device.
- We will also exclude women who are pregnant at the time of study recruitment (based on self report only) because of the unique needs related to diabetes self-management during pregnancy.
- We will, however, retain women in the study should they become pregnant during the course of the project.
- Individuals will be excluded if they plan to move out of the area.
- Additional exclusions may include inability to complete baseline tasks to the satisfaction of the lead interventionist or other more subjective assessment suggesting inability or unwillingness to adhere reasonably to the intervention based on interventionist review.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervención
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A 12-month diabetes self-management intervention delivered via telemedicine, with opportunity to receive telemedicine-based screening eye exam, was conducted.
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Comparador activo: Cuidado usual
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Upon randomization, received one 15-minute diabetes self-management individual session, using American Diabetes Association materials.
Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Hemoglobin A1c
Periodo de tiempo: 6 mths, 12 mths, 24 mths
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6 mths, 12 mths, 24 mths
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Blood pressure
Periodo de tiempo: 6 mths, 12 mths, 24 mths
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6 mths, 12 mths, 24 mths
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LDL Cholesterol
Periodo de tiempo: 6 mths, 12 mths, 24 mths
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6 mths, 12 mths, 24 mths
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Cost effectiveness and cost utility
Periodo de tiempo: 6 mths, 12 mths
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6 mths, 12 mths
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Retinal examination rates
Periodo de tiempo: 12 months
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12 months
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Weight
Periodo de tiempo: 6 mths, 12 mths, 24 mths
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6 mths, 12 mths, 24 mths
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Waist Circumference
Periodo de tiempo: 6 mths, 12 mths, 24 mths
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6 mths, 12 mths, 24 mths
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Richard M Davis, MD, University of South Carolina
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R18 67312 (completed)
- R18DK067312 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA 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. .
Ensayos clínicos sobre Diabetes Mellitus, Tipo 2
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AstraZenecaReclutamiento
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Daewoong Pharmaceutical Co. LTD.Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)
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University of ZambiaUniversity Teaching Hospital, Lusaka, ZambiaAún no reclutandoDiabetes Mellitus Tipo 2 Sin Complicaciones
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Zhongda HospitalReclutamientoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Newsoara Biopharma Co., Ltd.ReclutamientoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
Shanghai Golden Leaf MedTec Co. LtdActivo, no reclutandoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Haisco Pharmaceutical Group Co., Ltd.TerminadoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
PegBio Co., Ltd.TerminadoDiabetes mellitus tipo 2 (DM2)Porcelana
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Oramed, Ltd.IntegriumTerminadoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos
Ensayos clínicos sobre Usual Care
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Aarogyam UKNMP Medical Research Institute; Croydon Ayurveda Centre; Active Naturals Limited; AVP Research FoundationActivo, no reclutandoDesorden psiquiátricoIndia
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University of Texas at AustinDesconocidoEsclerosis múltipleEstados Unidos
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NYU Langone HealthNational Institute on Aging (NIA)Activo, no reclutandoDemenciaEstados Unidos
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Icahn School of Medicine at Mount SinaiUniversity of WashingtonReclutamientoCáncer colonrectal | Cáncer de vejigaEstados Unidos
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Assistance Publique Hopitaux De MarseilleReclutamiento
-
The University of Texas Health Science Center,...Aún no reclutandoNutrición en el embarazo de alto riesgoEstados Unidos
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Silke Wiegand-Grefe, Prof. Dr.Charite University, Berlin, Germany; Hannover Medical School; University Hospital... y otros colaboradoresActivo, no reclutandoEnfermedades rarasAlemania
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Elizabeth Glaser Pediatric AIDS FoundationUnited States Agency for International Development (USAID); Ministry of Health...TerminadoInfecciones por VIHSuazilandia
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University Health Network, TorontoReclutamientoLinfoma | Trastornos linfoproliferativos | Etapa I del cáncer de mama | Cáncer de mama en estadio II | Cáncer colorrectal en estadio II | Cáncer colorrectal en estadio III | Etapa III del cáncer de mama | Cáncer colorrectal Etapa I | Cáncer de cabeza y cuello estadio III | Cáncer de mama, estadio 0 | Cáncer... y otras condicionesCanadá
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KintoAlzheimer's AssociationTerminadoDemencia | Enfermedad de Alzheimer | Enfermedad de cuerpos de Lewy | Demencia frontotemporal | Demencia vascular | Demencia mixtaEstados Unidos