- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00743808
Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes
Improving Hypertension Control in Individuals With Diabetes
Twelve health organizations from around the US were selected to participate in a chart review Hypertension and Diabetes Initiative with the goal of improving blood pressure control in persons with diabetes.
Hypothesis:
A three-phase quality improvement initiative facilitated and monitored through the International Diabetes Center (IDC) will result in improved population-mean systolic blood pressure in the aggregate data pool of patients from all 12 participating sites at geographically distinct health systems.
Descripción general del estudio
Descripción detallada
Phase 1 - Preparation: Each participating site begins to organize itself for the project. Baseline data will be collected and will be used to benchmark where each site is relative to blood pressure control/management of persons with diabetes prior to the implementation of the training programs.
Phase 2 - Implementation: Sites begin to address the gaps they have identified that affect blood pressure outcomes of patients with diabetes. IDC provides two on-site training programs for providers and support staff.
Phase 3 - Follow-up: IDC provides on-going support to each site via individual and collaborative conference calls and resources on the project Web site. Patient and visit data (audit form) will be collected six and 12 months after training. This data will be compared to the site's pre-training data.
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- ICD-9 Code 250 (indicates type 1 or type 2 diabetes)
- ICD- Code 648.0 (indicates pregnancy with type 1 or type 2 diabetes)
- ICD-9 Code 357.2 or 362.0, indicating complications of diabetes.
- A prescription for insulin or oral hypoglycemic agents
- Include those 18-75 years
Exclusion Criteria:
- Attend a dialysis unit (if the nephrologist is primary care manager)
- Have gestational diabetes (ICD-9 Code 648.8)
- Have a terminal illness (e.g., hospice patient)
- Do not have a documented blood pressure within the past year (this is asked on the audit form)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Systolic blood pressure
Periodo de tiempo: 1 year
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Measure changes in action taken related to improving blood pressure management as percent of providers reporting changing (initiating or adjusting) blood pressure medication
Periodo de tiempo: 1 year
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Margaret A Powers, PhD, International Diabetes Center - Park Nicollet Institute
- Investigador principal: Robert M Cuddihy, MD, International Diabetes Center - Park Nicollet Institute
Publicaciones y enlaces útiles
Publicaciones Generales
- Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group, Lachin JM, Genuth S, Cleary P, Davis MD, Nathan DM. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med. 2000 Feb 10;342(6):381-9. doi: 10.1056/NEJM200002103420603. Erratum In: N Engl J Med 2000 May 4;342(18):1376.
- Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197.
- Saaddine JB, Cadwell B, Gregg EW, Engelgau MM, Vinicor F, Imperatore G, Narayan KM. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988-2002. Ann Intern Med. 2006 Apr 4;144(7):465-74. doi: 10.7326/0003-4819-144-7-200604040-00005.
- Adler AI, Stratton IM, Neil HA, Yudkin JS, Matthews DR, Cull CA, Wright AD, Turner RC, Holman RR. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000 Aug 12;321(7258):412-9. doi: 10.1136/bmj.321.7258.412.
- Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). ALLHAT Collaborative Research Group. JAMA. 2000 Apr 19;283(15):1967-75. Erratum In: JAMA 2002 Dec 18;288(23):2976.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- 03527-06-C
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. .