- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01473329
Structured Diabetes Self-Management Education in Primary Care and Metabolic Control
Structured Diabetes Self-Management Education in Primary Care and Metabolic Control: a Randomized Clinical Trial.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Design: This was a single-center, parallel-group, randomized study Setting: One Primary Care Unit named Santa Cecília/Hospital de Clínicas de Porto Alegre Basic Unit of health, in Porto Alegre, Brazil.
Patients: Adult subjects (more than 18 years-old) up to the age of 80 years, with Type 2 diabetes, and with A1c >7%, regularly attending the primary care unit in the previous 6 months before the trial.
Exclusion criteria were: history of active infection (eg. osteomyelitis, pulmonary tuberculosis, AIDS), chronic corticosteroids use, unstable angina or myocardial infarction in the last 3 months, advanced renal disease require dialysis, heart failure (New York Heart Association class III and IV), cirrhosis, alcohol or illicit drug use, dementia, actual pregnancy or lactation, current cancer or any disease that might affect survival in the next 5 years.
Intervention: The intervention group (I) attended a five-week education course and reinforcement meetings every 4 months, for one year. The control group (C) received usual medical care.
Measures: Clinical (age, gender, ethnicity, history of hypertension and BP levels, smoking and physical activity), anthropometrical (weight, height, and waist circumference) and laboratorial data (fasting glucose levels, A1c, and lipid profile) The Diabetes knowledge was estimated by a questionnaire composed by 22 questions addressing the information discussed in the meetings and will be referred as type 2 DM knowledge score. This measures were done at 0, 4, 8 and 12 months End-points: The primary endpoint was changes in HbA1c at 4, 8 and 12 months. Additional analyses were done to evaluate changes in type 2 DM literacy, blood pressure (BP), body mass index (BMI) and lipids.
Statistical Analysis: Student t and chi-square test were used to compare baseline continuous and categorical variables, respectively. Variables with non-normal distribution were log transformed. Global linear model (GLM) for repeated measurements, with Bonferroni post-hoc test, was used to analyze changes in the outcomes during the trial. HbA1c values after the interventions were adjusted to baseline A1c and dosage of insulin at 12 months by ANCOVA. All patients with at least one A1c measurement available after randomization were included in the analyses, regardless if they attended all meetings of the education course or not (intention to treat analysis). A P value <0.05 (two-tailed) was considered significant.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- adult subjects (more than 18 years-old) up to the age of 80 years,
- with DM2 (ref ADA), and with A1c >7%,
- regularly attending a primary care unit in the previous 6 months
Exclusion Criteria:
- history of active infection (eg. osteomyelitis, pulmonary tuberculosis, AIDS),
- chronic corticosteroids use,
- unstable angina or myocardial infarction in the last 3 months,
- advanced renal disease require dialysis,
- heart failure (New York Heart Association class III and IV),
- cirrhosis,
- alcohol or illicit drug use,
- dementia,
- actual pregnancy or lactation,
- current cancer or any disease that might affect survival in the next 5 years.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Structured Diabetes education
The intervention group received a structured DSME course.
The course was composed by weekly 2 hour meetings for five weeks total hours group of 10 patient and reinforcement meetings every 4 months, for one year
|
The intervention group received a structured DSME course adapted from 15.
The course was composed by weekly 2 hour meetings for five weeks total hours group of 10 patient and reinforcement meetings every 4 months, for one year
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HbA1c
Periodo de tiempo: 4, 8 and 12 months
|
The primary endpoint was changes in HbA1c at 4, 8 and 12 months.
|
4, 8 and 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in type 2 DM literacy.
Periodo de tiempo: 4, 8 and 12 months
|
Additional analyses were done to evaluate changes in type 2 DM literacy.
|
4, 8 and 12 months
|
Changes in blood pressure (BP)
Periodo de tiempo: 4, 8 and 12 months
|
Knowledge of diabetes was estimated by a questionnaire consisting of 22 knowledge scores DM
|
4, 8 and 12 months
|
Changes in Blood pressure
Periodo de tiempo: 4, 8 and 12 months
|
The BP was measured twice with a digital sphygmomanometer (OMROM) with the patient in a sitting position, after a 5-min rest and with 1-min interval between measurements.
The value registered was the medium between two measures
|
4, 8 and 12 months
|
Changes in body mass index (BMI)
Periodo de tiempo: 4,8 and 12 months
|
The BMI (weight/height2) was calculated
|
4,8 and 12 months
|
Changes in Lipids
Periodo de tiempo: 4,8 and 12 months
|
The measure of fasting plasma total cholesterol, HDL and triglycerides were by enzymatic colorimetric method 20.
The Low-density lipoprotein cholesterol (LDL) was calculated by the formula of Friedwald equation (LDL = total cholesterol - HDL + Triglycerides/5).
|
4,8 and 12 months
|
Colaboradores e Investigadores
Patrocinador
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
- 08-464
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 Structured Diabetes Education
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Medical College of WisconsinActivo, no reclutando
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University of SheffieldUniversity of Liverpool; University of Manchester; University of MelbourneActivo, no reclutandoDesarrollo del lenguajeReino Unido
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Stanford UniversityNational Institute on Aging (NIA)ReclutamientoLa inactividad físicaEstados Unidos
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Duke UniversityTerminadoTratamiento y prevención de la anemia después de la administración de la barra nutricional GudnessIndia
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University of Texas Southwestern Medical CenterAmerican Heart AssociationAún no reclutandoInsuficiencia Cardíaca Sistólica
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Washington University School of MedicineTerminadoCáncer | Trastorno geriátrico | Caída del pacienteEstados Unidos
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University of AlbertaGlenrose Foundation; Scoliosis Research Society; SickKids Foundation CIHR Institute...Terminado
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University of MichiganAgency for Healthcare Research and Quality (AHRQ)TerminadoDiabetes tipo 2Estados Unidos