Structured Diabetes Self-Management Education in Primary Care and Metabolic Control
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Education is the mainstay of treatment of diabetes mellitus (DM), since it is through her
      that patients are trained to perform the management of your disease. There is a wide range of
      educational interventions tested in patients with DM, not having been defined so far a
      universal template that can be standardized and recognized as effective for all individuals
      with the disease. The present study aims to evaluate the effect of a group based structured
      education program, applied by a primary care generalist nurse, on metabolic control of type 2
      diabetes mellitus (DM2) patients attending a primary care unit.
    

Detailed description: 
      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.
    

Intervention name(s): Structured Diabetes Education
Intervention type(s): Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes care; diabetes education; diabetes control