Structured Diabetes Self-Management Education in Primary Care and Metabolic Control
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|ClinicalTrials.gov Identifier: NCT01473329|
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : November 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Other: Structured Diabetes Education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Structured Diabetes Self-Management Education in Primary Care and Metabolic Control: a Randomized Clinical Trial.|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
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
Other: Structured Diabetes Education
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
- HbA1c [ Time Frame: 4, 8 and 12 months ]The primary endpoint was changes in HbA1c at 4, 8 and 12 months.
- Changes in type 2 DM literacy. [ Time Frame: 4, 8 and 12 months ]Additional analyses were done to evaluate changes in type 2 DM literacy.
- Changes in blood pressure (BP) [ Time Frame: 4, 8 and 12 months ]Knowledge of diabetes was estimated by a questionnaire consisting of 22 knowledge scores DM
- Changes in Blood pressure [ Time Frame: 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
- Changes in body mass index (BMI) [ Time Frame: 4,8 and 12 months ]The BMI (weight/height2) was calculated
- Changes in Lipids [ Time Frame: 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).