Structured Diabetes Self-Management Education in Primary Care and Metabolic Control
NCT ID: NCT01473329
Last Updated: 2011-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2009-01-31
2011-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* with DM2 (ref ADA), and with A1c \>7%,
* regularly attending a primary care unit in the previous 6 months
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Other Identifiers
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08-464
Identifier Type: -
Identifier Source: org_study_id