Clinical trial NCT01473329: Structured Diabetes Self-Management Education in Primary Care and Metabolic Control
Official title: Structured Diabetes Self-Management Education in Primary Care and Metabolic Control: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes care
diabetes education
diabetes control
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 4, 8 and 12 months
Secondary outcomes:
measure: Changes in type 2 DM literacy.
timeFrame: 4, 8 and 12 months
measure: Changes in blood pressure (BP)
timeFrame: 4, 8 and 12 months
measure: Changes in Blood pressure
timeFrame: 4, 8 and 12 months
measure: Changes in body mass index (BMI)
timeFrame: 4,8 and 12 months
measure: Changes in Lipids
timeFrame: 4,8 and 12 months
Other outcomes:
Locations:
Study officials:
References: