Structured Diabetes Self-Management Education in Primary Care and Metabolic Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01473329
First received: November 4, 2011
Last updated: November 18, 2011
Last verified: November 2011

November 4, 2011
November 18, 2011
January 2009
July 2011   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 4, 8 and 12 months ] [ Designated as safety issue: Yes ]
The primary endpoint was changes in HbA1c at 4, 8 and 12 months.
Same as current
Complete list of historical versions of study NCT01473329 on ClinicalTrials.gov Archive Site
  • Changes in type 2 DM literacy. [ Time Frame: 4, 8 and 12 months ] [ Designated as safety issue: Yes ]
    Additional analyses were done to evaluate changes in type 2 DM literacy.
  • Changes in blood pressure (BP) [ Time Frame: 4, 8 and 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The BMI (weight/height2) was calculated
  • Changes in Lipids [ Time Frame: 4,8 and 12 months ] [ Designated as safety issue: Yes ]
    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).
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
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
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
Intervention: Other: Structured Diabetes Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01473329
08-464
Yes
Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Not Provided
Not Provided
Hospital de Clinicas de Porto Alegre
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP