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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
  Purpose

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.


Condition Intervention
Diabetes
Other: Structured Diabetes Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Structured Diabetes Self-Management Education in Primary Care and Metabolic Control: a Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 138
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01473329     History of Changes
Other Study ID Numbers: 08-464
Study First Received: November 4, 2011
Last Updated: November 18, 2011
Health Authority: Brazil: Comissão nacional de ética em pesquisa (CONEP) MS

Keywords provided by Hospital de Clinicas de Porto Alegre:
diabetes care
diabetes education
diabetes control

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014