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

Diabetes Clinical Trial

Official title:

Structured Diabetes Self-Management Education in Primary Care and Metabolic Control: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473329
• Other study ID #: 08-464
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: November 18, 2011
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Comissão nacional de ética em pesquisa (CONEP) MS
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	The primary endpoint was changes in HbA1c at 4, 8 and 12 months.	4, 8 and 12 months	Yes
Secondary	Changes in type 2 DM literacy.	Additional analyses were done to evaluate changes in type 2 DM literacy.	4, 8 and 12 months	Yes
Secondary	Changes in blood pressure (BP)	Knowledge of diabetes was estimated by a questionnaire consisting of 22 knowledge scores DM	4, 8 and 12 months	Yes
Secondary	Changes in Blood pressure	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	4, 8 and 12 months	Yes
Secondary	Changes in body mass index (BMI)	The BMI (weight/height2) was calculated	4,8 and 12 months	Yes
Secondary	Changes in Lipids	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).	4,8 and 12 months	Yes