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

NCT01473329 | Completed DMC

• 1 other identifier: 08-464
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes

Keywords

diabetes care; diabetes education; diabetes control

Outcome Measures

Primary Outcomes (1)

• HbA1c

  The primary endpoint was changes in HbA1c at 4, 8 and 12 months.

  4, 8 and 12 months

Secondary Outcomes (5)

• Changes in type 2 DM literacy.

  4, 8 and 12 months

• Changes in blood pressure (BP)

  4, 8 and 12 months

• Changes in Blood pressure

  4, 8 and 12 months

• Changes in body mass index (BMI)

  4,8 and 12 months

• Changes in Lipids

  4,8 and 12 months

Study Arms (1)

Structured Diabetes education

EXPERIMENTAL

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

Interventions

Structured Diabetes Education OTHER

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

Structured Diabetes education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 17, 2011
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 21, 2011

Record last verified: 2011-11