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Educative Intervention to Improve Type 2 Diabetes Mellitus Control in Corrientes

NCT01456806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2011-10-21

No results posted yet for this study

Summary

Objective: To evaluate the effect of system interventions (data recording procedures and complete coverage of medications and supplies) with or without physician and/or patient education, upon the psychological, clinical, metabolic and therapeutic indicators and the costs of care of people with type 2 diabetes.

Design: Randomized 2x2 design; sample size was determined considering the change in haemoglobin A1c (primary outcome variable) using a two-sided test at the 5% level of significance, and 80% power using a paired t-test. Sample size was increased by 25% to account for non-independence and patient drop-out.

Setting: Primary care level in the city of Corrientes, Argentina with involvement of all three Argentinean health subsectors (public health, social security and the private, prepaid system).

Participants: 36 general practitioners and 468 adults (62-71% women, mean age 62 years) with type 2 diabetes. Patients of the participating physicians (nine in each group), were randomly selected and assigned to one of four groups (117 patients each): control, provider education, patient education, and provider/patient education.

Intervention: Structured group education programmes were delivered to provider and/or people with type 2 diabetes by trained professionals; identical system interventions were applied to all four groups.

Main outcome measures: Body mass index, blood pressure, fasting glucose, haemoglobin A1c levels, lipid profile, drug consumption, resource use, and patient well being (WHO-5 questionnaire and Lowe score), at baseline and up to 42 months at every 6 months intervals.

Conditions

Interventions

OTHER

Education

Structured group education programmes were delivered to provider and/or people with type 2 diabetes by trained professionals; identical system interventions were applied to all four groups.

Sponsors & Collaborators

  • National Council of Scientific and Technical Research, Argentina

    collaborator OTHER_GOV

  • Centro de Endocrinologia Experimental y Aplicada

    lead OTHER

Principal Investigators

  • Juan J Gagliardino, MD · CENEXA (UNLP-CONICET La Plata)

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-03-31
Completion
2010-07-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456806 on ClinicalTrials.gov