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You can access this
clinical trial
if you have
Type 2 Diabetes
and you are
between 18 and 75
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Other: Education

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01456806. The sponsor of the trial is Centro de Endocrinologia Experimental y Aplicada and it is looking for 468 volunteers for the current phase.
Official trial title:
Programme of Diabetes Education in the City of Corrientes (PRODIACOR): Clinical, Metabolic and Economic Outcomes of a Prospective-randomized Trial Based on Different Patient-centered Educational Strategies for People With Type 2 Diabetes