Educative Intervention to Improve Type 2 Diabetes Mellitus Control in Corrientes (PRODIACOR)
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ClinicalTrials.gov Identifier: NCT01456806 |
Recruitment Status :
Completed
First Posted : October 21, 2011
Last Update Posted : October 21, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Other: Education | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 468 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Official 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 |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
No Intervention: Patients and provider non educated
In this arm neither the patients nor the providers have attended the groupal education courses
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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.
Other Name: Diabetes Education |
Active Comparator: Provider educated
Provider attend the interactive group education, while patients do not.
|
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.
Other Name: Diabetes Education |
Active Comparator: Patients Educated
Patients attend the interactive group education, while providers do not.
|
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.
Other Name: Diabetes Education |
Active Comparator: Providers/Patients Educated
Provider and Patients both attend the interactive group education.
|
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.
Other Name: Diabetes Education |
- HbA1c [ Time Frame: 42 months ]
- Quality of Care Indicators [ Time Frame: 42 months ]Body mass index, blood pressure, fasting glucose, lipid profile, drug consumption, resource use, and patient well being (WHO-5 questionnaire and Lowe score)

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults Patients with type 2 diabetes
- Being regularly attended at the doctors office during at least one year
Exclusion Criteria:
- Newly diagnosed type 2 diabetes
- Advanced stage of chronics complications (End-stage-kidney disease)
- Heart Failure.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456806
Argentina | |
CENEXA (UNLP-CONICET La PLata) | |
La Plata, Buenos Aires, Argentina, 1900 |
Study Director: | Juan J Gagliardino, MD | CENEXA (UNLP-CONICET La Plata) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Centro de Endocrinologia Experimental y Aplicada |
ClinicalTrials.gov Identifier: | NCT01456806 |
Other Study ID Numbers: |
1374/2006 (ACC) |
First Posted: | October 21, 2011 Key Record Dates |
Last Update Posted: | October 21, 2011 |
Last Verified: | October 2011 |
T2DM Cardiovascular risk factors Metabolic control |
Well-being Cost Cost-consequence |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |