Educative Intervention to Improve Type 2 Diabetes Mellitus Control in Corrientes (PRODIACOR)

This study has been completed.
Sponsor:
Collaborator:
National Council of Scientific and Technical Research, Argentina
Information provided by (Responsible Party):
Centro de Endocrinologia Experimental y Aplicada
ClinicalTrials.gov Identifier:
NCT01456806
First received: October 19, 2011
Last updated: October 20, 2011
Last verified: October 2011
  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.


Condition Intervention
Type 2 Diabetes
Other: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centro de Endocrinologia Experimental y Aplicada:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Care Indicators [ Time Frame: 42 months ] [ Designated as safety issue: No ]
    Body mass index, blood pressure, fasting glucose, lipid profile, drug consumption, resource use, and patient well being (WHO-5 questionnaire and Lowe score)


Enrollment: 468
Study Start Date: December 2006
Study Completion Date: July 2010
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Patients and provider non educated
In this arm neither the patients nor the providers have attended the groupal education courses
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456806

Locations
Argentina
CENEXA (UNLP-CONICET La PLata)
La Plata, Buenos Aires, Argentina, 1900
Sponsors and Collaborators
Centro de Endocrinologia Experimental y Aplicada
National Council of Scientific and Technical Research, Argentina
Investigators
Study Director: Juan J Gagliardino, MD CENEXA (UNLP-CONICET La Plata)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centro de Endocrinologia Experimental y Aplicada
ClinicalTrials.gov Identifier: NCT01456806     History of Changes
Other Study ID Numbers: 1374/2006 (ACC)
Study First Received: October 19, 2011
Last Updated: October 20, 2011
Health Authority: Argentina: Ministry of Health

Keywords provided by Centro de Endocrinologia Experimental y Aplicada:
T2DM
Cardiovascular risk factors
Metabolic control
Well-being
Cost
Cost-consequence

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014