Educative Intervention to Improve Type 2 Diabetes Mellitus Control in Corrientes
PRODIACOR
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
1 other identifier
interventional
468
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Dec 2006
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 21, 2011
CompletedOctober 21, 2011
October 1, 2011
3 months
October 19, 2011
October 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
42 months
Secondary Outcomes (1)
Quality of Care Indicators
42 months
Study Arms (4)
Patients and provider non educated
NO INTERVENTIONIn this arm neither the patients nor the providers have attended the groupal education courses
Provider educated
ACTIVE COMPARATORProvider attend the interactive group education, while patients do not.
Patients Educated
ACTIVE COMPARATORPatients attend the interactive group education, while providers do not.
Providers/Patients Educated
ACTIVE COMPARATORProvider and Patients both attend the interactive group education.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults Patients with type 2 diabetes
- Being regularly attended at the doctors office during at least one year
You may not qualify if:
- Newly diagnosed type 2 diabetes
- Advanced stage of chronics complications (End-stage-kidney disease)
- Heart Failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CENEXA (UNLP-CONICET La PLata)
La Plata, Buenos Aires, 1900, Argentina
Related Publications (2)
Gagliardino JJ, Lapertosa S, Villagra M, Caporale JE, Oliver P, Gonzalez C, Siri F, Clark Ch Jr; PRODIACOR. PRODIACOR: a patient-centered treatment program for type 2 diabetes and associated cardiovascular risk factors in the city of Corrientes, Argentina: study design and baseline data. Contemp Clin Trials. 2007 Jul;28(4):548-56. doi: 10.1016/j.cct.2007.01.004. Epub 2007 Jan 12.
PMID: 17331807BACKGROUNDGagliardino JJ, Lapertosa S, Pfirter G, Villagra M, Caporale JE, Gonzalez CD, Elgart J, Gonzalez L, Cernadas C, Rucci E, Clark C Jr; PRODIACOR. Clinical, metabolic and psychological outcomes and treatment costs of a prospective randomized trial based on different educational strategies to improve diabetes care (PRODIACOR). Diabet Med. 2013 Sep;30(9):1102-11. doi: 10.1111/dme.12230. Epub 2013 Jun 7.
PMID: 23668772DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Juan J Gagliardino, MD
CENEXA (UNLP-CONICET La Plata)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2011
First Posted
October 21, 2011
Study Start
December 1, 2006
Primary Completion
March 1, 2007
Study Completion
July 1, 2010
Last Updated
October 21, 2011
Record last verified: 2011-10