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Better Diabetes Control, Quality - Educate to Achieve Compliance (MINERVA)

This study is not yet open for participant recruitment.
Verified November 2012 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01728714
First received: November 14, 2012
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

Prospective study to evaluate the impact of an educational programme about diabetes, comparing to normal clinical practice, on treatment compliance and disease control of people with type 2 diabetes followed in the primary care units in Portugal.


Condition
Diabetes Type 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study to Evaluate the Impact of an Educational Programme About Diabetes, Comparing to Normal Clinical Practice, on Treatment Compliance and Disease Control of People With Type 2 Diabetes Followed in the Primary Care Units in Portugal.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment after 1 year educational programme on diabetes, compared with normal clinical practice. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with diet and physical exercise after 1 year educational programme on diabetes, compared with normal clinical practice. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment with oral antidiabetics;after 1 year educational programme on diabetes, compared with normal clinical practice. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measure impact on quality of life, perceived by the patient, following 1 year educational programme on diabetes, compared with normal clinical practice. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measure the impact of compliance with treatment on glucose control following 1 year educational programme on diabetes, compared with normal clinical practice. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measure level of satisfaction of the patient with treatment and medical care following 1 year educational programme on diabetes, compared with normal clinical practice. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adults over 18 years old, with type 2 diabetes, HbA1c <= 8,5%, treated with oral antidiabetics at least for 6 months submitted to an educational programme during 1 year
2
Adults over 18 years old, with type 2 diabetes, HbA1c <= 8,5%, treated with oral antidiabetics at least for 6 months followed according to normal clinical practice during 1 year

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care setting patients

Criteria

Inclusion Criteria:

  • Individuals with type 2 diabetes
  • HbA1c <= 8,5%
  • Treated with oral antidiabetics for at least 6 months

Exclusion Criteria:

- Treatment with insulin

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728714

Contacts
Contact: AstraZeneca Portugal Clinical Study Information 00351214345720 sandra.barbosa@astrazeneca.com
Contact: Ana Rita Lima anarita.lima@astrazeneca.com

Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01728714     History of Changes
Other Study ID Numbers: NIS-CPO-XXX-2012/1
Study First Received: November 14, 2012
Last Updated: November 30, 2012
Health Authority: Portugal: National Data Protection Committee

Keywords provided by AstraZeneca:
Diabetes; compliance

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

ClinicalTrials.gov processed this record on May 19, 2013