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

This study is not yet open for participant recruitment.
Verified January 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01728714
First received: November 14, 2012
Last updated: January 8, 2014
Last verified: January 2014
  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:


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 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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: January 8, 2014
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 April 17, 2014