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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01728714
First received: November 14, 2012
Last updated: July 15, 2016
Last verified: July 2016

November 14, 2012
July 15, 2016
May 2014
July 2017   (final data collection date for primary outcome measure)
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 ]
Evaluate the impact of applying, for 1 year, an educational programme on people with type 2 diabetes treated with oral antidiabetics, compared with normal clinical practice, on compliance with treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01728714 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Assess the impact of a 1 year educational programme applied to people with type 2 diabetes treated with oral antidiabetics, compared with normal clinical practice, on compliance with diet and physical exercise; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • on compliance with treatment with oral antidiabetics; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • on quality of life, perceived by the patient, and level of satisfaction of the patient with treatment and medical care [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate the impact of compliance with treatment on glucose control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Better Diabetes Control, Quality - Educate to Achieve Compliance
Prospective Study to Evaluate 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 Primary Care Units in Portugal
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.
Prospective study to evaluate the impact of an educational programme about diabetes focusing on treatment compliance, exercise and nutrition, 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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
primary care setting patients
Diabetes Type 2
Not Provided
  • Adults over 18 years old
    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
  • Adults with HbA1c <= 8,5%
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
July 2017
July 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

- Treatment with insulin

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01728714
NIS-CPO-XXX-2012/1, CV/No drug/NIS-CPO-XXX-2012/1
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Cláudia Antão Research Site 01
Principal Investigator: Pedro Carriço Research site 02
Principal Investigator: Carla Gouveia Research site 03
Principal Investigator: Jorge Vinagre Research site 04
AstraZeneca
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP