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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01728714
First received: November 14, 2012
Last updated: June 16, 2014
Last verified: June 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 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.

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: May 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Sandra Barbosa 00351214345720 sandra.barbosa@astrazeneca.com
Contact: Ana Rita Lima anarita.lima@astrazeneca.com

Locations
Portugal
Research Site Not yet recruiting
Espinho, Portugal
Principal Investigator: Jorge Vinagre         
Research Site Not yet recruiting
Loures, Portugal
Principal Investigator: Carla Gouveia         
Research Site Recruiting
Santo Antonio dos Cavaleiros, Portugal
Principal Investigator: Claudia Antão         
Research Site Recruiting
Santo Antonio dos Cavaleiros, Portugal
Principal Investigator: Pedro Carriço         
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01728714     History of Changes
Other Study ID Numbers: NIS-CPO-XXX-2012/1, CV/No drug/NIS-CPO-XXX-2012/1
Study First Received: November 14, 2012
Last Updated: June 16, 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 July 31, 2014