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

This study is currently recruiting participants.
Verified October 2017 by AstraZeneca
Sponsor:
ClinicalTrials.gov Identifier:
NCT01728714
First Posted: November 20, 2012
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 250
Actual Study Start Date: May 19, 2014
Estimated Study Completion Date: October 31, 2018
Estimated Primary Completion Date: October 31, 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728714


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

Locations
Portugal
Research Site Recruiting
Almada, Portugal
Research Site Completed
Espinho, Portugal
Research Site Completed
Loures, Portugal
Research Site Completed
Oeiras, Portugal
Research Site Completed
Santo Antonio dos Cavaleiros, Portugal
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

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 ( Other Identifier: CTT )
First Submitted: November 14, 2012
First Posted: November 20, 2012
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by AstraZeneca:
Diabetes; compliance

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