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NCT01728714 Clinical Trial

Better Diabetes Control, Quality - Educate to Achieve Compliance.

Diabetes Type 2 Clinical Trial

— MINERVA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01728714
Other study ID # NIS-CPO-XXX-2012/1
Secondary ID CV/No drug/NIS-C
Status Completed
Phase
First received
Last updated
Start date May 19, 2014
Est. completion date December 5, 2018

Study information
Verified date October 2023
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 227
Est. completion date December 5, 2018
Est. primary completion date December 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Individuals with type 2 diabetes - HbA1c <= 8,5% - Treated with oral antidiabetics for at least 6 months Exclusion Criteria: - Treatment with insulin

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Portugal Research Site Almada
Portugal Research Site Espinho
Portugal Research Site Loures
Portugal Research Site Oeiras
Portugal Research Site Santo Antonio Dos Cavaleiros

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year
Secondary 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. 1 year
Secondary 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. 1 year
Secondary Measure impact on quality of life, perceived by the patient, following 1 year educational programme on diabetes, compared with normal clinical practice. 1 year
Secondary Measure the impact of compliance with treatment on glucose control following 1 year educational programme on diabetes, compared with normal clinical practice. 1 year
Secondary Measure level of satisfaction of the patient with treatment and medical care following 1 year educational programme on diabetes, compared with normal clinical practice. 1 year
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