Overview

Condition diabetes type 2
Sponsor AstraZeneca
Start date May 2014
End date July 2017
Trial size 250 participants
Trial identifier NCT01728714, CV/No drug/NIS-CPO-XXX-2012/1, NIS-CPO-XXX-2012/1

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries Portugal

Study Design

Observational model case control
Time perspective prospective
Arm
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 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

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Individuals with type 2 diabetes - HbA1c <= 8,5% - Treated with oral antidiabetics for at least 6 months Exclusion Criteria: - Treatment with insulin

Additional Information

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
Principal investigator Cláudia Antão
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.