Clinical trial NCT01728714: Better Diabetes Control, Quality - Educate to Achieve Compliance.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Type 2
Keywords: Diabetes; compliance
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care setting patients

Brief 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

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 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

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.
timeFrame: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: Measure impact on quality of life, perceived by the patient, following 1 year educational programme on diabetes, compared with normal clinical practice.
timeFrame: 1 year
measure: Measure the impact of compliance with treatment on glucose control following 1 year educational programme on diabetes, compared with normal clinical practice.
timeFrame: 1 year
measure: Measure level of satisfaction of the patient with treatment and medical care following 1 year educational programme on diabetes, compared with normal clinical practice.
timeFrame: 1 year
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Research Site
city: Espinho
country: Portugal
facility: Research Site
city: Loures
country: Portugal
facility: Research Site
city: Oeiras
country: Portugal
facility: Research Site
city: Santo Antonio Dos Cavaleiros
country: Portugal
facility: Research Site
Study officials:
affiliation: Research Site 01
name: Cláudia Antão
role: PRINCIPAL_INVESTIGATOR
affiliation: Research site 02
name: Pedro Carriço
role: PRINCIPAL_INVESTIGATOR
affiliation: Research site 03
name: Carla Gouveia
role: PRINCIPAL_INVESTIGATOR
affiliation: Research site 04
name: Jorge Vinagre
role: PRINCIPAL_INVESTIGATOR
References: