SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients

Not Applicable

Completed

Conditions: Diabetes Mellitus

Interventions: Behavioral: Educational program 6-hour standardized

Registration Number: NCT01087541

Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief Summary: The safety in the diabetic patient refer so much to the accuracy of the treatment and to the handling of the diabetic in security topics. Therefore, is not only an economic question, but a more global concept that means to receive an accurate sanitary attention in line with the available evidences nowadays.

OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is followed of an improvement in the safety of the diabetic patients.

METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA) with a random distribution of the educative intervention to realize on the sanitary professionals (5 intervention/5 control). The intervention is an educative system on adults, brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the diabetics. The group control follows his usual clinical practice on the diabetics.

The participation was voluntary. The centres have been matched, being comparable in population and other characteristics, except the specific intervention; ranging between the 6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected only between 45 until 75 years old as operative age group of the 45 until the 75 years like operative aim.

Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the informatic software for primary care.

Exclusion criteria: serious or terminal illness or patients controlled exclusively by specialists.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6830

Inclusion Criteria

Clinical diagnosis of diabetes
Aged between 45 and 75 years

Exclusion Criteria

No data in informatic system
Severe illness
Controlled only by specialists

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Educational program 6-hour standardized	Behavioural program of education for health professionals. Standardized program of 6 hours for health professionals ( doctors and nurses )

Primary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin A1c at Start	Baseline
Glycosylated Haemoglobin A1c at 6 Months	6 months	Glycohemoglobin A1c at 6 months.

Secondary Outcome Measures

Name	Time	Method
BMI ( Body Mass Index ) at Start	Baseline
BMI at 6 Months	6 months
Blood Pressure ( Systolic / Diastolic )	Baseline
Systolic and Diastolic Blood Pressure	6 months