SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients

Study Overview
=================
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.

Official Title
-----------------
SEGUDIAB Study: Safety in Diabetic Patients. Evaluation of an Educational Program for the Professionals to Improve the Safety in Diabetic Patients

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Educational program 6-hour standardized


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual clinical health care | |
| Experimental: Intervention<br>Behavioural program of education for health professionals. Standardized program of 6 hours for health professionals ( doctors and nurses ) | Behavioral: Educational program 6-hour standardized<br>* 6-hour standardized program for adults ( doctors and nurses )<br>* Other names: Patients safety;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin A1c at Start |  | Baseline | 
| Glycosylated Haemoglobin A1c at 6 Months | Glycohemoglobin A1c at 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient's Safety, Diabetes mellitus, Public Health for professionals, Safety, Public health