SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||SEGUDIAB Study: Safety in Diabetic Patients. Evaluation of an Educational Program for the Professionals to Improve the Safety in Diabetic Patients|
- Glycosylated Haemoglobin A1c at Start [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Glycosylated Haemoglobin A1c at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Glycohemoglobin A1c at 6 months.
- BMI ( Body Mass Index ) at Start [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- BMI at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Blood Pressure ( Systolic / Diastolic ) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Systolic and Diastolic Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
No Intervention: Control
Usual clinical health care
Behavioural program of education for health professionals. Standardized program of 6 hours for health professionals ( doctors and nurses )
Behavioral: Educational program 6-hour standardized
6-hour standardized program for adults ( doctors and nurses )
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087541
|Primary Health Care. Catalan Health Institute. Tarragona-Reus|
|Reus, Tarragona, Spain, 43202|
|Principal Investigator:||Juan J Cabré, MD, PhD||Catalan Institute of Health|