Clinical trial NCT01087541: SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients
Official title: SEGUDIAB Study: Safety in Diabetic Patients. Evaluation of an Educational Program for the Professionals to Improve the Safety in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Patient's Safety
Diabetes mellitus
Public Health for professionals
Safety
Public health
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
name: Fundación Avedis Donabedian
First posted: 2010-03-16
Enrollment: 6830
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Glycosylated Haemoglobin A1c at Start
timeFrame: Baseline
measure: Glycosylated Haemoglobin A1c at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: BMI ( Body Mass Index ) at Start
timeFrame: Baseline
measure: BMI at 6 Months
timeFrame: 6 months
measure: Blood Pressure ( Systolic / Diastolic )
timeFrame: Baseline
measure: Systolic and Diastolic Blood Pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Primary Health Care. Catalan Health Institute. Tarragona-Reus
state: Tarragona
Study officials:
affiliation: Catalan Institute of Health
name: Juan J Cabré, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabre JJ, Ripoll M, Hernandez JM, Basora J, Bejarano F, Arija V. Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. BMC Public Health. 2011 Jun 5;11:430. doi: 10.1186/1471-2458-11-430.