SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients

NCT ID: NCT01087541

Last Updated: 2011-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6830 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control

Usual clinical health care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Behavioural program of education for health professionals. Standardized program of 6 hours for health professionals ( doctors and nurses )

Group Type: EXPERIMENTAL

Educational program 6-hour standardized

Intervention Type: BEHAVIORAL

6-hour standardized program for adults ( doctors and nurses )

Interventions

Educational program 6-hour standardized

6-hour standardized program for adults ( doctors and nurses )

Intervention Type: BEHAVIORAL

Other Intervention Names

Standardized educational programs; Patients safety

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health, Generalitat de Catalunya

OTHER_GOV

Sponsor Role: collaborator

Fundación Avedis Donabedian

UNKNOWN

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Jordi Gol i Gurina Foundation

Principal Investigators

Juan J Cabré, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catalan Institute of Health

Locations

Primary Health Care. Catalan Health Institute. Tarragona-Reus

Reus, Tarragona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 21639938 (View on PubMed)

Other Identifiers

SEGUDIAB

Identifier Type: -

Identifier Source: org_study_id