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SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients

F

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Behavioral: Educational program 6-hour standardized

Study type

Interventional

Funder types

Other

Identifiers

NCT01087541
SEGUDIAB

Details and patient eligibility

About

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.

Enrollment

6,830 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

6,830 participants in 2 patient groups

Control
No Intervention group
Description:
Usual clinical health care
Intervention
Experimental group
Description:
Behavioural program of education for health professionals. Standardized program of 6 hours for health professionals ( doctors and nurses )
Treatment:
Behavioral: Educational program 6-hour standardized

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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