SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients (SEGUDIAB)

March 27, 2011 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Tarragona
      • Reus, Tarragona, Spain, 43202
        • Primary Health Care. Catalan Health Institute. Tarragona-Reus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual clinical health care
Experimental: Intervention
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 )
Other Names:
  • Standardized educational programs
  • Patients safety

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
BMI ( Body Mass Index ) at Start
Time Frame: Baseline
Baseline
BMI at 6 Months
Time Frame: 6 months
6 months
Blood Pressure ( Systolic / Diastolic )
Time Frame: Baseline
Baseline
Systolic and Diastolic Blood Pressure
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Department of Health, Generalitat de Catalunya
Fundación Avedis Donabedian

Investigators

  • Principal Investigator: Juan J Cabré, MD, PhD, Catalan Institute of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Estimate)

March 29, 2011

Last Update Submitted That Met QC Criteria

March 27, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEGUDIAB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Educational program 6-hour standardized

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe