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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087541
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : March 24, 2011
Last Update Posted : March 29, 2011
Sponsor:
Collaborators:
Department of Health, Generalitat de Catalunya
Fundación Avedis Donabedian
Information provided by:
Jordi Gol i Gurina Foundation

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Educational program 6-hour standardized Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6830 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2010
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Glycosylated Haemoglobin A1c at Start [ Time Frame: Baseline ]
  2. Glycosylated Haemoglobin A1c at 6 Months [ Time Frame: 6 months ]
    Glycohemoglobin A1c at 6 months.


Secondary Outcome Measures :
  1. BMI ( Body Mass Index ) at Start [ Time Frame: Baseline ]
  2. BMI at 6 Months [ Time Frame: 6 months ]
  3. Blood Pressure ( Systolic / Diastolic ) [ Time Frame: Baseline ]
  4. Systolic and Diastolic Blood Pressure [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087541


Locations
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Spain
Primary Health Care. Catalan Health Institute. Tarragona-Reus
Reus, Tarragona, Spain, 43202
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Department of Health, Generalitat de Catalunya
Fundación Avedis Donabedian
Investigators
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Principal Investigator: Juan J Cabré, MD, PhD Catalan Institute of Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01087541    
Other Study ID Numbers: SEGUDIAB
First Posted: March 16, 2010    Key Record Dates
Results First Posted: March 24, 2011
Last Update Posted: March 29, 2011
Last Verified: March 2011
Keywords provided by Jordi Gol i Gurina Foundation:
Patient's Safety
Diabetes mellitus
Public Health for professionals
Safety
Public health
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases