SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients

This study has been completed.
Sponsor:
Collaborators:
Departament de Salut Generalitat de Catalunya
Fundación Avedis Donabedian
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01087541
First received: March 15, 2010
Last updated: March 27, 2011
Last verified: March 2011
  Purpose

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 Intervention
Diabetes Mellitus
Behavioral: Educational program 6-hour standardized

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Glycosylated Haemoglobin A1c at Start [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Glycosylated Haemoglobin A1c at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Glycohemoglobin A1c at 6 months.


Secondary Outcome Measures:
  • BMI ( Body Mass Index ) at Start [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • BMI at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood Pressure ( Systolic / Diastolic ) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Systolic and Diastolic Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 6830
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087541

Locations
Spain
Primary Health Care. Catalan Health Institute. Tarragona-Reus
Reus, Tarragona, Spain, 43202
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Departament de Salut Generalitat de Catalunya
Fundación Avedis Donabedian
Investigators
Principal Investigator: Juan J Cabré, MD, PhD Catalan Health Institute
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01087541     History of Changes
Other Study ID Numbers: SEGUDIAB
Study First Received: March 15, 2010
Results First Received: May 31, 2010
Last Updated: March 27, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Jordi Gol i Gurina Foundation:
Patient's Safety
Diabetes mellitus
Public Health for professionals
Safety
Public health

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014