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Completed

NCT Number: NCT01087541

SEGUDIAB Study: Evaluation of Safety in the 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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Health Care. Catalan Health Institute. Tarragona-Reus

Reus, Tarragona, 43202, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational program 6-hour standardized

Behavioral

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

Other names: Standardized educational programs, Patients safety

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Department of Health, Generalitat de Catalunya
  • Fundación Avedis Donabedian

Registry information

Official study title

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

Acronym: SEGUDIAB

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Mar 16, 2010
Registry last updated
Mar 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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