NCT01087541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,830

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 24, 2011

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

11 months

First QC Date

March 15, 2010

Results QC Date

May 31, 2010

Last Update Submit

March 27, 2011

Conditions

Diabetes Mellitus

Keywords

Patient's SafetyDiabetes mellitusPublic Health for professionalsSafetyPublic health

Outcome Measures

Primary Outcomes (2)

  • Glycosylated Haemoglobin A1c at Start

    Baseline

  • Glycosylated Haemoglobin A1c at 6 Months

    Glycohemoglobin A1c at 6 months.

    6 months

Secondary Outcomes (4)

  • BMI ( Body Mass Index ) at Start

    Baseline

  • BMI at 6 Months

    6 months

  • Blood Pressure ( Systolic / Diastolic )

    Baseline

  • Systolic and Diastolic Blood Pressure

    6 months

Study Arms (2)

Control

NO INTERVENTION

Usual clinical health care

Intervention

EXPERIMENTAL

Behavioural program of education for health professionals. Standardized program of 6 hours for health professionals ( doctors and nurses )

Behavioral: Educational program 6-hour standardized

Interventions

Educational program 6-hour standardizedBEHAVIORAL

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

Also known as: Standardized educational programs, Patients safety
Intervention

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of diabetes
  • Aged between 45 and 75 years

You may not qualify if:

  • No data in informatic system
  • Severe illness
  • Controlled only by specialists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health Care. Catalan Health Institute. Tarragona-Reus

Reus, Tarragona, 43202, Spain

Location

Related Publications (1)

  • Cabre JJ, Ripoll M, Hernandez JM, Basora J, Bejarano F, Arija V. Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. BMC Public Health. 2011 Jun 5;11:430. doi: 10.1186/1471-2458-11-430.

    PMID: 21639938DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Cecilia Borau
Organization
Jordi Gol i Gurina Foundation
cborau@idiapjgol.org
34 934824617

Study Officials

  • Juan J Cabré, MD, PhD

    Catalan Institute of Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 16, 2010

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

June 1, 2010

Last Updated

March 29, 2011

Results First Posted

March 24, 2011

Record last verified: 2011-03

Locations

ES(1)