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| Name | Class |
|---|---|
| Department of Health, Generalitat de Catalunya | OTHER_GOV |
| Fundación Avedis Donabedian | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational program 6-hour standardized | Behavioral | 6-hour standardized program for adults ( doctors and nurses ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Haemoglobin A1c at Start | Baseline | |
| Glycosylated Haemoglobin A1c at 6 Months | Glycohemoglobin A1c at 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI ( Body Mass Index ) at Start | Baseline | |
| BMI at 6 Months | 6 months | |
| Blood Pressure ( Systolic / Diastolic ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan J Cabré, MD, PhD | Catalan Institute of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Care. Catalan Health Institute. Tarragona-Reus | Reus | Tarragona | 43202 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21639938 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Behavioural program of education for health professionals of the study |
| FG001 | Control Group | Usual healthcare of diabetics patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Behavioural program of education for health professionals of the study |
| BG001 | Control Group | Usual healthcare of diabetics patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycosylated Haemoglobin A1c at Start | Posted | Dec 2009 | Mean | Standard Deviation | Percentage | Baseline |
|
|
6 months
Serious events are death or another event due to the study's protocol. As this is an educational project in professionals, we had been not any serious event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Intervention group: educational program |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug interactions not serious | Investigations | Systematic Assessment | The assessment for drug interactions was performed by informatic methods. The adverse event was concomitant treatment with gemfibrozil plus glitazones, that is not recommended. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecilia Borau | Jordi Gol i Gurina Foundation | 34 934824617 | cborau@idiapjgol.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Baseline |
| Systolic and Diastolic Blood Pressure | 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | BMI ( Body Mass Index ) at Start | Posted | Dec 2009 | Mean | Standard Deviation | kg/m2 | Baseline |
|
|
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| Secondary | BMI at 6 Months | Posted | Dec 2009 | Mean | Standard Deviation | kg/m2 | 6 months |
|
|
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| Primary | Glycosylated Haemoglobin A1c at 6 Months | Glycohemoglobin A1c at 6 months. | Posted | Dec 2009 | Mean | Standard Deviation | Percentage | 6 months |
|
|
|
|
| Secondary | Blood Pressure ( Systolic / Diastolic ) | Posted | Dec 2009 | Mean | Standard Deviation | mmHg | Baseline |
|
|
|
| Secondary | Systolic and Diastolic Blood Pressure | Posted | Dec 2009 | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
|
| 0 |
| 3,307 |
| 2 |
| 52 |
| EG001 | Control Group | Usual healthcare | 0 | 3,523 | 1 | 87 |
|
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