Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1). (AVADI-1)
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|ClinicalTrials.gov Identifier: NCT03478254|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment|
|Type 1 Diabetes Mellitus||Biological: Influenza vaccination Biological: Pneumococcal vaccination Biological: Hepatitis B Virus (HBV) vaccination|
Cross-sectional analysis about adherence to guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
All clinical variables are gathered from two EMR softwares (Mambrino XXI and Turriano).
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value < 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Adherence to Guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in Adult Patients With Type 1 Diabetes Mellitus (AVADI-1).|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza Vaccination status.
Biological: Influenza vaccination
Correct influenza vaccination status was considered in the following situation:
- Received at least one Influenza vaccine dose in the last year.
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Pneumococcal Vaccination status.
Biological: Pneumococcal vaccination
Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
Hepatitis B Virus (HBV) Vaccination
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Hepatitis B Virus (HBV) status.
Biological: Hepatitis B Virus (HBV) vaccination
Correct Hepatitis B Virus (HBV) vaccination status was considered in the following situation:
.- Received at least three consecutive doses of HBV vaccine during six consecutive months.
- Adherence to regional guidelines for the immunization of adults with type 1 diabetes mellitus (T1DM [ Time Frame: 1 year ]Adherence to Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
- Predictors of vaccination [ Time Frame: 1 year ]Any situation indentified as inducing greater vaccination rate.
- Relationship between adherence vaccination and related sick leaves [ Time Frame: 1 year ]Number and duration of related sick leaves.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478254
|Contact: Jesus Moreno-Fernandez, PhD||926278000 ext email@example.com|
|Contact: Angela Seco Segura, RN||926278000 ext firstname.lastname@example.org|
|Obispo Rafael Torija, St.||Recruiting|
|Ciudad Real, Spain, 13005|
|Contact: Jesus Moreno-Fernandez, MD, PhD 926278000 ext 79509 email@example.com|
|Study Chair:||Elena M Ortega Rodrigo||University of Castilla-La Mancha|
|Study Chair:||Jose Alberto Garcia Seco, RN||University of Castilla-La Mancha|
|Study Chair:||Fernando Garcia Seco||Universidad de Córdoba|
|Study Chair:||Angela M Seco Segura, RN||Castilla-La Mancha Health Service|