Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1).
NCT ID: NCT03478254
Last Updated: 2021-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
300 participants
OBSERVATIONAL
2017-12-01
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Vaccination adherence
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status.
Influenza vaccination
Correct influenza vaccination status was considered in the following situation:
\- Received at least one Influenza vaccine dose in the last year.
Pneumococcal vaccination
Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
* One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.
* One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.
* One PPSV 23 dose in the last 5 years.
* One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.
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.
Interventions
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Influenza vaccination
Correct influenza vaccination status was considered in the following situation:
\- Received at least one Influenza vaccine dose in the last year.
Pneumococcal vaccination
Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
* One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.
* One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.
* One PPSV 23 dose in the last 5 years.
* One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed of Type 1 Diabetes Mellitus.
* Be attended in Ciudad Real General University Hospital.
Exclusion Criteria
* Other types of diabetes mellitus.
18 Years
ALL
No
Sponsors
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Castilla-La Mancha Health Service
OTHER
University of Castilla-La Mancha
OTHER
Jesús Moreno Fernández
OTHER
Responsible Party
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Jesús Moreno Fernández
Endocrinology and Nutrition Service, MD, PhD
Principal Investigators
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Elena M Ortega Rodrigo
Role: STUDY_CHAIR
University of Castilla-La Mancha
Jose Alberto Garcia Seco, RN
Role: STUDY_CHAIR
University of Castilla-La Mancha
Fernando Garcia Seco
Role: STUDY_CHAIR
Universidad de Córdoba
Angela M Seco Segura, RN
Role: STUDY_CHAIR
Castilla-La Mancha Health Service
Locations
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Obispo Rafael Torija, St.
Ciudad Real, , Spain
Countries
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References
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Shah BR, Hux JE. Quantifying the risk of infectious diseases for people with diabetes. Diabetes Care. 2003 Feb;26(2):510-3. doi: 10.2337/diacare.26.2.510.
Muller LM, Gorter KJ, Hak E, Goudzwaard WL, Schellevis FG, Hoepelman AI, Rutten GE. Increased risk of common infections in patients with type 1 and type 2 diabetes mellitus. Clin Infect Dis. 2005 Aug 1;41(3):281-8. doi: 10.1086/431587. Epub 2005 Jun 16.
Alcusky MJ, Pawasauskas J. Adherence to Guidelines for Hepatitis B, Pneumococcal, and Influenza Vaccination in Patients With Diabetes. Clin Diabetes. 2015 Jul;33(3):116-22. doi: 10.2337/diaclin.33.3.116.
Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Epub 2012 Oct 4. English, Spanish.
American Association of Diabetes Educators. Vaccination practices for hepatitis B, influenza, and pneumococcal disease for people with diabetes. Diabetes Educ. 2014 Jan-Feb;40(1):122-4. doi: 10.1177/0145721713513545. No abstract available.
Moreno-Fernandez J, Garcia-Seco JA, Rodrigo EMO, Segura AMS, Garcia-Seco F, Munoz-Rodriguez JR. Vaccination adherence to influenza, pneumococcal and hepatitis B virus in adult type 1 diabetes mellitus patients. Prim Care Diabetes. 2020 Aug;14(4):343-348. doi: 10.1016/j.pcd.2019.09.004. Epub 2019 Sep 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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C-127
Identifier Type: -
Identifier Source: org_study_id
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