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Trial record 94 of 342 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Collaborators:
Castilla-La Mancha Health Service
University of Castilla-La Mancha
Information provided by (Responsible Party):
Jesús Moreno Fernández, Castilla-La Mancha Health Service

Brief Summary:
Observational study about adherence to guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Biological: Influenza vaccination Biological: Pneumococcal vaccination Biological: Hepatitis B Virus (HBV) vaccination

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Influenza Vaccination
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.

Pneumococcal Vaccination
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:

  • 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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Predictors of vaccination [ Time Frame: 1 year ]
    Any situation indentified as inducing greater vaccination rate.

  2. Relationship between adherence vaccination and related sick leaves [ Time Frame: 1 year ]
    Number and duration of related sick leaves.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients attended to care in consults during this period were eligible for chart review. Patients included in the analysis were required to be ≥18 years of age and be diagnosed of type 1 diabetes mellitus.
Criteria

Inclusion Criteria:

  • ≥18 years of age.
  • Diagnosed of Type 1 Diabetes Mellitus.
  • Be attended in Ciudad Real General University Hospital.

Exclusion Criteria:

  • Less than 18 years old.
  • Other types of diabetes mellitus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478254


Contacts
Contact: Jesus Moreno-Fernandez, PhD 926278000 ext 79509 jmorenof@sescam.jccm.es
Contact: Angela Seco Segura, RN 926278000 ext 79510 amsese@live.com

Locations
Spain
Obispo Rafael Torija, St. Recruiting
Ciudad Real, Spain, 13005
Contact: Jesus Moreno-Fernandez, MD, PhD    926278000 ext 79509    jmorenof@sescam.jccm.es   
Sponsors and Collaborators
Jesús Moreno Fernández
Castilla-La Mancha Health Service
University of Castilla-La Mancha
Investigators
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

Publications:
Responsible Party: Jesús Moreno Fernández, Endocrinology and Nutrition Service, MD, PhD, Castilla-La Mancha Health Service
ClinicalTrials.gov Identifier: NCT03478254     History of Changes
Other Study ID Numbers: C-127
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 1 year.
Access Criteria: Related investigation.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs