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Completed

NCT Number: NCT03478254

Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1).

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

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Obispo Rafael Torija, St.

Ciudad Real, 13005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influenza vaccination

Biological

Correct influenza vaccination status was considered in the following situation:

  • Received at least one Influenza vaccine dose in the last year.

Pneumococcal vaccination

Biological

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

Biological

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 outcomes

  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 outcomes

  1. Patient Age According to Vaccination Status

    Time frame: 1 year

    Age (years)

  2. Number of Participants Who Have Taken Related Sick Leaves

    Time frame: 1 year

    Number of patients who have taken related sick leaves.

Sponsors and collaborators

Lead sponsor

Jesús Moreno Fernández

Other

Collaborators

  • Castilla-La Mancha Health Service
  • University of Castilla-La Mancha

Registry information

Official study title

Adherence to Guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in Adult Patients With Type 1 Diabetes Mellitus (AVADI-1).

Acronym: AVADI-1

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2018
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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