Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2) (AVADI-2)

February 7, 2023 updated by: Castilla-La Mancha Health Service
Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cross-sectional analysis about adherence to guidelines for Covid-19, 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

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Ciudad Real, Spain, 13005
        • Ciudad Real General University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All type 1 diabetes patients attendet at the Ciudad Real General University Hospital.

Description

Inclusion Criteria:

  • Type 1 diabetes
  • Age: 18 yrs. or older

Exclusion Criteria:

  • Other diabetes types.
  • Younger than 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccination adherence
All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Covid-19, Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status.
Biological: Covid-19 vaccination

Correct Covid19 vaccination status was considered in the following situation:

Received at least two Covid-19 vaccine doses being the last in the last 6 months.

Biological: Influenza vaccination

Correct influenza vaccination status was considered in the following situation:

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

Biological: Pneumococal 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination adherence
Time Frame: 1 year and a half
Adherence ratio (number of vaccinated patients/total number of patients) to regional guidelines for the Immunization for Covid-19, pneumococcus, influenza and HBV of Adults With Type 1 Diabetes Mellitus
1 year and a half

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sick Leaves
Time Frame: 1 year and a half
Total number of related sick leaves due to Covid-19, pneumococcus, influenzae or HBV according to vaccination status (vaccinated or not vaccinated).
1 year and a half
Hospital admission
Time Frame: 1 year and a half
Number of hospital admission according to vaccination status (vaccinated or not vaccinated) for Covid-19, pneumococcus, influenza and HBV.
1 year and a half
Death
Time Frame: 1 year and a half
Mortality rate according to vaccination status
1 year and a half

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2022

Primary Completion (ACTUAL)

December 1, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (ACTUAL)

August 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical IPD will be available at request from others researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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