Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)
Study Details
Study Description
Brief Summary
Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Vaccination adherence [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
Secondary Outcome Measures
- Sick Leaves [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).
- Hospital admission [1 year and a half]
Number of hospital admission according to vaccination status (vaccinated or not vaccinated) for Covid-19, pneumococcus, influenza and HBV.
- Death [1 year and a half]
Mortality rate according to vaccination status
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 1 diabetes
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Age: 18 yrs. or older
Exclusion Criteria:
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Other diabetes types.
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Younger than 18 years.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Castilla-La Mancha Health Service
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C-549