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

Type 1 Diabetes Clinical Trial

— AVADI-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481801
• Other study ID #: C-549
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Age: 18 yrs. or older

Exclusion Criteria:

• Other diabetes types.

• Younger than 18 years.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.
• Influenza vaccination
Correct influenza vaccination status was considered in the following situation: - Received at least one Influenza vaccine dose in the last year.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Ciudad Real General University Hospital	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Giatraki V, Dimitriou H, Pappas A, Mamoulakis D, Makris G, Galanakis E, Perdikogianni C. Vaccine coverage in children, adolescents and adults with type 1 diabetes and their close contacts in Crete. Hum Vaccin Immunother. 2021 Nov 2;17(11):4291-4298. doi: — View Citation

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. — View Citation

Wang CH, Jones J, Hilliard ME, Tully C, Monaghan M, Marks BE, Hildebrandt T, Streisand R. Correlates and Patterns of COVID-19 Vaccination Intentions among Parents of Children with Type 1 Diabetes. J Pediatr Psychol. 2022 Aug 12;47(8):883-891. doi: 10.1093 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination adherence	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	Sick Leaves	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
Secondary	Hospital admission	Number of hospital admission according to vaccination status (vaccinated or not vaccinated) for Covid-19, pneumococcus, influenza and HBV.	1 year and a half
Secondary	Death	Mortality rate according to vaccination status	1 year and a half