Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2)
NCT ID: NCT05481801
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
300 participants
OBSERVATIONAL
2022-09-01
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1).
NCT03478254
The ADHERENCE Index - the Indicator of Effective Coping With the Requirements of the Disease of Children and Adolescents With Type 1 Diabetes
NCT01580462
Comprehensive Care in Type 1 Diabetes and Associated Outcomes
NCT03835195
Assessing Adherence to Digital Health Technologies Among Hispanic/Latino Adults With or At Risk of Type 2 Diabetes:
NCT04820348
Clinical Efficacy of a Diabetes Educational Program to Improve Flash Adherence in Type 1 Diabetes Patients
NCT05570162
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age: 18 yrs. or older
Exclusion Criteria
* Younger than 18 years.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Castilla-La Mancha Health Service
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ciudad Real General University Hospital
Ciudad Real, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1016/j.pcd.2019.09.004. Epub 2019 Sep 30.
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: 10.1080/21645515.2021.1973882. Epub 2021 Oct 6.
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/jpepsy/jsac048.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C-549
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.