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

NCT05481801 | Completed

• 1 other identifier: C-549
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sick Leaves

  1 year and a half

• Hospital admission

  1 year and a half

• Death

  1 year and a half

Study Arms (1)

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; Biological: Influenza vaccination; Biological: Pneumococal vaccination; Biological: Hepatitis B Virus (HBV) vaccination

Interventions

Covid-19 vaccination BIOLOGICAL

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.

Vaccination adherence

Influenza vaccination BIOLOGICAL

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

Vaccination adherence

Pneumococal 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.

Vaccination adherence

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.

Vaccination adherence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Other diabetes types.
• Younger than 18 years.

Sponsors & Collaborators

• Castilla-La Mancha Health Service: lead

Study Sites (1)

Ciudad Real General University Hospital

Ciudad Real, 13005, Spain

Location

Related Publications (3)

• 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.

  PMID: 31582202 RESULT

• 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.

  PMID: 34613871 RESULT

• 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.

  PMID: 35689648 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

heterologous prime boost COVID-19 vaccination; Influenza Vaccines; Hepatitis B Vaccines; Vaccination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines; Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 1, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)