NCT03478254

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 11, 2021

Completed
Last Updated

January 11, 2021

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

March 20, 2018

Results QC Date

October 27, 2019

Last Update Submit

December 16, 2020

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Adherence to Regional Guidelines for the Immunization of Adults With Type 1 Diabetes Mellitus (T1DM

    Adherence to Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.

    1 year

Secondary Outcomes (2)

  • Patient Age According to Vaccination Status

    1 year

  • Number of Participants Who Have Taken Related Sick Leaves

    1 year

Study Arms (1)

Vaccination adherence

All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza Vaccination status, Pneumococcal Vaccination status and Hepatitis B Virus (HBV) status.

Biological: Influenza vaccinationBiological: Pneumococcal vaccinationBiological: Hepatitis B Virus (HBV) vaccination

Interventions

Influenza vaccinationBIOLOGICAL

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

Vaccination adherence
Pneumococcal vaccinationBIOLOGICAL

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) vaccinationBIOLOGICAL

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients attended to care in consults during this period were eligible for chart review. Patients included in the analysis were required to be ≥18 years of age and be diagnosed of type 1 diabetes mellitus.

You may qualify if:

  • ≥18 years of age.
  • Diagnosed of Type 1 Diabetes Mellitus.
  • Be attended in Ciudad Real General University Hospital.

You may not qualify if:

  • Less than 18 years old.
  • Other types of diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obispo Rafael Torija, St.

Ciudad Real, 13005, Spain

Location

Related Publications (6)

  • Shah BR, Hux JE. Quantifying the risk of infectious diseases for people with diabetes. Diabetes Care. 2003 Feb;26(2):510-3. doi: 10.2337/diacare.26.2.510.

    PMID: 12547890BACKGROUND

  • Muller LM, Gorter KJ, Hak E, Goudzwaard WL, Schellevis FG, Hoepelman AI, Rutten GE. Increased risk of common infections in patients with type 1 and type 2 diabetes mellitus. Clin Infect Dis. 2005 Aug 1;41(3):281-8. doi: 10.1086/431587. Epub 2005 Jun 16.

    PMID: 16007521BACKGROUND

  • Alcusky MJ, Pawasauskas J. Adherence to Guidelines for Hepatitis B, Pneumococcal, and Influenza Vaccination in Patients With Diabetes. Clin Diabetes. 2015 Jul;33(3):116-22. doi: 10.2337/diaclin.33.3.116.

    PMID: 26203204BACKGROUND

  • Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Epub 2012 Oct 4. English, Spanish.

    PMID: 23039989BACKGROUND

  • American Association of Diabetes Educators. Vaccination practices for hepatitis B, influenza, and pneumococcal disease for people with diabetes. Diabetes Educ. 2014 Jan-Feb;40(1):122-4. doi: 10.1177/0145721713513545. No abstract available.

    PMID: 24442103BACKGROUND

  • 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: 31582202DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Influenza VaccinesHepatitis B VaccinesVaccination

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesViral Hepatitis VaccinesImmunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Results Point of Contact

Title
Angela M. Seco Segura RN, Endocrinology and Nutrition Department.
Organization
Ciudad Real University Hospital. Castilla La Mancha Health Service.
amsese@live.com
926278000

Study Officials

  • Elena M Ortega Rodrigo

    University of Castilla-La Mancha

    STUDY CHAIR

  • Jose Alberto Garcia Seco, RN

    University of Castilla-La Mancha

    STUDY CHAIR

  • Fernando Garcia Seco

    Universidad de Córdoba

    STUDY CHAIR

  • Angela M Seco Segura, RN

    Castilla-La Mancha Health Service

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Endocrinology and Nutrition Service, MD, PhD

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 27, 2018

Study Start

December 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 31, 2018

Last Updated

January 11, 2021

Results First Posted

January 11, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

In request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
1 year.
Access Criteria
Related investigation.

Locations

ES(1)