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| Name | Class |
|---|---|
| Castilla-La Mancha Health Service | OTHER |
| University of Castilla-La Mancha | OTHER |
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Observational study about adherence to guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
Cross-sectional analysis about adherence to guidelines for 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccination | Biological | Correct influenza vaccination status was considered in the following situation: - Received at least one Influenza vaccine dose in the last year. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Age According to Vaccination Status | Age (years) | 1 year |
| Number of Participants Who Have Taken Related Sick Leaves | Number of patients who have taken related sick leaves. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obispo Rafael Torija, St. | Ciudad Real | 13005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12547890 | Background | 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. | |
| 16007521 | Background | 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. |
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In request.
1 year.
Related investigation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Vaccination | All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status. Influenza vaccination: Correct influenza vaccination status was considered in the following situation: - Received at least one Influenza vaccine dose in the last year. Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
HBV vaccination: Correct HBV vaccination status was considered in the following situation: .- Received at least three consecutive doses of HBV vaccine during six consecutive months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
White caucasian >18 yrs type 1 diabetes mellitus patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Adherence Vaccination | All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, pneumococcal and HBV vaccination status. Influenza vaccination: Correct influenza vaccination status was considered in the following situation: - Received at least one Influenza vaccine dose in the last year. Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
HBV vaccination: Correct HBV vaccination status was considered in the following situation: .- Received at least three consecutive doses of HBV vaccine during six consecutive months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 year |
|
Adverse Events were not collected
Adverse Events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adherence Vaccination | All type 1 diabetes adults patients attended in Ciudad Real General University Hospital willl be checked for Influenza, Pneumococcal and HBV Vaccination status. Influenza vaccination: Correct influenza vaccination status was considered in the following situation: - Received at least one Influenza vaccine dose in the last year. Pneumococcal vaccination: Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
HBV vaccination: Correct 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela M. Seco Segura RN, Endocrinology and Nutrition Department. | Ciudad Real University Hospital. Castilla La Mancha Health Service. | 926278000 | 79510 | amsese@live.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2017 | Jul 14, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2017 | Jul 14, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2017 | Aug 11, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D017325 | Hepatitis B Vaccines |
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Pneumococcal vaccination | Biological | Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
|
|
| 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. |
|
| 1 year |
| 26203204 | Background | 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. |
| 23039989 | Background | 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. |
| 24442103 | Background | 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. |
| 31582202 | Derived | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
|
| Secondary | Patient Age According to Vaccination Status | Age (years) | Posted | Mean | Standard Deviation | years | 1 year |
|
|
|
| Secondary | Number of Participants Who Have Taken Related Sick Leaves | Number of patients who have taken related sick leaves. | Posted | Number | participants | 1 year |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014761 |
| Viral Hepatitis Vaccines |
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
|
| Age : HBV pneumoccocal vaccination |
|