Impact on Quality of Life and Burden of Disease in Adults With Herpes Zoster

NCT06667245 | Not Yet Recruiting

• 1 other identifier: V1.0_03.04.24
• Study Type: observational
• Target: 357
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Impact on quality of life and disease burden in adults with herpes zoster Prospective cohort study for the primary objective and the secondary objectives (1 and 2) and retrospective cohort study for the secondary objective 3. Disease or disorder under study: Patients with a herpes zoster (HZ) diagnosis.

Conditions

Herpes Zoster; Quality of Life; Immunization; Infection

Outcome Measures

Primary Outcomes (1)

• Quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.

  Measuring the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.

  Data will be collected for 1 year and then analyzed to respond to the outcomes

Secondary Outcomes (3)

• Quality of life according to the location of herpes zoster

  Data will be collected for 1 year and then analyzed to respond to the outcome

• Effectiveness of the vaccine against herpes zoster

  Data will be collected for 1 year and then analyzed to respond to the objective

• Economic impact and disease burden in terms of morbidity and mortality

  A retrospective analysis will be carried out, when the data has been analysed this outcome will be answered, in approximately 6 months.

Study Arms (1)

Patients > 18 years old who are going to be immunized against HZ

Patients \> 18 years old who are going to be immunized against HZ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective study: Patients \> 18 years of age who are to be immunized against HZ Retrospective study: Adults over 18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation hospital. Since the international classification of diseases changed from ICD 9 to ICD 10 in 2016, the codes to be used for the inclusion of patients in the study are described below. Patients diagnosed with herpes zoster (HZ). Study Population and Total Number of Patients: Based on the sample calculation, it is intended to include a total of 357 patients in the prospective study and 1,920 patients in the retrospective study.

You may not qualify if:

• Pregnant women
• Patients with altered level of consciousness (dementia and others) who do not complete the questionnaires
• ICD 9 053 Herpes zoster
• Includes:
• Herpes zoster
• Zone 053.0 With meningitis 053.1 With other central nervous system complications
• With unspecified nervous system complications
• Geniculate herpes zoster or Herpetic geniculate ganglionitis
• Postherpetic trigeminal neuralgia
• Postherpetic polyneuropathy
• Herpes zoster myelitis
• Other 053.2 With ophthalmic complications
• Herpes zoster dermatitis of eyelid or Herpes zoster ophthalmicus
• Herpes zoster keratoconjunctivitis
• Herpes zoster iridocyclitis zoster

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Related Links

• Patil A. Goldust M. Wollina U. Herpes zoster: A Review of Clinical Manifestations and Management. Viruses. \[Internet\]. 2022. \[Consultado 18 Feb 2024\]; 14(2)
• Kain A., Tizek L., Wecker H., Wallnöfer F., Biedermann T., Zink A. Evaluating public interest in herpes zoster in Germany by leveraging the internet: a retrospective search data analysis. BMC Public Health. \[Internet\]. 2023. \[Consultado 29 Mar 2024\]; 2
• Masa Calles J. López Perca N. Vila Cordero B. Carmona R. Vigilancia y epidemiología del herpes zóster en España. RevEsp Salud Pública.\[Internet\]. 2021. \[Consultado 18 Feb 2024\]; 95. (e1-13).
• Centro Nacional de Epidemiología. CIBERESP. Instituto de Salud Carlos III. Informe epidemiológico sobre la situación del Herpes Zóster en España. \[Internet\]. 2020. \[Consultado 18 Feb 2024\].
• Patkia A., Vorab A., Parikh R., Kolhapure S., Agrawal A., Dash R. Herpes zoster in outpatient departments of healthcare centers in India: a review of literatura. Human vaccines\&immunotherapeutics. \[Internet\]. 2021. \[Consultado 29 Mar 2024\].
• Ralph Tayyar R., Ho D. Herpes Simplex Virus and Varicella Zoster Virus Infections in Cancer Patients. Viruses. \[Internet\]. 2023. \[Consultado 28 Mar 2024\];15, 439.
• Van Oorschot D., McGirr A., Goulet P., Koochaki P., Pratiwadi R., Shah S., Curran D. A Cross-Sectional Concept Elicitation Study to Understand the Impact of Herpes Zoster on Patients' Health-Related Quality of Life. InfectDisTher. \[Internet\]. 2022.
• Sollie M., Jepsen P., Sørensen, JA. (2022). Patient-reported quality of life in patients suffering from acute herpes zoster-a systematic review with meta-analysis. British journal of pain. \[Internet\]. 2022. \[Consultado 28 Mar 2024\]; 15 16(4), 404-419.
• Díez Domingo J., Curran D., Cambronero MR., Garcia Martinez JA., Matthews S. Economic Burden and Impact on Quality of Life of Herpes Zoster in Spanish Adults Aged 50 Years or Older: A Prospective Cohort Study. Advances in therapy. \[Internet\]. 2021. \[C
• Matthews S., De Maria A., Passamonti M.,Ristori G., Loiacono I., Puggina A., Curran D. The Economic Burden and Impact on Quality of Life of Herpes Zoster and Postherpetic Neuralgia in Individuals Aged 50 Years or Older in Italy. Open ForumInfectDis. \[
• Zhao D, Suo L., Lu L., Pan J., Peng X., Wang Y., Pang X. Impact of herpes zoster and post-herpetic neuralgia on health-relate. Vaccine X. \[Internet\]. 2023. \[Consultado 28 Mar 2024\]; 15, 100415.
• Curran D., Hunjan M., El Ghachi A., El-Hahi Y., Bianco V., Ferreira G. Herpes zoster related healthcare burden and costs in immunocompromised (IC) and IC-free populations in England: an observational retrospective database analysis. BMJ Open. \[Interne
• Chen L., Li J., Liu H., Yang P., Zuo Y., Ye L. Interventions for zoster-associated pain: A retrospective study based on the clinical database.Front Neurol. \[Internet\]. 2022. \[Consultado 29 Mar 2024\];13:1056171.
• Lin CS., Lin YC., Lao HC., Chen CC. Interventional Treatments for Postherpetic Neuralgia: A Systematic Review. Pain Physician. \[Internet\]. 2019. \[Consultado 28 Mar 2024\]; 22,209-228.
• Zeng F., Wang M., Zhang D. Cost-effectiveness analysis of 5% lidocaine-medicated plaster compared with pregabalin for the treatment of post-herpetic neuralgia in China.Pain and therapy. \[Internet\]. 2021. \[Consultado 30 Mar 2024\]; 10(1), 675-689.
• Sollie M., Jepsen P., Sorensen JA. Patient-reported quality of life in patients suffering from acute herpes zoster-a systematic review with meta-analysis. British Journal of Pain. \[Internet\]. 2022. \[Consultado 18 Feb 2024\]; 16(4) 404-419.
• Hideo Hashizumea H., NakataniaE. ,Satoa Y., Gotoc H. , Yagic H., Miyachi Y. A new susceptibility index to predict the risk of severe herpes zoster-associated pain: A Japanese regional population-based cohort study, the Shizuoka study. Journal of Derma
• Centro Nacional de Epidemiología. CIBERESP. Instituto de Salud Carlos III. Informe epidemiológico sobre la situación del Herpes Zóster en España. \[Internet\]. Madrid; 2020. \[Consultado 18 Feb 2024\].
• Sicras-Mainar A., Navarro-Artieda R., Ibanez-Nolla J., Perez-Ronco J. Incidence, resource use and costs associated with postherpetic neuralgia: a population-based retrospective study. Rev Neurol. . \[Internet\].2012\[Consultado 10 Abr 2024\]; 55:449-461.

MeSH Terms

Conditions

Herpes Zoster; Infections

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases

Study Design

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

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: October 31, 2024
• Study Start: November 4, 2024
• Primary Completion: November 4, 2025
• Study Completion (Estimated): November 4, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

ES (1)