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

October 30, 2024 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Impact on quality of life and disease burden in adults with herpes zoster Contents

HYPOTHESIS AND OBJECTIVES OF THE STUDY 3.1 Hypothesis: Herpes zoster significantly affects the quality of life of those who suffer from it with a high disease burden.

3.2 Primary outcomes: To measure the quality of life of patients with a history of herpes zoster who attend the immunization unit of the Fundación Jiménez Díaz University Hospital.

3.3 Secondary outcomes

  1. Evaluating the quality of life according to the location of the zoster (postherpetic neuralgia, ophthalmic zoster, etc.)
  2. Evaluating the effectiveness of the vaccine against herpes zoster in terms of number of episodes, severity and quality of life.
  3. Evaluating the economic impact and disease burden in terms of morbidity and mortality in adult with herpes zoster

TYPE OF STUDY AND DESIGN

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.

SUBJECT SELECTION 5.1 Prospective cohort study Inclusion criteria Patients > 18 years of age who are to be immunised against HZ

Exclusion criteria:

  • Pregnant women
  • Patients with altered level of consciousness (dementia and others) who do not complete the questionnaires
  • Patients who do not wish to participate in the study 5.2 Retrospective cohort study Inclusion criteria
  • Adults over 18 years of age with a diagnosis of HZ in the CMBD from 2012 to 2023 at the Jiménez Díaz Foundation. 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.

ICD 9 053 Herpes zoster Includes:

Herpes zoster Zone 053.0 With meningitis 053.1 With other central nervous system complications 053.10 With unspecified nervous system complications 053.11 Geniculate herpes zoster or Herpetic geniculate ganglionitis 053.12 Postherpetic trigeminal neuralgia 053.13 Postherpetic polyneuropathy 053.14 Herpes zoster myelitis 053.19 Other 053.2 With ophthalmic complications 053.20 Herpes zoster dermatitis of eyelid or Herpes zoster ophthalmicus 053.21 Herpes zoster keraconjunctivitis 053.22 Herpes zoster iridocyclitis 053.29 Other 053.7 With other complications specific 053.71 Otitis externa due to herpes zoster 053.79 Other 053.8 With unspecified complications 053.9 Herpes zoster without complication Herpes zoster NOS ICD 10 B02 Herpes zoster Includes: - herpes - zone B02.0 Encephalitis due to herpes zoster Meningoencephalitis due to herpes zoster B02.1 Meningitis due to herpes zoster B02.2 Herpes zoster with other nervous system involvement B02.21 Postherpetic geniculate ganglionitis B02.22 Postherpetic trigeminal neuralgia B02.23 Postherpetic polyneuropathy B.02.24 Postherpetic myelitis or Herpes zoster myelitis B02.29 Other postherpetic nervous system involvement or Postherpetic radiculopathy B02.3 Ocular herpes zoster B02.30 Ocular herpes zoster, unspecified B02.31 Herpes zoster conjunctivitis B02.32 Herpes zoster iridocyclitis B02.33 Herpes zoster keratitis or Herpes zoster keratoconjunctivitis B02.34 Herpes zoster scleritis B02.39 Other herpes zoster eye diseases or Herpes zoster blepharitis B02.7 Disseminated herpes zoster B02.8 Herpes zoster with other complications Herpes zoster otitis externa B02.9 Uncomplicated herpes zoster Herpes zoster

Study Type

Observational

Enrollment (Estimated)

357

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Universitario Fundación Jiménez Díaz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

1 Prospective cohort study Inclusion criteria Patients > 18 years of age who are to be immunized against HZ

Exclusion criteria:

  • Pregnant women
  • Patients with altered level of consciousness (dementia and others) who do not complete the questionnaires
  • Patients who do not wish to participate in the study 5.2 Retrospective cohort study Inclusion criteria Adults >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 2106, the codes to be used for the inclusion of patients in the study are described below.

ICD 9 053 Herpes zoster

Includes:

  • Herpes zoster
  • Zone 053.0 With meningitis 053.1 With other central nervous system complications
  • 053.10 With unspecified nervous system complications
  • 053.11 Geniculate herpes zoster or Herpetic geniculate ganglionitis
  • 053.12 Postherpetic trigeminal neuralgia
  • 053.13 Postherpetic polyneuropathy
  • 053.14 Herpes zoster myelitis
  • 053.19 Other 053.2 With ophthalmic complications
  • 053.20 Herpes zoster dermatitis of eyelid or Herpes zoster ophthalmicus
  • 053.21 Herpes zoster keratoconjunctivitis
  • 053.22 Herpes zoster iridocyclitis zoster
  • 053.29 Other 053.7 With other specific complications
  • 053.71 Otitis externa due to herpes zoster
  • 053.79 Other 053.8 With unspecified complications 053.9 Herpes zoster without complication Herpes zoster NOS ICD 10 B02 Herpes zoster

Includes:

  • herpes
  • zona B02.0 Encephalitis due to herpes zoster Meningoencephalitis due to zoster B02.1 Meningitis due to herpes zoster B02.2 Herpes zoster with other nervous system involvement
  • B02.21 Postherpetic geniculate ganglionitis
  • B02.22 Postherpetic trigeminal neuralgia
  • B02.23 Postherpetic polyneuropathy
  • B.02.24 Myelitis Postherpetic myelitis
  • B02.29 Other postherpetic nervous system involvement
  • B02.3 Ocular herpes zoster
  • B02.30 Ocular herpes zoster, unspecified
  • B02.31 Herpes zoster conjunctivitis
  • B02.32 Herpes zoster iridocyclitis
  • B02.33 Herpes zoster keratitis
  • B02.34 Herpes zoster scleritis
  • B02.39 Other herpes zoster eye disease
  • B02.7 Disseminated herpes zoster
  • B02.8 Herpes zoster with other complications
  • B02.9 Uncomplicated herpes zoster
  • B02.39 Herpes zoster otitis externa NEOM

Exclusion criteria:

Patients who are vaccinated against HZV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.
Time Frame: Data will be collected for 1 year and then analyzed to respond to the outcomes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life according to the location of herpes zoster
Time Frame: Data will be collected for 1 year and then analyzed to respond to the outcome
Evaluate quality of life according to the location of herpes zoster (postherpetic neuralgia, ophthalmic zoster, etc.)
Data will be collected for 1 year and then analyzed to respond to the outcome
Effectiveness of the vaccine against herpes zoster
Time Frame: Data will be collected for 1 year and then analyzed to respond to the objective
Evaluating the effectiveness of the herpes zoster vaccine in terms of the number of episodes, severity and quality of life.
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
Time Frame: A retrospective analysis will be carried out, when the data has been analysed this outcome will be answered, in approximately 6 months.
Economic impact and burden of disease in terms of morbidity and mortality of adult patients with herpes zoster
A retrospective analysis will be carried out, when the data has been analysed this outcome will be answered, in approximately 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 4, 2024

Primary Completion (Estimated)

November 4, 2025

Study Completion (Estimated)

November 4, 2026

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1.0_03.04.24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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