Clinical trial NCT06667245: Impact on Quality of Life and Burden of Disease in Adults With Herpes Zoster
Official title: Impact on Quality of Life and Burden of Disease in Adults With Herpes Zoster
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Herpes Zoster
Quality of Life
Immunization; Infection
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life of patients with a history of herpes zoster who attend the immunization unit of the Jiménez Díaz Foundation University Hospital.
timeFrame: Data will be collected for 1 year and then analyzed to respond to the outcomes
Secondary outcomes:
measure: Quality of life according to the location of herpes zoster
timeFrame: Data will be collected for 1 year and then analyzed to respond to the outcome
measure: Effectiveness of the vaccine against herpes zoster
timeFrame: Data will be collected for 1 year and then analyzed to respond to the objective
measure: Economic impact and disease burden in terms of morbidity and mortality
timeFrame: A retrospective analysis will be carried out, when the data has been analysed this outcome will be answered, in approximately 6 months.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
Study officials:
References: