Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France

NCT ID: NCT02487472

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-19
• Study Completion Date: 2017-08-28

Brief Summary

The purpose of this study is to assess the burden of Herpes zoster (HZ) and post-herpetic neuralgia (PHN) among people ≥ 50 years old in France, in terms of healthcare resources used, medical direct and indirect costs, as well as pain severity and impact on quality of life.

Detailed Description

• An observational, prospective cohort study of patients ≥ 50 years old with a Herpes Zoster (HZ) diagnosis, carried out by a national random sample of community first line practitioners concerned by HZ diagnosis: general practitioners, dermatologists and ophthalmologists.
• All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses and without history of previous HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved.
• All Patients of the HZ cohort presenting a Post-herpetic neuralgia (PHN) 3 months after onset of the HZ rash onset will be included secondarily in the PHN cohort
• Patients of the HZ cohort will be followed-up for 3 months (i.e. 1 and 3 months after HZ rash onset) and patients of the PHN cohort will be followed-up for additional 6 months (i.e., 6 and 9 months after HZ rash onset) using phone interviews with a nurse.
• 250 cases of HZ and 40 cases of PHN are expected, with the hypothesis of 16% of PHN 3 months after HZ rash onset.

Conditions

Herpes Zoster

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HZ cohort

All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses and no earlier case of HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved.

Data collection

Intervention Type: OTHER

Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire

Interventions

Data collection

Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• For HZ cohort

• Patient with a first visit for a diagnosis of HZ and who attend the clinic within two week of the HZ start of symptoms,
• Without history of previous HZ,
• ≥ 50 years old,
• Who agree to participate and signed informed consent,
• Able to understand the study, to complete self-administered questionnaires and to answer phone interviews.
• For PHN cohort

• All Patients of the HZ cohort presenting PHN 3 months after onset of the HZ rash onset will be included in the PHN cohort. PHN will be defined as the presence of HZ-associated severe pains: ≥ 3 of the ZBPI item "worst pain".

Exclusion Criteria

• None

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

201926

Identifier Type: -

Identifier Source: org_study_id