Clinical trial NCT02487472: Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France
Official title: Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France: the POSTHER Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Zoster
Keywords: France
Post-herpetic neuralgia
Herpes zoster
Economic burden of disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 106
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study has been designed to include 250 patients ≥ 50 years old with a first visit for diagnosis of HZ during a 6-month inclusion period (HZ cohort) and 40 expected cases of PHN after 3 months of HZ rash onset.

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.

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

Primary outcomes:
measure: Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
timeFrame: Before inclusion and at inclusion (Month 0)
measure: Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit
timeFrame: At Inclusion (Month 0)
measure: Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
timeFrame: Cumulatively up to Month 3
measure: Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
timeFrame: From Month 3 to Month 6
measure: Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
timeFrame: From Month 6 to Month 9
Secondary outcomes:
measure: Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
timeFrame: At inclusion (Month 0), Month 1 and Month 3
measure: Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
timeFrame: At inclusion (Month 0), Month 1, 3, 6 and 9
measure: Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie
timeFrame: At inclusion (Month 0)
measure: Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort
timeFrame: At inclusion (Month 0), Month 1, 3, 6 and 9
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: