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

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ClinicalTrials.gov Identifier: NCT02487472
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment
Herpes Zoster Other: Data collection

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.

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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France: the POSTHER Study
Actual Study Start Date : January 19, 2016
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles

Group/Cohort Intervention/treatment
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.
Other: Data collection
Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire




Primary Outcome Measures :
  1. Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. [ Time Frame: Before inclusion and at inclusion (Month 0) ]
    Evaluation of HZ and PHN related direct medical costs were done by the drugs prescribed before and at inclusion. The drugs prescribed were defined as a direct cost.

  2. Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit [ Time Frame: At Inclusion (Month 0) ]
    Evaluation of HZ and PHN related indirect costs, estimated by direct medical costs were done by the sick leave prescription and medical visit at inclusion. Sick leave prescriptions were defined as an indirect medical cost and medical visits were defined as a direct medical cost.

  3. Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits [ Time Frame: Cumulatively up to Month 3 ]
    Evaluation of HZ and PHN related direct medical costs were done by drugs prescribed, sick leaves prescribed, medical visits to a specialist and patient reference to a hospital.

  4. Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits [ Time Frame: From Month 3 to Month 6 ]
    Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 3 to month 6 for the PHN cohort

  5. Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits [ Time Frame: From Month 6 to Month 9 ]
    Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 6 to month 9 for the PHN cohort


Secondary Outcome Measures :
  1. Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire [ Time Frame: At inclusion (Month 0), Month 1 and Month 3 ]

    HZ and PHN severity was evaluated using 3 categories- mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain) for the last 24 hour worst pain.

    The Zoster Brief Pain Inventory (ZBPI) questionnaire is a self-administered form to assess HZ pain and burden associated with HZ pain using scales from:

    • 0 for no pain to 10 for the most horrible pain that can be imagined,
    • 0 for no improvement to 100% for full improvement with painkiller,
    • 0 for no burden to 10 for full burden.

  2. Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire [ Time Frame: At inclusion (Month 0), Month 1, 3, 6 and 9 ]
    HZ and PHN severity was evaluated using 3 categories- mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain) for the last 24 hour worst pain.

  3. Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie [ Time Frame: At inclusion (Month 0) ]

    Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS).

    EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single mean index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A mean of this health state was recorded for subjects analyzed in this outcome measure


  4. Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort [ Time Frame: At inclusion (Month 0), Month 1, 3, 6 and 9 ]

    Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS).

    EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A median of this health state was recorded for subjects analyzed in this outcome measure




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487472


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] October 17, 2014
Statistical Analysis Plan  [PDF] November 3, 2017

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02487472    
Other Study ID Numbers: 201926
First Posted: July 1, 2015    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019
Last Verified: August 2019
Keywords provided by GlaxoSmithKline:
France
Post-herpetic neuralgia
Herpes zoster
Economic burden of disease
Additional relevant MeSH terms:
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Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections