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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

Tracking Information
First Submitted Date June 25, 2015
First Posted Date July 1, 2015
Results First Submitted Date January 9, 2019
Results First Posted Date September 4, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date January 19, 2016
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2019)
  • 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.
  • 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.
  • 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.
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: June 29, 2015)
  • HZ-related direct medical costs and indirect costs [ Time Frame: At Month 0 ]
    HZ-related direct medical costs and indirect costs, estimated with the valorization of the HZ healthcare resources used (medical visits, emergency room [≤ 24h], hospitalization [≥ 24h], drugs prescribed, procedures performed or prescribed in relation with HZ or PHN, as well as patient sick leave).
  • HZ-related direct medical costs and indirect costs [ Time Frame: At Month 1 ]
    HZ-related direct medical costs and indirect costs, estimated with the valorization of the HZ healthcare resources used (medical visits, emergency room [≤ 24h], hospitalization [≥ 24h], drugs prescribed, procedures performed or prescribed in relation with HZ or PHN, as well as patient sick leave).
  • HZ-related direct medical costs and indirect costs [ Time Frame: At Month 3 ]
    HZ-related direct medical costs and indirect costs, estimated with the valorization of the HZ healthcare resources used (medical visits, emergency room [≤ 24h], hospitalization [≥ 24h], drugs prescribed, procedures performed or prescribed in relation with HZ or PHN, as well as patient sick leave).
  • PHN-related direct medical costs and indirect costs [ Time Frame: At Month 0 ]
    PHN-related direct medical costs and indirect costs, estimated with the valorization of the PHN healthcare resources used (medical visits, emergency room [≤ 24h], hospitalization [≥ 24h], drugs prescribed, procedures performed or prescribed in relation with HZ or PHN, as well as patient sick leave).
  • PHN-related direct medical costs and indirect costs [ Time Frame: At Month 1 ]
    PHN-related direct medical costs and indirect costs, estimated with the valorization of the PHN healthcare resources used (medical visits, emergency room [≤ 24h], hospitalization [≥ 24h], drugs prescribed, procedures performed or prescribed in relation with HZ or PHN, as well as patient sick leave).
  • PHN-related direct medical costs and indirect costs [ Time Frame: At Month 3 ]
    PHN-related direct medical costs and indirect costs, estimated with the valorization of the PHN healthcare resources used (medical visits, emergency room [≤ 24h], hospitalization [≥ 24h], drugs prescribed, procedures performed or prescribed in relation with HZ or PHN, as well as patient sick leave).
  • PHN-related direct medical costs and indirect costs [ Time Frame: At Month 6 ]
    PHN-related direct medical costs and indirect costs, estimated with the valorization of the PHN healthcare resources used (medical visits, emergency room [≤ 24h], hospitalization [≥ 24h], drugs prescribed, procedures performed or prescribed in relation with HZ or PHN, as well as patient sick leave).
  • PHN-related direct medical costs and indirect costs [ Time Frame: At Month 9 ]
    PHN-related direct medical costs and indirect costs, estimated with the valorization of the PHN healthcare resources used (medical visits, emergency room [≤ 24h], hospitalization [≥ 24h], drugs prescribed, procedures performed or prescribed in relation with HZ or PHN, as well as patient sick leave).
Change History
Current Secondary Outcome Measures
 (submitted: September 2, 2019)
  • 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.
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: June 29, 2015)
  • HZ severity [ Time Frame: At Months 0, 1 and 3 ]
    HZ severity using three categories for last 24h worst pain from ZBPI questionnaire: mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain).
  • Quality of life and utilities in HZ cohort [ Time Frame: At Months 0, 1 and 3 ]
    Quality of life and utilities was assessed using EQ-5D 5L heath state
  • PHN severity [ Time Frame: At Months 0, 1, 3, 6 and 9 ]
    PHN severity using three categories for last 24h worst pain from ZBPI questionnaire: mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain).
  • Quality of life and utilities in PHN cohort [ Time Frame: At Months 0, 1, 3, 6 and 9 ]
    Quality of life and utilities was assessed using EQ-5D 5L heath state
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Herpes Zoster
Intervention Other: Data collection
Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire
Study Groups/Cohorts 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.
Intervention: Other: Data collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 2, 2019)
106
Original Estimated Enrollment
 (submitted: June 29, 2015)
250
Actual Study Completion Date August 28, 2017
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02487472
Other Study ID Numbers 201926
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2019