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A National Registry For Patients With Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT03289585
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Tracking Information
First Submitted Date September 11, 2017
First Posted Date September 21, 2017
Last Update Posted Date July 22, 2021
Actual Study Start Date August 2015
Estimated Primary Completion Date February 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2019)
  • Skin-related quality of life [ Time Frame: Baseline ]
    Quality of life as measured using standardized Dermatology Quality of Life Index
  • Presence and severity of depression [ Time Frame: Baseline ]
    Presence and severity of depression as measured using standardized Beck Depression Inventory
  • Skin-related of life [ Time Frame: Baseline ]
    Quality of life as measured using standardized SkinDex questionnaires
  • Subject-reported subject health [ Time Frame: Baseline ]
    Subject-reported subject health as measured using the standardized SF-36 questionnaires
  • Degree of enjoyment and satisfaction experienced by subjects in daily functioning. [ Time Frame: Baseline ]
    Degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning as measured by the standardized Quality of Life Enjoyment and Satisfaction Questionnaire-short form.
  • Employment and economic productivity [ Time Frame: Baseline ]
    Self-reported employment and economic productivity as measured by a standardized health economic questionnaire
Original Primary Outcome Measures
 (submitted: September 18, 2017)
  • Quality of life [ Time Frame: Baseline ]
    Quality of life as measured using standardized Dermatology Quality of Life Index
  • Presence and severity of depression [ Time Frame: Baseline ]
    Presence and severity of depression as measured using standardized Beck Depression Inventory
  • Quality of life [ Time Frame: Baseline ]
    Quality of life as measured using standardized SkinDex questionnaires
  • Subject-reported subject health [ Time Frame: Baseline ]
    Subject-reported subject health as measured using standardized SF-36 questionnaires
  • Degree of enjoyment and satisfaction experienced by subjects in daily functioning. [ Time Frame: Baseline ]
    Degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning as measured by the standardized Quality of Life Enjoyment and Satisfaction Questionnaire-short form.
  • Employment and economic productivity [ Time Frame: Baseline ]
    Self-reported employment and economic productivity as measured by a standardized health economic questionnaire
Change History
Current Secondary Outcome Measures
 (submitted: September 18, 2017)
  • Change in quality of life [ Time Frame: At 6 months ]
    Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation
  • Change in presence and severity of depression [ Time Frame: At 6 months ]
    Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation
  • Change in quality of life [ Time Frame: At 6 months ]
    Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation
  • Change in subject-reported subject health [ Time Frame: At 6 months ]
    Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation
  • Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning [ Time Frame: At 6 months ]
    Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning as measured by the standardized Quality of Life Enjoyment and Satisfaction Questionnaire-short form after treatment initiation
  • Change in self-reported employment and economic productivity [ Time Frame: At 6 months ]
    Change in self-reported employment and economic productivity as measured by a standardized health economic questionnaire after treatment initiation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A National Registry For Patients With Hidradenitis Suppurativa
Official Title Development and Maintenance of a National Registry For Patients With Hidradenitis Suppurativa
Brief Summary The goal of this study is to get a better understanding of the skin condition, Hidradenitis Suppurativa, and to find out how the disease affects quality of life. The investigators hope this information will help improve treatment for this skin condition.
Detailed Description The goal of this study is to get a better understanding of the skin condition, Hidradenitis Suppurativa, and to find out how the disease affects quality of life. The investigators will utilize a compilation of validated questionnaires including the Beck Depression Inventory form, Dermatology Life Quality Index (DLQI), Skindex, SF-36 health survey, the Quality of Life Enjoyment and Satisfaction Questionnaire- short form (Q-LES-Q-SF) and the Employment/Productivity Health Economic Questionnaire as well as other relevant clinical data. The investigators will additionally collect a modified Hidradenitis Suppurativa Lesion, Area, and Severity Index (HS-LASI) (or other appropriate disease severity score as determined by the team) from the physician of each enrollee. The investigators hope this information will help improve treatment for this skin condition.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy adults (ages 18-99) with a diagnosis of Hidradenitis Suppurativa
Condition Hidradenitis Suppurativa
Intervention Not Provided
Study Groups/Cohorts Hidradenitis Suppurativa Cohort
Patients with Hidradenitis Suppurativa (ages 18-99 years old) will be asked to complete a series of questionnaires on how Hidradenitis Suppurativa impacts quality of life.
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 Recruiting
Estimated Enrollment
 (submitted: September 18, 2017)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 14, 2022
Estimated Primary Completion Date February 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects 18-99 years of age who have a diagnosis of Hidradenitis Suppurativa (as deemed by a physician at the Montefiore Hidradenitis Suppurativa Treatment Center)

Exclusion Criteria:

  • Patients without a diagnosis of Hidradenitis Suppurativa or under the age of 18
  • Patients who are unable to answer given questions within the 6 surveys
  • Patient who are unable to be clinically evaluated by a Montefiore physician
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Steve R Cohen, MD, MPH srcohen@montefiore.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03289585
Other Study ID Numbers 2014-3835 SRC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data to other researchers
Responsible Party Montefiore Medical Center
Study Sponsor Montefiore Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Steven R Cohen, MD, MPH Albert Einstein College of Medicine/Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date July 2021