<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03289585</url>
  </required_header>
  <id_info>
    <org_study_id>2014-3835 (AECOM)</org_study_id>
    <nct_id>NCT03289585</nct_id>
  </id_info>
  <brief_title>A National Registry For Patients With Hidradenitis Suppurativa</brief_title>
  <official_title>Development and Maintenance of a National Registry For Patients With Hidradenitis Suppurativa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to get a better understanding of the skin condition, Hidradenitis&#xD;
      Suppurativa, and to find out how the disease affects quality of life. The investigators hope&#xD;
      this information will help improve treatment for this skin condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to get a better understanding of the skin condition, Hidradenitis&#xD;
      Suppurativa, and to find out how the disease affects quality of life. The investigators will&#xD;
      utilize a compilation of validated questionnaires including the Beck Depression Inventory&#xD;
      form, Dermatology Life Quality Index (DLQI), Skindex, SF-36 health survey, the Quality of&#xD;
      Life Enjoyment and Satisfaction Questionnaire- short form (Q-LES-Q-SF) and the&#xD;
      Employment/Productivity Health Economic Questionnaire as well as other relevant clinical&#xD;
      data. The investigators will additionally collect a modified Hidradenitis Suppurativa Lesion,&#xD;
      Area, and Severity Index (HS-LASI) (or other appropriate disease severity score as determined&#xD;
      by the team) from the physician of each enrollee. The investigators hope this information&#xD;
      will help improve treatment for this skin condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">September 6, 2022</completion_date>
  <primary_completion_date type="Actual">September 6, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Skin-related quality of life</measure>
    <time_frame>Baseline</time_frame>
    <description>Quality of life as measured using standardized Dermatology Quality of Life Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence and severity of depression</measure>
    <time_frame>Baseline</time_frame>
    <description>Presence and severity of depression as measured using standardized Beck Depression Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin-related of life</measure>
    <time_frame>Baseline</time_frame>
    <description>Quality of life as measured using standardized SkinDex questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject-reported subject health</measure>
    <time_frame>Baseline</time_frame>
    <description>Subject-reported subject health as measured using the standardized SF-36 questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of enjoyment and satisfaction experienced by subjects in daily functioning.</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Employment and economic productivity</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported employment and economic productivity as measured by a standardized health economic questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>At 6 months</time_frame>
    <description>Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in presence and severity of depression</measure>
    <time_frame>At 6 months</time_frame>
    <description>Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>At 6 months</time_frame>
    <description>Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject-reported subject health</measure>
    <time_frame>At 6 months</time_frame>
    <description>Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning</measure>
    <time_frame>At 6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported employment and economic productivity</measure>
    <time_frame>At 6 months</time_frame>
    <description>Change in self-reported employment and economic productivity as measured by a standardized health economic questionnaire after treatment initiation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <arm_group>
    <arm_group_label>Hidradenitis Suppurativa Cohort</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adults (ages 18-99) with a diagnosis of Hidradenitis Suppurativa&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects 18-99 years of age who have a diagnosis of Hidradenitis Suppurativa (as&#xD;
             deemed by a physician at the Montefiore Hidradenitis Suppurativa Treatment Center)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without a diagnosis of Hidradenitis Suppurativa or under the age of 18&#xD;
&#xD;
          -  Patients who are unable to answer given questions within the 6 surveys&#xD;
&#xD;
          -  Patient who are unable to be clinically evaluated by a Montefiore physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Steven R Cohen, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine/Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.montefiore.org/hidradenitis-suppurativa</url>
    <description>Montefiore Hidradenitis Suppurativa Multispecialty Treatment Center</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hidradenitis Suppurativa</keyword>
  <keyword>Registry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share individual participant data to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03289585
org study id: 2014-3835 (AECOM)
nct id: NCT03289585
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Skin-related quality of life
time frame: Baseline
description: Quality of life as measured using standardized Dermatology Quality of Life Index
measure: Presence and severity of depression
time frame: Baseline
description: Presence and severity of depression as measured using standardized Beck Depression Inventory
measure: Skin-related of life
time frame: Baseline
description: Quality of life as measured using standardized SkinDex questionnaires
measure: Subject-reported subject health
time frame: Baseline
description: Subject-reported subject health as measured using the standardized SF-36 questionnaires
measure: Degree of enjoyment and satisfaction experienced by subjects in daily functioning.
time frame: Baseline
description: 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.
measure: Employment and economic productivity
time frame: Baseline
description: Self-reported employment and economic productivity as measured by a standardized health economic questionnaire
measure: Change in quality of life
time frame: At 6 months
description: Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation
measure: Change in presence and severity of depression
time frame: At 6 months
description: Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation
measure: Change in quality of life
time frame: At 6 months
description: Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation
measure: Change in subject-reported subject health
time frame: At 6 months
description: Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation
measure: Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning
time frame: At 6 months
description: 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
measure: Change in self-reported employment and economic productivity
time frame: At 6 months
description: Change in self-reported employment and economic productivity as measured by a standardized health economic questionnaire after treatment initiation
arm group label: Hidradenitis Suppurativa Cohort
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
last name: Steven R Cohen, MD, MPH
role: Principal Investigator
affiliation: Albert Einstein College of Medicine/Montefiore Medical Center
facility: 
country: United States
url: http://www.montefiore.org/hidradenitis-suppurativa
description: Montefiore Hidradenitis Suppurativa Multispecialty Treatment Center
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: No
ipd description: There is no plan to share individual participant data to other researchers