<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/NCT03288337</url>
  </required_header>
  <id_info>
    <org_study_id>2014-3873</org_study_id>
    <nct_id>NCT03288337</nct_id>
  </id_info>
  <brief_title>Impact of Hidradenitis Suppurativa on Quality of Life Functions</brief_title>
  <official_title>Impact of Hidradenitis Suppurativa on Quality of Life Functions: A Cross-Sectional Analysis of 400 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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 impact of Hidradenitis&#xD;
      Suppurativa (HS) on the quality of life of patients with this condition. Patients with HS&#xD;
      will be asked questions about demographics including gender, age, and ethnicity. They will&#xD;
      also be asked to complete questionnaires to determine how their skin condition affects their&#xD;
      life. Study participation will last for 1 day, with potential for follow-up in the future. We&#xD;
      hope this information will help us improve our 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 impact of the skin condition,&#xD;
      Hidradenitis Suppurativa, on quality of life function of patients. Patients with HS will be&#xD;
      asked questions about demographics including gender, age, and ethnicity. They will also be&#xD;
      asked to complete questionnaires to determine how their skin condition affects their life.&#xD;
      The questionnaires include Beck Depression Inventory form, which gives us information how you&#xD;
      feel about your skin condition and how it changes your mood; Dermatology Life Quality Index&#xD;
      (DLQI), which gives us information about how your skin condition affects your quality of&#xD;
      life; Skindex, which gives us more specific information about how your skin condition affects&#xD;
      your quality of life; SF-36 health survey, which gives us information about your general&#xD;
      health status; the Quality of Life Enjoyment and Satisfaction Questionnaire- short form&#xD;
      (Q-LES-Q-SF), which gives us information on your enjoyment and satisfaction of your life; and&#xD;
      the Employment/Productivity Health Economic Questionnaire, which will give us more&#xD;
      information on your work and school status as well as household income. Study participation&#xD;
      will last for 1 day, with potential for follow-up in the future. Through potential follow up&#xD;
      visits we hope to determine the longitudinal effect of treatment modalities on QoL through&#xD;
      future survey performance of the patient cohort. We hope this information will help us&#xD;
      improve our treatment for this skin condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 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 [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Dermatology-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>Dermatology-related quality 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 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 as measured using standardized Beck Depression Inventory</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>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Hidradenitis Suppurativa Cohort</arm_group_label>
    <description>Patients with HS who are eligible to fill out the series of quality of life questionnaires</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adults (ages 18-99) who have a diagnosis of HS (as deemed by a physician at the&#xD;
        Hidradenitis Suppurativa Treatment Center at Montefiore Medical Center)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of hidradenitis suppurativa&#xD;
&#xD;
          -  Subject age &gt;/= 18 years&#xD;
&#xD;
          -  Able to be evaluated by a Montefiore physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No clinical diagnosis of hidradenitis suppurativa&#xD;
&#xD;
          -  Subject age &lt; 18 years&#xD;
&#xD;
          -  Subject unable to understand or answer provided questionnaires&#xD;
&#xD;
          -  Unable to 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 Cohen, MD. MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Momtefiore 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 Website</description>
  </link>
  <verification_date>January 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 20, 2017</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hidradenitis Suppurativa</keyword>
  <keyword>Quality of Life</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 are no plans 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/NCT03288337
org study id: 2014-3873
nct id: NCT03288337
lead sponsor: 
collaborator: 
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 impact of Hidradenitis
      Suppurativa (HS) on the quality of life of patients with this condition. Patients with HS
      will be asked questions about demographics including gender, age, and ethnicity. They will
      also be asked to complete questionnaires to determine how their skin condition affects their
      life. Study participation will last for 1 day, with potential for follow-up in the future. We
      hope this information will help us improve our treatment for this skin condition.
The goal of this study is to get a better understanding of the impact of the skin condition,
      Hidradenitis Suppurativa, on quality of life function of patients. Patients with HS will be
      asked questions about demographics including gender, age, and ethnicity. They will also be
      asked to complete questionnaires to determine how their skin condition affects their life.
      The questionnaires include Beck Depression Inventory form, which gives us information how you
      feel about your skin condition and how it changes your mood; Dermatology Life Quality Index
      (DLQI), which gives us information about how your skin condition affects your quality of
      life; Skindex, which gives us more specific information about how your skin condition affects
      your quality of life; SF-36 health survey, which gives us information about your general
      health status; the Quality of Life Enjoyment and Satisfaction Questionnaire- short form
      (Q-LES-Q-SF), which gives us information on your enjoyment and satisfaction of your life; and
      the Employment/Productivity Health Economic Questionnaire, which will give us more
      information on your work and school status as well as household income. Study participation
      will last for 1 day, with potential for follow-up in the future. Through potential follow up
      visits we hope to determine the longitudinal effect of treatment modalities on QoL through
      future survey performance of the patient cohort. We hope this information will help us
      improve our treatment for this skin condition.
observational model: Cohort
time perspective: Cross-Sectional
measure: Dermatology-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: Dermatology-related quality 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 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 as measured using standardized Beck Depression Inventory
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 HS who are eligible to fill out the series of quality of life questionnaires
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
last name: Steven Cohen, MD. MPH
role: Principal Investigator
affiliation: Momtefiore Medical Center
facility: 
country: United States
url: http://www.montefiore.org/hidradenitis-suppurativa
description: Montefiore Hidradenitis Suppurativa Website
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: No
ipd description: There are no plans to share individual participant data to other researchers