Impact of Hidradenitis Suppurativa on Quality of Life Functions

Sponsor
Montefiore Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03288337
Collaborator
AbbVie (Industry)
400
1
99
4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Impact of Hidradenitis Suppurativa on Quality of Life Functions: A Cross-Sectional Analysis of 400 Patients
    Actual Study Start Date :
    Apr 1, 2015
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Hidradenitis Suppurativa Cohort

    Patients with HS who are eligible to fill out the series of quality of life questionnaires

    Outcome Measures

    Primary Outcome Measures

    1. Dermatology-related quality of life [Baseline]

      Quality of life as measured using standardized Dermatology Quality of Life Index

    2. Presence and severity of depression [Baseline]

      Presence and severity of depression as measured using standardized Beck Depression Inventory

    3. Dermatology-related quality of life [Baseline]

      Quality of life as measured using standardized SkinDex questionnaires

    4. Subject-reported subject health [Baseline]

      Subject-reported subject health as measured using standardized SF-36 questionnaires

    5. Degree of enjoyment and satisfaction experienced by subjects in daily functioning. [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.

    6. Employment and economic productivity [Baseline]

      Self-reported employment and economic productivity as measured by a standardized health economic questionnaire

    Secondary Outcome Measures

    1. Change in quality of life [At 6 months]

      Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation

    2. Change in presence and severity of depression as measured using standardized Beck Depression Inventory [At 6 months]

      Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation

    3. Change in quality of life [At 6 months]

      Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation

    4. Change in subject-reported subject health [At 6 months]

      Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation

    5. Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning [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

    6. Change in self-reported employment and economic productivity [At 6 months]

      Change in self-reported employment and economic productivity as measured by a standardized health economic questionnaire after treatment initiation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Clinical diagnosis of hidradenitis suppurativa

    • Subject age >/= 18 years

    • Able to be evaluated by a Montefiore physician

    Exclusion Criteria:
    • No clinical diagnosis of hidradenitis suppurativa

    • Subject age < 18 years

    • Subject unable to understand or answer provided questionnaires

    • Unable to evaluated by a Montefiore physician

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montefiore Medical Center Bronx New York United States 10467

    Sponsors and Collaborators

    • Montefiore Medical Center
    • AbbVie

    Investigators

    • Principal Investigator: Steven Cohen, MD. MPH, Momtefiore Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT03288337
    Other Study ID Numbers:
    • 2014-3873
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Montefiore Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 6, 2022