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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 : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Steven R Cohen, Montefiore Medical Center

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.

Condition or disease
Hidradenitis Suppurativa

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. Through internet groups and the American Academy of Dermatology, the investigators propose to enroll greater than 200 enrollees in the first two years of this project. The investigatorswill 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 investigatorshope this information will help improve treatment for this skin condition.

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Maintenance of a National Registry For Patients With Hidradenitis Suppurativa
Actual Study Start Date : August 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort
HS Cohort
Patients with HS (ages 18-99 years old) will be asked to complete a series of questionnaires on how HS impacts quality of life.



Primary Outcome Measures :
  1. Quality of life [ Time Frame: Baseline ]
    Quality of life as measured using standardized Dermatology Quality of Life Index

  2. Presence and severity of depression [ Time Frame: Baseline ]
    Presence and severity of depression as measured using standardized Beck Depression Inventory

  3. Quality of life [ Time Frame: Baseline ]
    Quality of life as measured using standardized SkinDex questionnaires

  4. Subject-reported subject health [ Time Frame: Baseline ]
    Subject-reported subject health as measured using standardized SF-36 questionnaires

  5. 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.

  6. Employment and economic productivity [ Time Frame: Baseline ]
    Self-reported employment and economic productivity as measured by a standardized health economic questionnaire


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in quality of life [ Time Frame: At 6 months ]
    Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults (ages 18-99) with a diagnosis of HS
Criteria

Inclusion Criteria:

  • Subjects 18-99 years of age who have a diagnosis of HS (as deemed by a physician)

Exclusion Criteria:

  • Patients without a Diagnosis of HS or under the age of 18
  • Patients who are unable to answer given questions within the 6 surveys

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289585


Contacts
Contact: Steve R Cohen, MD, MPH 7189208470 srcohen@montefiore.org
Contact: Anthony Guzman, MD 7189208470 dermpharmeinstein@gmail.com

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Steven R Cohen, MD, MPH    718-920-8470    srcohen@montefiore.org   
Contact: Anthony Guzman, MD    7189208470    dermpharmeinstein@gmail.com   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Steven R Cohen, MD, MPH Albert Einstein College of Medicine/ Montefiore Medical Center

Additional Information:
Responsible Party: Steven R Cohen, Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03289585     History of Changes
Other Study ID Numbers: 2014-3835 SRC
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data to other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Steven R Cohen, Montefiore Medical Center:
Hidradenitis Suppurativa
Registry

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration