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Impact of Hidradenitis Suppurativa on Quality of Life Functions

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ClinicalTrials.gov Identifier: NCT03288337
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Sponsor:
Collaborator:
AbbVie
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 impact of the skin condition, Hidradenitis Suppurativa, on quality of life function 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
Hidradenitits Suppurativa Quality of Life

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 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. 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 Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Impact of Hidradenitis Suppurativa on Quality of Life Functions: A Cross-Sectional Analysis of 400 Patients
Actual Study Start Date : April 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Hidradenitits Suppurativa Cohort
Patients with HS who are eligible to fill out the series of quality of life questionnaires



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 as measured using standardized Beck Depression Inventory [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults (ages 18-99) who have a diagnosis of HS (as deemed by a physician)
Criteria

Inclusion Criteria:

  • Clinical diagnosis of hidradenitis suppurativa
  • Subject age >/= 18 years

Exclusion Criteria:

  • No clinical diagnosis of hidradenitis suppurativa
  • Subject age < 18 years
  • Subject unable to understand or answer provided questionnaires

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): NCT03288337


Contacts
Contact: Steven 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
The 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
AbbVie

Additional Information:
Responsible Party: Steven R Cohen, Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03288337     History of Changes
Other Study ID Numbers: 2014-3873
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans 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
Quality of Life

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