Impact of Hidradenitis Suppurativa on Quality of Life Functions

Impact of Hidradenitis Suppurativa on Quality of Life Functions: A Cross-Sectional Analysis of 400 Patients

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Hidradenitis Suppurativa

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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 at the Hidradenitis Suppurativa Treatment Center at Montefiore Medical Center)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence and severity of depression	Presence and severity of depression as measured using standardized Beck Depression Inventory	Baseline
Degree of enjoyment and satisfaction experienced by subjects in daily functioning.	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.	Baseline
Employment and economic productivity	Self-reported employment and economic productivity as measured by a standardized health economic questionnaire	Baseline
Dermatology-related quality of life	Quality of life as measured using standardized Dermatology Quality of Life Index	Baseline
Dermatology-related quality of life	Quality of life as measured using standardized SkinDex questionnaires	Baseline
Subject-reported subject health	Subject-reported subject health as measured using standardized SF-36 questionnaires	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation	At 6 months
Change in quality of life	Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation	At 6 months
Change in subject-reported subject health	Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation	At 6 months
Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning	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	At 6 months
Change in self-reported employment and economic productivity	Change in self-reported employment and economic productivity as measured by a standardized health economic questionnaire after treatment initiation	At 6 months
Change in presence and severity of depression as measured using standardized Beck Depression Inventory	Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation	At 6 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: AbbVie
• Investigators: Principal Investigator: Steven Cohen, MD. MPH, Momtefiore Medical Center

Publications and helpful links

Helpful Links

• Montefiore Hidradenitis Suppurativa Website

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Hidradenitis Suppurativa
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: 2014-3873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There are no plans to share individual participant data to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No