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Completed

NCT Number: NCT03288337

Impact of Hidradenitis Suppurativa on Quality of Life Functions

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dermatology-related 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. Dermatology-related 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • AbbVie

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2017
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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