Clinical trial NCT03288337: Impact of Hidradenitis Suppurativa on Quality of Life Functions
Official title: Impact of Hidradenitis Suppurativa on Quality of Life Functions: A Cross-Sectional Analysis of 400 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Quality of Life
Keywords: Hidradenitis Suppurativa
Quality of Life
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-09-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dermatology-related quality of life
timeFrame: Baseline
measure: Presence and severity of depression
timeFrame: Baseline
measure: Dermatology-related quality of life
timeFrame: Baseline
measure: Subject-reported subject health
timeFrame: Baseline
measure: Degree of enjoyment and satisfaction experienced by subjects in daily functioning.
timeFrame: Baseline
measure: Employment and economic productivity
timeFrame: Baseline
Secondary outcomes:
measure: Change in quality of life
timeFrame: At 6 months
measure: Change in presence and severity of depression as measured using standardized Beck Depression Inventory
timeFrame: At 6 months
measure: Change in quality of life
timeFrame: At 6 months
measure: Change in subject-reported subject health
timeFrame: At 6 months
measure: Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning
timeFrame: At 6 months
measure: Change in self-reported employment and economic productivity
timeFrame: At 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Momtefiore Medical Center
name: Steven Cohen, MD. MPH
role: PRINCIPAL_INVESTIGATOR
References: