Clinical trial NCT03289585: A National Registry For Patients With Hidradenitis Suppurativa
Official title: Development and Maintenance of a National Registry For Patients With Hidradenitis Suppurativa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Registry
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults (ages 18-99) with a diagnosis of Hidradenitis Suppurativa

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.

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. The investigators will 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 investigators hope this information will help improve treatment for this skin condition.

Eligibility criteria: Inclusion Criteria:

* Subjects 18-99 years of age who have a diagnosis of Hidradenitis Suppurativa (as deemed by a physician at the Montefiore Hidradenitis Suppurativa Treatment Center)

Exclusion Criteria:

* Patients without a diagnosis of Hidradenitis Suppurativa or under the age of 18
* Patients who are unable to answer given questions within the 6 surveys
* Patient who are unable to be clinically evaluated by a Montefiore physician

Primary outcomes:
measure: Skin-related quality of life
timeFrame: Baseline
measure: Presence and severity of depression
timeFrame: Baseline
measure: Skin-related 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
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: Albert Einstein College of Medicine Montefiore Medical Center
name: Steven R Cohen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: