A National Registry For Patients With Hidradenitis Suppurativa

Sponsor

Montefiore Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03289585

Collaborator

(none)

400

Enrollment

Location

90.5

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Development and Maintenance of a National Registry For Patients With Hidradenitis Suppurativa

Actual Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Feb 14, 2023

Anticipated Study Completion Date :

Feb 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Hidradenitis Suppurativa Cohort Patients with Hidradenitis Suppurativa (ages 18-99 years old) will be asked to complete a series of questionnaires on how Hidradenitis Suppurativa impacts quality of life.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

Montefiore Medical Center

Investigators

Principal Investigator: Steven R Cohen, MD, MPH, Albert Einstein College of Medicine/Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Montefiore Hidradenitis Suppurativa Multispecialty Treatment Center

Publications

None provided.

Responsible Party:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT03289585

Other Study ID Numbers:

2014-3835 SRC

First Posted:

Sep 21, 2017

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Montefiore Medical Center

Hidradenitis Suppurativa

Registry

Additional relevant MeSH terms:

Hidradenitis Suppurativa

Hidradenitis

Study Results

No Results Posted as of Mar 8, 2022