NCT03288337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

7.4 years

First QC Date

September 11, 2017

Last Update Submit

January 18, 2023

Conditions

Keywords

Hidradenitis SuppurativaQuality of Life

Outcome Measures

Primary Outcomes (6)

  • Dermatology-related quality of life

    Quality of life as measured using standardized Dermatology Quality of Life Index

    Baseline

  • Presence and severity of depression

    Presence and severity of depression as measured using standardized Beck Depression Inventory

    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

  • 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

Secondary Outcomes (6)

  • Change in quality of life

    At 6 months

  • Change in presence and severity of depression as measured using standardized Beck Depression Inventory

    At 6 months

  • Change in quality of life

    At 6 months

  • Change in subject-reported subject health

    At 6 months

  • Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning

    At 6 months

  • +1 more secondary outcomes

Study Arms (1)

Hidradenitis Suppurativa Cohort

Patients with HS who are eligible to fill out the series of quality of life questionnaires

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Clinical diagnosis of hidradenitis suppurativa
  • Subject age \>/= 18 years
  • Able to be evaluated by a Montefiore physician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Links

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Officials

  • Steven Cohen, MD. MPH

    Momtefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 20, 2017

Study Start

April 1, 2015

Primary Completion

September 6, 2022

Study Completion

September 6, 2022

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

There are no plans to share individual participant data to other researchers

Locations