Impact of Hidradenitis Suppurativa on Quality of Life Functions

January 18, 2023 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Hidradenitis Suppurativa Cohort
Patients with HS who are eligible to fill out the series of quality of life questionnaires

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence and severity of depression
Time Frame: Baseline
Presence and severity of depression as measured using standardized Beck Depression Inventory
Baseline
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.
Baseline
Employment and economic productivity
Time Frame: Baseline
Self-reported employment and economic productivity as measured by a standardized health economic questionnaire
Baseline
Dermatology-related quality of life
Time Frame: Baseline
Quality of life as measured using standardized Dermatology Quality of Life Index
Baseline
Dermatology-related quality of life
Time Frame: Baseline
Quality of life as measured using standardized SkinDex questionnaires
Baseline
Subject-reported subject health
Time Frame: Baseline
Subject-reported subject health as measured using standardized SF-36 questionnaires
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At 6 months
Change in quality of life
Time Frame: At 6 months
Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation
At 6 months
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
At 6 months
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
At 6 months
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
At 6 months
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
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montefiore Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven Cohen, MD. MPH, Momtefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-3873

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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