Impact of Hidradenitis Suppurativa on Quality of Life Functions

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288337
• Other study ID #: 2014-3873
• Status: Completed
• Start date: April 2015
• Est. completion date: September 6, 2022

Study information

• Verified date: January 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Quality of Life

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermatology-related quality of life	Quality of life as measured using standardized Dermatology Quality of Life Index	Baseline
Primary	Presence and severity of depression	Presence and severity of depression as measured using standardized Beck Depression Inventory	Baseline
Primary	Dermatology-related quality of life	Quality of life as measured using standardized SkinDex questionnaires	Baseline
Primary	Subject-reported subject health	Subject-reported subject health as measured using standardized SF-36 questionnaires	Baseline
Primary	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
Primary	Employment and economic productivity	Self-reported employment and economic productivity as measured by a standardized health economic questionnaire	Baseline
Secondary	Change in quality of life	Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation	At 6 months
Secondary	Change in presence and severity of depression as measured using standardized Beck Depression Inventory	Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation	At 6 months
Secondary	Change in quality of life	Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation	At 6 months
Secondary	Change in subject-reported subject health	Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation	At 6 months
Secondary	Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning	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
Secondary	Change in self-reported employment and economic productivity	Change in self-reported employment and economic productivity as measured by a standardized health economic questionnaire after treatment initiation	At 6 months

External Links

•   Montefiore Hidradenitis Suppurativa Website