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Trial record 5 of 90 for:    hidradenitis suppurativa

Hidradenitis Suppurativa Mail Survey

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ClinicalTrials.gov Identifier: NCT03572738
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2018
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Hidradenitis Suppurativa (HS), also known as "acne inversa," is a chronic dermatologic disease affecting apocrine gland-bearing areas and presenting with symptoms ranging from pustules and inflammatory nodules to draining sinuses, abscesses, and fistulae. The pain and odorous lesions associated with HS contribute to its heightened impact on quality of life in comparison to other diseases; it has been described as "one of the most distressing conditions observed in dermatology." Though it is clear that HS has a significant impact on quality of life, how this manifests remains poorly characterized. The aim of this study is to characterize the quality of life impact of HS and to validate a tool for patients to self-assess the severity of their condition.

Condition or disease
Hidradenitis Suppurativa

Detailed Description:
Running a comprehensive study and asking patients what challenges they encounter in their daily lives can shed light on the ways in which HS causes quality of life impairment. In this study, the study team aims to identify the following: problems faced by patients with HS, the rate of depression, the rate of stigmatization, the rate of fear of being accepted in society, treatments that patients have tried (and which treatments seem to have worked best), the rate of alternative treatment use, and the correlation of these factors with the severity of disease.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hidradenitis Suppurativa Mail Survey
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with HS
The set of all Hidradenitis Suppurativa patients (ICD-10 code: L73.2) who visited Wake Forest Baptist Medical Center's dermatology clinic during the last 5 years will either be recruited in person or be mailed the HS Severity Self-Assessment tool and a survey about their demographics, symptoms, treatments, psychological aspects, and lifestyle.



Primary Outcome Measures :
  1. Comparison of self-assessed severity to physician-assessed severity of HS [ Time Frame: 1 day ]
    Participants will be administered a 2-page survey with photographs of HS in varying degrees of severity (Hidradenitis Suppurativa Self-Assessment tool, or HSSA) and asked to check the photo(s) that represent their condition now and when it was the worst it has ever been. The photos correspond with severity levels 0 (no disease), 1, 2, and 3 according to the Hurley Staging system (a commonly used system to evaluate severity of HS). Physicians will also assess the Hurley severity of disease when they see the patient. Agreement between physician severity assessment and self assessment will be measured.

  2. Test-retest reliability of self-assessed severity of HS [ Time Frame: 1 day ]
    Participants will be administered a 2-page survey with photographs of HS in varying degrees of severity and asked to check the photo(s) that represent their condition now and when it was the worst it has ever been. The photos correspond with severity levels 0 (no disease), 1, 2, and 3 according to the Hurley Staging system (a commonly used system to evaluate severity of HS). At least 30 minutes later, participant's will re-do the HSSA. Agreement between the original and second response will be assessed to establish test-retest reliability of the tool.

  3. Ability of HSSA to detect changes in disease severity over time [ Time Frame: 1 day ]
    For those patients who are recruited in person, when they come back to the clinic for follow-up, the HSSA will be administered again. The physician will also provide an assessment of severity. These will be compared to the original physician assessment and HSSA result to determine the ability of the HSSA to detect changes in disease severity over time.


Secondary Outcome Measures :
  1. Quality of life as measured by DLQI [ Time Frame: 1 day ]
    Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The Dermatology Life Quality Index (Finlay and Khan) is one of these metrics; it is a standardized questionnaire assessing a patient's quality of life. This will be scored according to standard guidelines and assessed in all subjects. The scores range from 0 to 30, with a higher score indicating higher quality of life impairment. Further analysis may be done to group quality of life by severity and baseline characteristics.

  2. Quality of life as measured by HiSQoL [ Time Frame: 1 day ]
    Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The Hidradenitis Suppurativa Quality of Life survey (McLellan, Sisic, Oon, Tan) is one of these metrics; it is a standardized questionnaire assessing a patient's quality of life. This will be scored according to standard guidelines and assessed in all subjects. Each factor is rated on a scale from 0-4, 0 meaning HS does not influence that factor at all, and 4 meaning the factor is affected greatly by HS. Thus, higher numbers correlate with higher quality of life impact. Further analysis may be done to group quality of life by severity and baseline characteristics.

  3. Quality of life as measured by RAND-36 [ Time Frame: 1 day ]
    Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The RAND-36 is one of these metrics; it is a standardized questionnaire assessing a patient's quality of life. This will be scored according to standard guidelines and assessed in all subjects. In terms of scoring, questions are grouped into broader categories: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, and health change. Each group is assigned a percentage based on responses (0-100), and a higher percentage signifies better quality of life for each category (the greatest is 100%). Further analysis may be done to group quality of life by severity and baseline characteristics.

  4. Depression as measured by PHQ-9 [ Time Frame: 1 day ]
    Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The PHQ-9 is one of these metrics; it is a standardized questionnaire assessing severity of depression. This will be scored according to standard guidelines and assessed in all subjects. For each of the 9 questions, scores can range from 0-3, 3 being the worst (experiencing the symptom nearly every day). These numbers are summed. A score of 0-4 signifies no depression, 5-9 signifies mild depression, 10-14 signifies moderate depression, 15-19 signifies moderately severe depression, and 20-27 signifies severe depression. Further analysis may be done to group depression status by severity of HS and baseline characteristics.

  5. Fear of Negative Evaluation [ Time Frame: 1 day ]
    Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The Brief Fear of Negative Evaluation survey (Leary) is one of these metrics; it is a standardized questionnaire assessing social anxiety. This will be scored according to standard guidelines and assessed in all subjects. The score for each question ranges from 0-5, and 4/12 items are reverse coded. Higher scores indicated higher levels of social anxiety. Further analysis may be done to group scores by severity and baseline characteristics.

  6. Emotional Stability as measured by PANAS (Positive and Negative Affect Schedule) [ Time Frame: 1 day ]
    Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The PANAS is one of these metrics; it is a standardized questionnaire assessing levels of positive and negative affect. This will be scored according to standard guidelines and assessed in all subjects. The PANAS consists of 20 questions. 10 questions measure positive affect, with scores ranging from 10-50 and higher scores indicating greater positive affect. Similarly, 10 questions measure negative affect, with scores ranging from 10-50, with smaller scores indicating lower levels of negative affect. Further analysis may be done to group scores by severity and baseline characteristics.

  7. Stigmatization as measured by an adaptation of Ginsburg and Link Feelings of Stigmatization [ Time Frame: 1 day ]
    Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The Feelings of Stigmatization survey (adapted from Ginsburg and Link) is one of these metrics; it is a standardized questionnaire assessing stigma associated with disease. This will be scored according to standard guidelines and assessed in all subjects. The adapted survey contains 31 questions asking about stigmatization. Aside from the reverse coded questions, higher scores indicate greater levels of stigmatization (for each question, the score ranges from strongly agree to strongly disagree). Further analysis may be done to group scores by severity and baseline characteristics.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subset of all Hidradenitis Suppurativa patients who visited the Wake Forest Baptist Medical Center's dermatology clinic during last 5 years will be mailed questionnaires and recruited in clinic.
Criteria

Inclusion Criteria:

  • Patients diagnosed with Hidradenitis Suppurativa by a dermatologist at Wake Forest Baptist Medical Center's dermatology clinic.
  • Patients 18 years of age or older

Exclusion Criteria:

  • Patients younger than 18 years of age
  • Any patient who does not have a mailing address on file

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572738


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27517
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Steven R. Feldman, M.D., Ph.D. Wake Forest University Health Sciences

Publications:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03572738     History of Changes
Other Study ID Numbers: IRB00049730
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
acne inversa
HS
Verneuil's Disease
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration