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Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact

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ClinicalTrials.gov Identifier: NCT02999698
Recruitment Status : Unknown
Verified December 2016 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Not yet recruiting
First Posted : December 21, 2016
Last Update Posted : December 22, 2016
Sponsor:
Collaborator:
Universitat Autonoma de Barcelona
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis suppurativa on patients, in order to compare both pathologies.

Condition or disease Intervention/treatment
Psoriasis Hidradenitis Other: Observational

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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Retrospective
Official Title: A Comparative Retrospective Study Between Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact
Study Start Date : February 2017
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Psoriasis Group
Patients with psoriasis complete the questionnaires for psychological impact.
Other: Observational
Observational

Hidradenitis Suppurativa Group
Patients with hidradenitis suppurativa complete the questionnaires for psychological impact.
Other: Observational
Observational




Primary Outcome Measures :
  1. Dermatology Quality of Life Index (DLQI) [ Time Frame: 1 day ]
    The Dermatology Life Quality Index or DLQI, developed in 1994, was the first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.

  2. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 day ]
    Hospital Anxiety and Depression Scale (HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.

  3. Perceived Stress Scale (PSS) [ Time Frame: 1 day ]
    Perceived Stress Scale (PSS) was originally developed by Cohen (1983) and this scale is a self-report instrument that evaluates the level of stress perceived during the last month. The scale consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = Every now and then, 3 = often, 4 = very often). The score obtained indicates that a higher score corresponds to a higher level of perceived stress.

  4. The Holmes and Rahe stress scale [ Time Frame: 1 day ]
    The Holmes and Rahe stress scale is a list of 43 stressful life events that can contribute to illness.


Secondary Outcome Measures :
  1. Psoriasis Area Severity Index (PASI) [ Time Frame: 1 day ]
    The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area.

  2. Static Physician's Global Assessment (sPGA) [ Time Frame: 1 day ]
    The PGA is a 5 point ordinal rating ranging from "clear" to "very severe psoriasis".

  3. Hurley's staging system [ Time Frame: 1 day ]
    Hurley separated patients into three groups based largely on the presence and extent of cicatrization and sinuses. It has been used as a basis for clinical trials in the past and is a useful basis to approach therapy for patients. These three stages are based on Hurley's staging system, which is simple and relies on the subjective extent of the diseased tissue the patient has. Hurley's three stages of hidradenitis suppurativa.

  4. Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) [ Time Frame: 1 day ]
    The six-point Physician Global Assessment (PGA) ranges from clear to very severe. It is used in clinical trials to measure clinical improvement in inflammatory nodules, abscesses and draining fistulae



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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with hidradenitis suppurativa or psoriasis who have completed the questionnaires for psychological impact in the Hospital de la Santa Creu and Sant Pau, Barcelona.
Criteria

Inclusion Criteria:

  • Men and women at least 18 years old at the time of selection.
  • Subjects diagnosed with psoriasis or hidradenitis suppurativa
  • Subjects who had completed the questionnaires for psychological impact.
  • Patients should be able to understand and communicate with the investigator.

Exclusion Criteria:

  • Subjects suffering from a serious concomitant illness.
  • Subjects with a mental illness.
  • Subjects who are performing psychiatric treatment.
  • Patients who have alcohol dependence or drug abuse.
  • Subjects that present legal incapacity or limited legal capacity.
  • Subjects presenting illiteracy or language barriers.

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): NCT02999698


Contacts
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Contact: Esther Margarit de Miguel, Msc +34696617013 emargarit@santpau.cat
Contact: Eva Vilarrasa Rull, Dr. +34935537007 evilarrasa@santpau.cat

Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Universitat Autonoma de Barcelona
Investigators
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Principal Investigator: Esther Margarit de Miguel, Msc Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Director: Antoni Font Guiteras, PhD Universitat Autonoma de Barcelona

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02999698     History of Changes
Other Study ID Numbers: IIBSP-PSI-2016-71
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Psoriasis
Hidradenitis
Psychological impact
Quality of life
Additional relevant MeSH terms:
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Psoriasis
Hidradenitis
Skin Diseases, Papulosquamous
Skin Diseases
Sweat Gland Diseases