Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact

• Conditions: Hidradenitis; Psoriasis
• Interventions: Other: Observational

• Registration Number: NCT02999698
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-21
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22
• Study Start: 2017-02
• Primary Completion: 2017-04
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psoriasis Group	Observational	Patients with psoriasis complete the questionnaires for psychological impact.
Hidradenitis Suppurativa Group	Observational	Patients with hidradenitis suppurativa complete the questionnaires for psychological impact.

Primary Outcome Measures

Name	Time	Method
The Holmes and Rahe stress scale	1 day	The Holmes and Rahe stress scale is a list of 43 stressful life events that can contribute to illness.
Dermatology Quality of Life Index (DLQI)	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.
Hospital Anxiety and Depression Scale (HADS)	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.
Perceived Stress Scale (PSS)	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.

Secondary Outcome Measures

Name	Time	Method
Static Physician's Global Assessment (sPGA)	1 day	The PGA is a 5 point ordinal rating ranging from "clear" to "very severe psoriasis".
Psoriasis Area Severity Index (PASI)	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.
Hurley's staging system	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.
Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA)	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