Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact

A Comparative Retrospective Study Between Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact

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

Study Overview

• Status: Unknown
• Conditions: Psoriasis; Hidradenitis
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Eva Vilarrasa Rull, Dr.; Phone Number: +34935537007; Email: evilarrasa@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Universitat Autonoma de Barcelona

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (ANTICIPATED): April 1, 2017
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Psoriasis; Quality of life; Hidradenitis; Psychological impact
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Hidradenitis
• Other Study ID Numbers: IIBSP-PSI-2016-71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO