NCT02999698

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

December 19, 2016

Last Update Submit

December 21, 2016

Conditions

PsoriasisHidradenitis

Keywords

PsoriasisHidradenitisPsychological impactQuality of life

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Psoriasis Area Severity Index (PASI)

    1 day

  • Static Physician's Global Assessment (sPGA)

    1 day

  • Hurley's staging system

    1 day

  • Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA)

    1 day

Study Arms (2)

Psoriasis Group

Patients with psoriasis complete the questionnaires for psychological impact.

Other: Observational

Hidradenitis Suppurativa Group

Patients with hidradenitis suppurativa complete the questionnaires for psychological impact.

Other: Observational

Interventions

ObservationalOTHER

Observational

Hidradenitis Suppurativa GroupPsoriasis Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PsoriasisHidradenitis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSweat Gland Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Esther Margarit de Miguel, Msc

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

  • Antoni Font Guiteras, PhD

    Universitat Autonoma de Barcelona

    STUDY DIRECTOR

Central Study Contacts

Esther Margarit de Miguel, Msc

CONTACT

+34696617013emargarit@santpau.cat

Eva Vilarrasa Rull, Dr.

CONTACT

+34935537007evilarrasa@santpau.cat

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 21, 2016

Study Start

February 1, 2017

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

December 22, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share