Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01139918
Brief Summary:
This exploratory study will be used to identify questions that will be part of a new QoL questionnaire for patients with psoriasis and psoriatic arthritis and to determine the sample size needed for its validation. The new questionnaire will be a global QoL questionnaire which will take into account the impact of both psoriasis and psoriatic arthritis on QoL.
STUDY OBJECTIVES
* To evaluate the influence of psoriasis and psoriatic arthritis on patient's answers to QoL questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36.
* To identify an equal number of questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36 where answers are mostly influenced either by psoriatic arthritis or by psoriasis.
Detailed Description:
This study will recruit three cohorts of 40 patients each: moderate psoriatic arthritis and moderate psoriasis, mild psoriatic arthritis and moderate psoriasis, moderate psoriatic arthritis and mild psoriasis. Eligible patients will fill the following questionnaires: Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire (HAQ), EQ-5D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) and 36-Item Short Form Health Survey Questionnaire (SF-36). In addition, each patient will be asked on a 4 point Likert scale how much their answer to each question is related to the impact of their skin disease or their psoriatic arthritis.
Study:
NCT01139918
Study Brief:
Protocol Section:
NCT01139918