An interventional study of PIS User Testing in MS (Multiple Sclerosis), sponsored by Fondazione Italiana Sclerosi Multipla. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-16.
Sponsored by Fondazione Italiana Sclerosi Multipla · Not applicable, Interventional, and Basic science
The purpose of this randomized, open label, crossover, single site study is to compare the PISs of two Multiple Sclerosis clinical trials to elucidate potential aspects of the given written information that could impact on the smooth running of the studies.
The participation to a clinical trial is based on two forms of information: the spoken information, usually given by a clinician during the enrolment meeting, and the written information, reported on the Participant Information Sheet (PIS). Numerous studies performed to improve and enhance informed consent, have used different methods to evaluate the quality of the given information such as: interview, checklist, questionnaire, readability formulae. Even if these tools can be useful, they show evident limits in detecting the real efficacy of the proposed consent form in terms of the patient's comprehension.
User Testing (UT) is a method originally developed in the 1990 in Australia, to assess how a text about medicinal products performs with its intended users and not just its content.
Generally, the UT is based on an iterative 4-step process in a cohort of participants (the target group):
UT has been recently used to evaluate the PIS belonging to phase I and phase III clinical trials (CT) in Myeloid Leukemia, immunomodulatory therapy and for poor responders in vitro fertilization. To date, in no case the UT method has been tested in patients affected by chronic disease like Multiple Sclerosis (MS).
We want to apply the UT approach to highlight the critical issues and communication difficulties present in PISs used in MS clinical trials.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Fondazione Italiana Sclerosi Multipla is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: PwMS (60%) and Caregivers (40%):
for PwMS:
Exclusion Criteria:
Subjects with prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases - PIS User Testing
Other: PIS User Testing
Subjects suffering from Brain venous drainage exploited against Multiple Sclerosis - PIS User Testing
Other: PIS User Testing
PIS User Testing based on an iterative 4-step process in a cohort of participants (the target group): * individual reading of the text; * individual questionnaire for a quantitative and qualitative evaluation; * a brief semi-structured interview to each participant; * a text revision to address any problems identified from participant feedback.
percentage of found and understood-if-found items
percentage
Time frame: 1 day
understanding of the text expressed by subject
Visual Analogue Scale (VAS)
Time frame: 1 day
Plan to share: Yes
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Fondazione Italiana Sclerosi Multipla