Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 8:54 PM
Study NCT ID:
NCT03155334
Status:
UNKNOWN
Last Update Posted:
2018-01-16
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Evaluation of Patient Information Sheets by User Testing Method
Sponsor:
Fondazione Italiana Sclerosi Multipla
Organization:
Study Overview
Official Title:
Understanding Evaluation of Patient Information Sheets of Two Multiple Sclerosis Studies Through User Testing Method in a Randomized, Open Label, Crossover Design
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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):
* 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; Then the revised document is tested again with a second cohort and this iterative process continues until all issues with the document are resolved. However, a methodological issue not yet explored is whether the UT could be used to compare two different PISs, in order to elucidate aspects that could be involved in improving or worsening the understanding of a PIS.
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.
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):
* 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; Then the revised document is tested again with a second cohort and this iterative process continues until all issues with the document are resolved. However, a methodological issue not yet explored is whether the UT could be used to compare two different PISs, in order to elucidate aspects that could be involved in improving or worsening the understanding of a PIS.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: