MS (Multiple Sclerosis) Clinical Trial
Official title:
Understanding Evaluation of Patient Information Sheets of Two Multiple Sclerosis Studies Through User Testing Method in a Randomized, Open Label, Crossover Design
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):
- 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04530955 -
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
|
N/A | |
Completed |
NCT05435404 -
Qualitative Study Patient & Physician Experiences Botox COVID-19
|
||
Completed |
NCT04379661 -
SUNLIGHT Study: Online Support Groups for MS to Address COVID-19
|
N/A | |
Recruiting |
NCT05912595 -
EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2)
|
N/A | |
Completed |
NCT06199219 -
Ex-Plissit Model Based Counseling on Sexual Function and Sexual Satisfaction
|
N/A | |
Not yet recruiting |
NCT04822623 -
Imaging Evaluation of Central Nervous Autoimmune Diseases
|
||
Completed |
NCT04095377 -
Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.
|
||
Recruiting |
NCT05857280 -
EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2)
|
N/A | |
Completed |
NCT02490943 -
A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS
|
N/A | |
Active, not recruiting |
NCT05991297 -
Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT01628276 -
Brain Functional Connectivity Changes Following Cognitive Rehabilitation in Multiple Sclerosis: an fMRI Study
|
N/A | |
Completed |
NCT00872053 -
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
|
Phase 1/Phase 2 |