Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03155334
Study type Interventional
Source Fondazione Italiana Sclerosi Multipla
Contact Dionisio Barattini, MD
Phone +393355437574
Email barattini@operacro.ro
Status Recruiting
Phase N/A
Start date January 31, 2017
Completion date December 30, 2018

See also
  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