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Understanding Evaluation of Patient Information Sheets by User Testing Method

NCT03155334 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-01-16

No results posted yet for this study

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.

Conditions

  • MS (Multiple Sclerosis)

Interventions

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.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Fondazione Italiana Sclerosi Multipla

    lead OTHER

Principal Investigators

  • Mario Alberto Battaglia, Prof. · Fondazione Italiana Sclerosi Multipla (FISM), Genova , (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-02-20
Completion
2018-12-30

Countries

  • Italy
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03155334 on ClinicalTrials.gov