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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03155334 |
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Date of registration:
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15/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Understanding Evaluation of Patient Information Sheets by User Testing Method
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Scientific title:
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Understanding Evaluation of Patient Information Sheets of Two Multiple Sclerosis Studies Through User Testing Method in a Randomized, Open Label, Crossover Design |
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Date of first enrolment:
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January 31, 2017 |
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Target sample size:
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100 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03155334 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Romania
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Contacts
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Name:
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Dionisio Barattini, MD |
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Address:
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Telephone:
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+393355437574 |
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Email:
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barattini@operacro.ro |
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Affiliation:
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Name:
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Mario Alberto Battaglia, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fondazione Italiana Sclerosi Multipla (FISM), Genova , (Italy) |
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Key inclusion & exclusion criteria
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Inclusion Criteria: PwMS (60%) and Caregivers (40%):
for PwMS:
- 18 years or older;
- MS diagnosis according to McDonald criteria;
- Informed consent to the present study for caregivers:
- 18 years or older;
- in being a person who takes care of a PwMS;
- Informed consent to the present study
Exclusion Criteria:
- not having taken part in one of the following trials evaluated in the present study: A)
Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other
Neurodegenerative Diseases (PIS-A); B) BRAin VEnous DRainage Exploited Against Multiple
Sclerosis (PIS-B).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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MS (Multiple Sclerosis)
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Intervention(s)
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Other: PIS User Testing
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Primary Outcome(s)
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percentage of found and understood-if-found items
[Time Frame: 1 day]
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Secondary Outcome(s)
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understanding of the text expressed by subject
[Time Frame: 1 day]
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Secondary ID(s)
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FISM 2012R2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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