NCT03155334

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

May 15, 2017

Last Update Submit

January 12, 2018

Conditions

MS (Multiple Sclerosis)

Keywords

Multiple Sclerosis; Patient Information Sheet; User Testing

Outcome Measures

Primary Outcomes (1)

  • percentage of found and understood-if-found items

    percentage

    1 day

Secondary Outcomes (1)

  • understanding of the text expressed by subject

    1 day

Study Arms (2)

Prevalence of CCSVI in MS

OTHER

Subjects with prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases - PIS User Testing

Other: PIS User Testing

BVD Exploited Against MS

OTHER

Subjects suffering from Brain venous drainage exploited against Multiple Sclerosis - PIS User Testing

Other: PIS User Testing

Interventions

PIS User TestingOTHER

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.

BVD Exploited Against MSPrevalence of CCSVI in MS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • for PwMS:
  • years or older;
  • MS diagnosis according to McDonald criteria;
  • Informed consent to the present study for caregivers:
  • years or older;
  • in being a person who takes care of a PwMS;
  • Informed consent to the present study

You may not qualify if:

  • \- 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione Italiana Sclerosi Multipla (FISM)

Genoa, Liguria, Italy

RECRUITING

Opera Contract Research Organization SRL

Timișoara, Timiș County, 300209, Romania

RECRUITING

Related Publications (4)

  • Raynor DK. User testing in developing patient medication information in Europe. Res Social Adm Pharm. 2013 Sep-Oct;9(5):640-5. doi: 10.1016/j.sapharm.2013.02.007. Epub 2013 Apr 10.

    PMID: 23583081BACKGROUND

  • Knapp P, Raynor DK, Silcock J, Parkinson B. Performance-based readability testing of participant materials for a phase I trial: TGN1412. J Med Ethics. 2009 Sep;35(9):573-8. doi: 10.1136/jme.2008.026708.

    PMID: 19717698BACKGROUND

  • Knapp P, Raynor DK, Silcock J, Parkinson B. Performance-based readability testing of participant information for a Phase 3 IVF trial. Trials. 2009 Sep 1;10:79. doi: 10.1186/1745-6215-10-79.

    PMID: 19723335BACKGROUND

  • Knapp P, Raynor DK, Silcock J, Parkinson B. Can user testing of a clinical trial patient information sheet make it fit-for-purpose?--a randomized controlled trial. BMC Med. 2011 Jul 21;9:89. doi: 10.1186/1741-7015-9-89.

    PMID: 21777435BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mario Alberto Battaglia, Prof.

    Fondazione Italiana Sclerosi Multipla (FISM), Genova , (Italy)

    STUDY DIRECTOR

Central Study Contacts

Dionisio Barattini, MD

CONTACT

+393355437574barattini@operacro.ro

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 16, 2017

Study Start

January 31, 2017

Primary Completion

February 20, 2018

Study Completion

December 30, 2018

Last Updated

January 16, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Locations

IT(1)RO(1)