MS (Multiple Sclerosis)NCT03155334
Understanding Evaluation of Patient Information Sheets by User Testing Method
A study testing PIS User Testing in people with MS (Multiple Sclerosis), run by Fondazione Italiana Sclerosi Multipla at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MS (Multiple Sclerosis)
- What is being tested?
- PIS User Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Jan 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Fondazione Italiana Sclerosi Multipla (FISM)
Genoa, Liguria
Stefano Lionetti, MD
Stefano Lionetti, MD
Romania1 site, 1 recruiting
- Recruiting
Opera Contract Research Organization SRL
Timișoara, Timiș County, 300209
Barattini Dionisio, MD, +393355437574, barattini@operacro.com
About this study
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.
Read the detailed 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.
- Conditions
- MS (Multiple Sclerosis)
- Being tested
- PIS User Testing
- Keywords
- Multiple Sclerosis; Patient Information Sheet; User Testing
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Prevalence of CCSVI in MS | Other | Subjects with prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases - PIS User Testing Receives: Other: PIS User Testing |
| BVD Exploited Against MS | Other | Subjects suffering from Brain venous drainage exploited against Multiple Sclerosis - PIS User Testing Receives: Other: PIS User Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of found and understood-if-found items
percentage
Measured: 1 day
Secondary outcomes (1)
understanding of the text expressed by subject
Visual Analogue Scale (VAS)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start31 Jan 2017
- Primary completion20 Feb 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MS (Multiple Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sclerosi Multipla
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Mario Alberto Battaglia, Prof., Study director, Fondazione Italiana Sclerosi Multipla (FISM), Genova , (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155334
- Sponsor's protocol ID
- FISM 2012R2
- Status last verified
- Jan 2018
- First submitted
- 15 May 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 23583081Knapp 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.
PubMed 19717698Knapp 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.
PubMed 19723335Knapp 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.
PubMed 21777435
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Evaluation of Patient Information Sheets of Two Multiple Sclerosis Studies Through User Testing Method in a Randomized, Open Label, Crossover Design
- ClinicalTrials.gov ID
- NCT03155334
- Acronym / sponsor ID
- FISM 2012R2
- Conditions
- MS (Multiple Sclerosis)
- Keywords
- Multiple Sclerosis; Patient Information Sheet; User Testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Italiana Sclerosi MultiplaUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 20 Feb 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevalence of CCSVI in MS | Other | Other: PIS User TestingSubjects with prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases - PIS User Testing |
| BVD Exploited Against MS | Other | Other: PIS User TestingSubjects suffering from Brain venous drainage exploited against Multiple Sclerosis - PIS User Testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIS User TestingPIS 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. | Other | BVD Exploited Against MS, Prevalence of CCSVI in MS |
Primary outcome
percentage of found and understood-if-found items
Time frame: 1 day
percentage
1 secondary outcome
understanding of the text expressed by subject
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Background: PubMed 23583081Raynor 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.
- Background: PubMed 19717698Knapp 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.
- Background: PubMed 19723335Knapp 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.
- Background: PubMed 21777435Knapp 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.
- Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases (COSMO), ClinicalTrials.gov Identifier: NCT01384825Link provided by the sponsor.
- BRAin VEnous DRainage Exploited Against Multiple Sclerosis (BRAVE-DREAMS), ClinicalTrials.gov Identifier: NCT01371760Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Alberto Battaglia, Prof. study director
Fondazione Italiana Sclerosi Multipla (FISM), Genova , (Italy)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIS User Testing in people with MS (Multiple Sclerosis), run by Fondazione Italiana Sclerosi Multipla at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dionisio Barattini, MD (+393355437574, barattini@operacro.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of found and understood-if-found items (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155334, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.