Multiple SclerosisUMIMSNCT03872583
Understanding Magnetic Resonance Imaging in Multiple Sclerosis
A study testing Understanding MRI in MS (website) in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Magnetic resonance imaging (MRI) results play a major role in the lives of people with multiple sclerosis (pwMS). Even though MRI is used for diagnosis, prognosis and therapy control, pwMS' knowledge concerning this complex matter is scarce. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome
- What is being tested?
- Understanding MRI in MS (website)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2019to 1 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years 65 years
- MRI within 6 weeks to 6 months
- internet access AND
- diagnosis of relapsing-remitting MS (RRMS) according to the McDonald criteria (Thompson et al., 2018), <10 years disease duration + active disease course (i.e. therapy change or new T2 lesion within the previous year) OR
- clinically isolated syndrome (CIS) (with at least one MS-typical T2 lesion)
Who cannot join
- diagnosis of secondary-progressive MS
- diagnosis of primary-progressive MS
- diagnosis or suspected central nervous system disease other than MS
- severe cognitive deficit
- major psychiatric illness
- patients who are related to medical personnel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Magnetic Resonance Imaging in Multiple Sclerosis - a Randomized, Controlled, Double Blind Trial
Magnetic resonance imaging (MRI) results play a major role in the lives of people with multiple sclerosis (pwMS). Even though MRI is used for diagnosis, prognosis and therapy control, pwMS' knowledge concerning this complex matter is scarce. Without adequate disease-specific knowledge, pwMS cannot truly make an informed choice when considering their MRI results (e.g. necessity of future MRI scans or therapy change).
The investigators have developed an innovative, evidence-based and interactive online education tool called "Understanding MRI in MS", which incorporates all relevant information about MRI in MS and its implications in disease management.
In this randomized, controlled and double-blind trial the tool's effect on MRI-specific knowledge, self-perceived competence and involvement in medical decision, that are based on MRI results will be assessed.
Read the detailed description
For the randomized controlled trial (RCT), n=120 consecutive patients of 4 centers, for whom a brain (or brain and spine) MRI scan is planned within the next 6 months, will be invited to participate in the trial. Eligible patients will be asked to participate, and, if willing, will receive information about the study by the recruiting physician and written consent will be obtained. Participants will then answer a baseline questionnaire including demographic data, numeracy, attitude and emotions towards MRI (MRI-emotions and attitude questionnaire, MRI-EMA, newly developed) and MRI-specific knowledge (MRI-risk knowledge questionnaire 2.0, MRI-RIKNO 2.0, newly developed).
Patients will then be randomized into two groups: The intervention group of n=60 participants gets access to the web-based educational tool, the control group of n=60 to a sham intervention with standard information on MRI.
Participants will be asked to provide an e-mail address via which the login for the educational tool will be delivered. After two weeks participants will be asked to fill out the following tools:
Primary endpoint
- MRI-risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0) (newly developed)
- MRI-emotions and attitude questionnaire (MRI-EMA) (newly developed)
- Threat by MS
- Autonomy preferences (Control Preference Scale)
- Subjective knowledge (VAS scale) (22)
Within the course of 2 weeks to 6 months the scheduled MRI will take place, followed by a patient-physician encounter, in which the MRI results are discussed. Directly after this encounter patients and physicians will be asked to answer MAPPIN'SDM questionnaires to assess perceived shared decision making behaviour and realization of autonomy preferences (Control reference scale). All patients will also be asked questions concerning any decisions taken based on the MRI, either a start/change of treatment or agreement on a new MRI in a defined time-frame. N=5 patients of each arm in the study center in Hamburg will be randomly selected and the communication of results during this consultation will be audiotaped and evaluated using the MAPPIN'SDM observer rating approach.
In a telephone follow-up after 6 months, implementation of the decisions will be checked.
- Being tested
- Understanding MRI in MS (website), Control website
- Keywords
- Patient education, Disease-specific knowledge, Shared decision making
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Understanding MRI in MS (website)Other
Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis.
Control websiteOther
Access to a specifically designed control website containing information on MRI in MS freely available on the websites of major European MS self-help organizations.
| Study group | Role | What they receive |
|---|---|---|
| Understanding MRI in MS (website) | Experimental | Participants will receive access to a newly developed, innovative, interactive and evidence-based education tool about magnetic resonance imaging in multiple sclerosis. Receives: Other: Understanding MRI in MS (website) |
| Control website | Active comparator | Participants will receive access to a specifically designed control website containing the information about magnetic resonance imaging in multiple sclerosis, that is freely available on the websites of major European multiple sclerosis self help organization (Australia, Belgium, Canada, France, Germany, Great Britain, Netherland, USA). Receives: Other: Control website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0)
15-item magnetic resonance imaging-specific knowledge questionnaire (min. points 0, maximum points 22; higher values indicate greater knowledge)
Measured: 2 weeks
Secondary outcomes (5)
Emotions and attitude towards magnetic resonance imaging (MRI-EMA)
Validated 10-item questionnaire on emotions and attitude towards magnetic resonance imaging, sub-scales (min. value: 1, max. value: 4; higher values indicate greater expression of the feature): 1) Fear of MRI scan, 2) Fear of MRI results, 3) Feeling of control, 4) Feeling of competence
Measured: Baseline, 2 weeks
Control preference scale (CPS)
Scale to assess autonomy preferences during medical decisions (5 categories between complete autonomy and paternalistic decision making as the extremes)
Measured: Baseline, 2 weeks, after patient-physician encounter (i.e. 4 weeks to 6 months after baseline)
Threat by MS
Visual analogue scale to assess anxiety associated with disease progression (min. 0, max. 100; higher values indicate higher subjective threat)
Measured: baseline, 2 weeks
Hospital Anxiety and Depression Scale (HADS)
Questionnaire to assess anxiety and depression (min. 0, max. 42 points (21 points for each subscale, subscales are added); higher values indicate more severe depression/anxiety)
Measured: Baseline, 2 weeks
Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)
Tool to assess the amount of shared decision making during a patient-physician encounter (min. value 0, max. value 45; higher values indicated higher level of shared decision making)
Measured: after patient-physician-encounter (i.e. 4 weeks to 6 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start15 Mar 2019
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, double-blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Christoph Heesen, Prof., Principal investigator, University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872583
- Sponsor's protocol ID
- PV5722
- Acronym
- UMIMS
- Status last verified
- Dec 2023
- First submitted
- 25 Jan 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brand J, Kopke S, Kasper J, Rahn A, Backhus I, Poettgen J, Stellmann JP, Siemonsen S, Heesen C. Magnetic resonance imaging in multiple sclerosis--patients' experiences, information interests and responses to an education programme. PLoS One. 2014 Nov 21;9(11):e113252. doi: 10.1371/journal.pone.0113252. eCollection 2014.
PubMed 25415501Gaissmaier W, Giese H, Galesic M, Garcia-Retamero R, Kasper J, Kleiter I, Meuth SG, Kopke S, Heesen C. Numeracy of multiple sclerosis patients: A comparison of patients from the PERCEPT study to a German probabilistic sample. Patient Educ Couns. 2018 Jan;101(1):74-78. doi: 10.1016/j.pec.2017.07.018. Epub 2017 Jul 17.
PubMed 28764895Heesen C, Kasper J, Fischer K, Kopke S, Rahn A, Backhus I, Poettgen J, Vahter L, Drulovic J, Van Nunen A, Beckmann Y, Liethmann K, Giordano A, Fulcher G, Solari A; AutoMS-group. Risk Knowledge in Relapsing Multiple Sclerosis (RIKNO 1.0)--Development of an Outcome Instrument for Educational Interventions. PLoS One. 2015 Oct 2;10(10):e0138364. doi: 10.1371/journal.pone.0138364. eCollection 2015.
PubMed 26430887Heesen C, Kasper J, Kopke S, Richter T, Segal J, Muhlhauser I. Informed shared decision making in multiple sclerosis--inevitable or impossible? J Neurol Sci. 2007 Aug 15;259(1-2):109-17. doi: 10.1016/j.jns.2006.05.074. Epub 2007 Apr 2.
PubMed 17400253Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488Boeije HR, Janssens AC. 'It might happen or it might not': how patients with multiple sclerosis explain their perception of prognostic risk. Soc Sci Med. 2004 Aug;59(4):861-8. doi: 10.1016/j.socscimed.2003.11.040.
PubMed 15177841Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
PubMed 9505581Riechel C, Alegiani AC, Kopke S, Kasper J, Rosenkranz M, Thomalla G, Heesen C. Subjective and objective knowledge and decisional role preferences in cerebrovascular patients compared to controls. Patient Prefer Adherence. 2016 Aug 2;10:1453-60. doi: 10.2147/PPA.S98342. eCollection 2016.
PubMed 27536077Kasper J, Hoffmann F, Heesen C, Kopke S, Geiger F. MAPPIN'SDM--the multifocal approach to sharing in shared decision making. PLoS One. 2012;7(4):e34849. doi: 10.1371/journal.pone.0034849. Epub 2012 Apr 13.
PubMed 22514677Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Schiffmann I, Freund M, Vettorazzi E, Stellmann JP, Heyer-Borchelt S, D'Hooghe M, Haussler V, Rahn AC, Heesen C. Assessing the effect of an evidence-based patient online educational tool for people with multiple sclerosis called UMIMS-understanding magnetic resonance imaging in multiple sclerosis: study protocol for a double-blind, randomized controlled trial. Trials. 2020 Dec 9;21(1):1008. doi: 10.1186/s13063-020-04855-5.
PubMed 33298133
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Magnetic Resonance Imaging in Multiple Sclerosis - a Randomized, Controlled, Double Blind Trial
- ClinicalTrials.gov ID
- NCT03872583
- Acronym / sponsor ID
- UMIMS / PV5722
- Keywords
- Patient education, Disease-specific knowledge, Shared decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 Mar 2019 (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.
Magnetic resonance imaging (MRI) results play a major role in the lives of people with multiple sclerosis (pwMS). Even though MRI is used for diagnosis, prognosis and therapy control, pwMS' knowledge concerning this complex matter is scarce. Without adequate disease-specific knowledge, pwMS cannot truly make an informed choice when considering their MRI results (e.g. necessity of future MRI scans or therapy change).
The investigators have developed an innovative, evidence-based and interactive online education tool called "Understanding MRI in MS", which incorporates all relevant information about MRI in MS and its implications in disease management.
In this randomized, controlled and double-blind trial the tool's effect on MRI-specific knowledge, self-perceived competence and involvement in medical decision, that are based on MRI results will be assessed.
Detailed description
For the randomized controlled trial (RCT), n=120 consecutive patients of 4 centers, for whom a brain (or brain and spine) MRI scan is planned within the next 6 months, will be invited to participate in the trial. Eligible patients will be asked to participate, and, if willing, will receive information about the study by the recruiting physician and written consent will be obtained. Participants will then answer a baseline questionnaire including demographic data, numeracy, attitude and emotions towards MRI (MRI-emotions and attitude questionnaire, MRI-EMA, newly developed) and MRI-specific knowledge (MRI-risk knowledge questionnaire 2.0, MRI-RIKNO 2.0, newly developed).
Patients will then be randomized into two groups: The intervention group of n=60 participants gets access to the web-based educational tool, the control group of n=60 to a sham intervention with standard information on MRI.
Participants will be asked to provide an e-mail address via which the login for the educational tool will be delivered. After two weeks participants will be asked to fill out the following tools:
Primary endpoint
- MRI-risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0) (newly developed)
- MRI-emotions and attitude questionnaire (MRI-EMA) (newly developed)
- Threat by MS
- Autonomy preferences (Control Preference Scale)
- Subjective knowledge (VAS scale) (22)
Within the course of 2 weeks to 6 months the scheduled MRI will take place, followed by a patient-physician encounter, in which the MRI results are discussed. Directly after this encounter patients and physicians will be asked to answer MAPPIN'SDM questionnaires to assess perceived shared decision making behaviour and realization of autonomy preferences (Control reference scale). All patients will also be asked questions concerning any decisions taken based on the MRI, either a start/change of treatment or agreement on a new MRI in a defined time-frame. N=5 patients of each arm in the study center in Hamburg will be randomly selected and the communication of results during this consultation will be audiotaped and evaluated using the MAPPIN'SDM observer rating approach.
In a telephone follow-up after 6 months, implementation of the decisions will be checked.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blind trial
| Arm | Type | Receives |
|---|---|---|
| Understanding MRI in MS (website) | Experimental | Other: Understanding MRI in MS (website)Participants will receive access to a newly developed, innovative, interactive and evidence-based education tool about magnetic resonance imaging in multiple sclerosis. |
| Control website | Active comparator | Other: Control websiteParticipants will receive access to a specifically designed control website containing the information about magnetic resonance imaging in multiple sclerosis, that is freely available on the websites of major European multiple sclerosis self help organization (Australia, Belgium, Canada, France, Germany, Great Britain, Netherland, USA). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years 65 years
- MRI within 6 weeks to 6 months
- internet access AND
- diagnosis of relapsing-remitting MS (RRMS) according to the McDonald criteria (Thompson et al., 2018), <10 years disease duration + active disease course (i.e. therapy change or new T2 lesion within the previous year) OR
- clinically isolated syndrome (CIS) (with at least one MS-typical T2 lesion)
Key exclusion criteria (6 listed)
- diagnosis of secondary-progressive MS
- diagnosis of primary-progressive MS
- diagnosis or suspected central nervous system disease other than MS
- severe cognitive deficit
- major psychiatric illness
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 |
|---|---|---|
| Understanding MRI in MS (website)Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis. | Other | Understanding MRI in MS (website) |
| Control websiteAccess to a specifically designed control website containing information on MRI in MS freely available on the websites of major European MS self-help organizations. | Other | Control website |
Primary outcome
Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0)
Time frame: 2 weeks
15-item magnetic resonance imaging-specific knowledge questionnaire (min. points 0, maximum points 22; higher values indicate greater knowledge)
5 secondary outcomes
Emotions and attitude towards magnetic resonance imaging (MRI-EMA)
Time frame: Baseline, 2 weeks
Control preference scale (CPS)
Time frame: Baseline, 2 weeks, after patient-physician encounter (i.e. 4 weeks to 6 months after baseline)
Threat by MS
Time frame: baseline, 2 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 2 weeks
Multifocal Approach to Sharing in Shared Decision Making (MAPPIN'SDM)
Time frame: after patient-physician-encounter (i.e. 4 weeks to 6 months after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 25415501Brand J, Kopke S, Kasper J, Rahn A, Backhus I, Poettgen J, Stellmann JP, Siemonsen S, Heesen C. Magnetic resonance imaging in multiple sclerosis--patients' experiences, information interests and responses to an education programme. PLoS One. 2014 Nov 21;9(11):e113252. doi: 10.1371/journal.pone.0113252. eCollection 2014.
- Background: PubMed 28764895Gaissmaier W, Giese H, Galesic M, Garcia-Retamero R, Kasper J, Kleiter I, Meuth SG, Kopke S, Heesen C. Numeracy of multiple sclerosis patients: A comparison of patients from the PERCEPT study to a German probabilistic sample. Patient Educ Couns. 2018 Jan;101(1):74-78. doi: 10.1016/j.pec.2017.07.018. Epub 2017 Jul 17.
- Background: PubMed 26430887Heesen C, Kasper J, Fischer K, Kopke S, Rahn A, Backhus I, Poettgen J, Vahter L, Drulovic J, Van Nunen A, Beckmann Y, Liethmann K, Giordano A, Fulcher G, Solari A; AutoMS-group. Risk Knowledge in Relapsing Multiple Sclerosis (RIKNO 1.0)--Development of an Outcome Instrument for Educational Interventions. PLoS One. 2015 Oct 2;10(10):e0138364. doi: 10.1371/journal.pone.0138364. eCollection 2015.
- Background: PubMed 17400253Heesen C, Kasper J, Kopke S, Richter T, Segal J, Muhlhauser I. Informed shared decision making in multiple sclerosis--inevitable or impossible? J Neurol Sci. 2007 Aug 15;259(1-2):109-17. doi: 10.1016/j.jns.2006.05.074. Epub 2007 Apr 2.
- Background: PubMed 18824488Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
- Background: PubMed 15177841Boeije HR, Janssens AC. 'It might happen or it might not': how patients with multiple sclerosis explain their perception of prognostic risk. Soc Sci Med. 2004 Aug;59(4):861-8. doi: 10.1016/j.socscimed.2003.11.040.
- Background: PubMed 9505581Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
- Background: PubMed 27536077Riechel C, Alegiani AC, Kopke S, Kasper J, Rosenkranz M, Thomalla G, Heesen C. Subjective and objective knowledge and decisional role preferences in cerebrovascular patients compared to controls. Patient Prefer Adherence. 2016 Aug 2;10:1453-60. doi: 10.2147/PPA.S98342. eCollection 2016.
- Background: PubMed 22514677Kasper J, Hoffmann F, Heesen C, Kopke S, Geiger F. MAPPIN'SDM--the multifocal approach to sharing in shared decision making. PLoS One. 2012;7(4):e34849. doi: 10.1371/journal.pone.0034849. Epub 2012 Apr 13.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Derived from this study: PubMed 33298133Schiffmann I, Freund M, Vettorazzi E, Stellmann JP, Heyer-Borchelt S, D'Hooghe M, Haussler V, Rahn AC, Heesen C. Assessing the effect of an evidence-based patient online educational tool for people with multiple sclerosis called UMIMS-understanding magnetic resonance imaging in multiple sclerosis: study protocol for a double-blind, randomized controlled trial. Trials. 2020 Dec 9;21(1):1008. doi: 10.1186/s13063-020-04855-5.
- Individual participant dataSharing planned: Undecided
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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.
Christoph Heesen, Prof. principal investigator
University Medical Center Hamburg-Eppendorf; Institute for Neuroimmunology and Multiple Sclerosis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Understanding MRI in MS (website) in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic resonance imaging risk knowledge questionnaire 2.0 (MRI-RIKNO 2.0) (time frame: 2 weeks). 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 NCT03872583, which also lists 11 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 3 Jan 2024.