Multiple SclerosisMSSMNCT06125301
Multiple Sclerosis Self Monitoring Study
A study testing MS Sherpa in people with Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
This study is a multicenter, prospective, randomized controlled trial (RCT) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MS Sherpa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Aug 2022to 15 Aug 2024
- 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
- Signed informed consent form.
- Able to comply with the study protocol, as judged by the investigator.
- A minimum age of 18 years.
- Have a definite diagnosis of RRMS according to the revised McDonald 2017 criteria.
- Have a length of disease duration of ≥12 months, from date of MS diagnosis.
- Have clinical disease activity (one or more reported relapses) and/or radiological disease activity (new/enlarged T2 lesions or T1 contrast-enhancing lesions) within the past 12 months.
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- Willing and able to install and use MS sherpa® on own smartphone with Android (version 4.4 or higher) or iOS (version 9 or higher) operating system.
- Willing to stay for treatment with the same hospital during the year of study.
- Willing to follow the rules of conduct as described in Appendix A during the year of study.
Who cannot join
- EDSS of > 6.5 at baseline screening.
- Presence of a cognitive, visual or upper extremity deficit that disables the use or measurements of MS sherpa® on the smartphone, as judged by the investigator.
- Concomitant use of health monitoring apps or devices for MS during the study.
- Concomitant participation in another intervention trial in MS.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, locatie VUmc
Amsterdam
Pam Molenaar, MD, +31625716307, p.c.g.molenaar@amsterdamumc.nl
About this study
Official title: The Multiple Sclerosis Self Monitoring Study: An Intervention Study on the Effect of Digital Self-monitoring-based Management of Relapsing and Remitting Multiple Sclerosis on Self-efficacy, Clinical Outcomes and Cost-effectiveness
This study is a multicenter, prospective, randomized controlled trial (RCT) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). RRMS patients will be recruited and screened for study eligibility at four Dutch MS centers. Following inclusion, participants will be randomly allocated to the intervention group (use of MS sherpa® in addition to standard care) or control group (standard care only). The duration of follow-up is 12 months with study visits at baseline and 12 months, and additional study assessments coupled with every clinical visit as part of standard care during the follow-up period.
- Conditions
- Multiple Sclerosis
- Being tested
- MS Sherpa
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS SherpaDevice
MS sherpa® is a medical device, intended to support monitoring of persons with MS in order to give patients and their professional healthcare team(s) insight into the presence and progress of symptoms related to MS. MS sherpa® is a system consisting of a smartphone app for data collection and data presentation, a cloud service for data storage, analysis algorithms, and a clinician or research dashboard for user management and data visualization. The device measures the course of symptoms related to MS with respect to walking speed (average walking speed derived from the distance walked during a 2-minute walk), cognitive processing speed, number of correct answers on a smartphone variant of the symbol digit modalities test (SDMT) and patient reported outcomes, through predefined questionnaires regarding fatigue, amongst others. MS sherpa® measures changes in these parameters over time and shows these on an insights screen in the app and on the clinician dashboard.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Care as usual + weekly self-monitoring during one year follow-up and discussing app results with caregivers. Receives: Device: MS Sherpa |
| Control group | No intervention | Care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Multiple Sclerosis Self-Efficacy Control scale (MSSE-C)
the MS Self-Efficacy scale is an 18-item scale assessing self-rated certainty regarding specific behaviours related to functional independence and psychological management of MS. Items are rated on a scale from 10 (very uncertain) to 100 (very certain). The MSSE consist of two subscales by summing the respective items: SE Function, and SE Control.
Measured: One year
Secondary outcomes (2)
Decision making process - caregiver
Provider Decision Process Assessment Instrument (PDPAI) for neurologists, adapted with an additional five questions about the use of MS sherpa® in the decision-making process.
Measured: One year
Decision making process - patient
Decisional Conflict Scale (DCS) for persons with MS, adapted with an additional five questions about the use of MS sherpa® in the decision-making process.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start15 Aug 2022
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joep Killestein, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125301
- Sponsor's protocol ID
- NL75687.029.20
- Acronym
- MSSM
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multiple Sclerosis Self Monitoring Study: An Intervention Study on the Effect of Digital Self-monitoring-based Management of Relapsing and Remitting Multiple Sclerosis on Self-efficacy, Clinical Outcomes and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT06125301
- Acronym / sponsor ID
- MSSM / NL75687.029.20
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 9 Nov 2023 (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.
This study is a multicenter, prospective, randomized controlled trial (RCT) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). RRMS patients will be recruited and screened for study eligibility at four Dutch MS centers. Following inclusion, participants will be randomly allocated to the intervention group (use of MS sherpa® in addition to standard care) or control group (standard care only). The duration of follow-up is 12 months with study visits at baseline and 12 months, and additional study assessments coupled with every clinical visit as part of standard care during the follow-up period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: MS SherpaCare as usual + weekly self-monitoring during one year follow-up and discussing app results with caregivers. |
| Control group | No intervention | –Care as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent form.
- Able to comply with the study protocol, as judged by the investigator.
- A minimum age of 18 years.
- Have a definite diagnosis of RRMS according to the revised McDonald 2017 criteria.
- Have a length of disease duration of ≥12 months, from date of MS diagnosis.
Key exclusion criteria (4 listed)
- EDSS of > 6.5 at baseline screening.
- Presence of a cognitive, visual or upper extremity deficit that disables the use or measurements of MS sherpa® on the smartphone, as judged by the investigator.
- Concomitant use of health monitoring apps or devices for MS during the study.
- Concomitant participation in another intervention trial in MS.
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 |
|---|---|---|
| MS SherpaMS sherpa® is a medical device, intended to support monitoring of persons with MS in order to give patients and their professional healthcare team(s) insight into the presence and progress of symptoms related to MS. MS sherpa® is a system consisting of a smartphone app for data collection and data presentation, a cloud service for data storage, analysis algorithms, and a clinician or research dashboard for user management and data visualization. The device measures the course of symptoms related to MS with respect to walking speed (average walking speed derived from the distance walked during a 2-minute walk), cognitive processing speed, number of correct answers on a smartphone variant of the symbol digit modalities test (SDMT) and patient reported outcomes, through predefined questionnaires regarding fatigue, amongst others. MS sherpa® measures changes in these parameters over time and shows these on an insights screen in the app and on the clinician dashboard. | Device | Intervention group |
Primary outcome
the Multiple Sclerosis Self-Efficacy Control scale (MSSE-C)
Time frame: One year
the MS Self-Efficacy scale is an 18-item scale assessing self-rated certainty regarding specific behaviours related to functional independence and psychological management of MS. Items are rated on a scale from 10 (very uncertain) to 100 (very certain). The MSSE consist of two subscales by summing the respective items: SE Function, and SE Control.
2 secondary outcomes
Decision making process - caregiver
Time frame: One year
Decision making process - patient
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS Sherpa in people with Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 9 inclusion and 4 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 9 Nov 2023. 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Multiple Sclerosis Self-Efficacy Control scale (MSSE-C) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2023.