Multiple SclerosisMonSterNCT05242731
Telemonitoring and Connected Care Applied to Multiple Sclerose
A study testing MSmonitor, a self-management/education program with e-health interventions, Video calling program "Better-close" and Researchmanager program in people with Multiple Sclerosis, run by Isala at 4 sites in Netherlands.
Trial summary
The investigators designed a new care concept based on a multi-modal version of the MSmonitor program, the 'MSmonitor-Plus and Video Calling Care' (MPVC). MPVC combines the self-management and education program MSmonitor with video consultations by using specific questionnaires designed for high-frequency/intensive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MSmonitor, a self-management/education program with e-health interventions, Video calling program "Better-close" and Researchmanager program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 4 sitesNetherlands
- Study dates
- 29 Apr 2021to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant is an MS patient who is being treated within the Isala. Is 18 years of age or older Has digital skills
- The caregiver is the caregiver of an MS patient Is older than 18 years
Who cannot join
- The patient does not master the Dutch language. The patient has insufficient computer skills. Disabled adults are excluded from the study.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
University Medical Center Groningen
Groningen, Nederland, 9713AV
University of Maastricht
Maastricht, Nederland, 6200MD
MS4research Institute
Nijmegen, Nederland, 6522KJ
Isala
Zwolle, Nederland, 7943KA
About this study
Official title: MonSter Study, Telemonitoring and Connected Care Applied to Multiple Sclerose
The investigators designed a new care concept based on a multi-modal version of the MSmonitor program, the 'MSmonitor-Plus and Video Calling Care' (MPVC). MPVC combines the self-management and education program MSmonitor with video consultations by using specific questionnaires designed for high-frequency/intensive self-assessments of MS patients.
'The overall objective of this study is to assess the feasibility and (cost)-effectiveness of MPVC compared to Care as Usual (CAU).
Read more
An RCT with two parallel groups will be conducted to compare the MPVC with a CAU in MS patients and their caregivers.
In this study, 208 MS patients will be included with follow-up measurements for two years (at baseline and every three months).
After randomization, 104 patients will be assigned to MPVC and 104 patients to CAU.
The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) process evaluation.
Read the detailed description
Multiple sclerosis (MS) is the most common neurological disorder (1:500-1000) in young adults. It has a profound impact on all aspects of human functioning.
The clinical picture is comprehensive fatigue and often cognitive problems that negatively influenced the quality of life, but also the consultations in the hospital.
MS is not curable. In recent years new treatments have become available. These are more effective (can slow down or even stop MS) but also have more side effects and are more expensive. Careful monitoring based on effectiveness and side effects is therefore important. The result is a high frequency of hospital visits and a great burden on the patient. This great burden is expressed in an increase in the fatigue and cognitive problems that are already present, so the consultation in the hospital provides less information and is less efficient than desired.
Research has also shown, for example, that the complaints that MS patients discuss are mainly from the last 2 weeks. Previous complaints thus remain out of the picture
The aim is to optimize care for MS patients and to improve their quality of life. The costs will also be considered. The telemonitoring will be done by MSmonitor-Plus program with video calling care (MPVC). The MS patients fill in specific questionnaires every 3 months in the MSmonitor Plus. The healthcare professionals (HCP) can view the answers remotely and coordinate the right care. If the telemonitoring shows that the patient is doing well, it can be decided that the patient does not have to come to the hospital for a check-up.
By actively involving MS patients in the MSMonitor-Plus by filling in these questionnaires every 3 months, the HCP get a better picture of the complaints.
All MS patients actively receiving treatment within Isala are eligible for this study. There is randomization in which telemonitoring is compared with standard treatment. One group, the control group (CG) (104) continues care as usual (CAU), the other group, the intervention group (IG) (104) receives MSMonitor Plus and video calling care (MPVC).
During the research, both groups fill in research questionnaires every 3 to 6 months in an electronic case report form (Research Manager). These questionnaires are about general health, MS, health care consumption, autonomy, and quality of life are compared afterward.
A cost-effectiveness analysis will be made of both groups. The study will last a total of 2 years for the participating patients. Previous studies have been done with MSM, but not for a long period.
- Conditions
- Multiple Sclerosis
- Being tested
- MSmonitor, a self-management/education program with e-health interventions, Video calling program "Better-close", Researchmanager program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSmonitor, a self-management/education program with e-health interventionsDevice
A self-management/education program with e-health interventions
Video calling program "Better-close"Device
Video calling program.
Researchmanager programDevice
Case Report Form, Datamanagement program
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Studygroup: Working with MSmonitor and video calling. Complete research questionnaires every 3 months in the Case Report Form, Researchmanager. Receives: Device: MSmonitor, a self-management/education program with e-health interventions; Device: Video calling program "Better-close"; Device: Researchmanager program |
| Controlgroup | Active comparator | Became care as usual (CAU), not working with MSmonitor or video calling. Complete research questionnaires every 3 months in the Case Report Form, researchmanager. Receives: Device: Researchmanager program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is Multiple Sclerose Quality of Life (MSQuol54)
The primary endpoint (MSQoL-54) at which the value of telemonitoring is determined is t=2 years.The 2 composite summary scores are the MSQOL-54 Physical Health Composite Score and the MSQOL-54 Mental Health Composite Score, The highest range is 100, de lowest 0. The lower the outcome (0) the better the quality of life. The higher the outcome (100), the worse the quality of life.
Measured: 2 years
Secondary outcomes (7)
Impact on participation and autonomy (IPA)
An secondary outcome measure is the autonomy of the MS patient.
Measured: 2 years
Work together on health (PIH)
Receiving care that suits the individual
Measured: 2 years
Health questionnaire (Eq5D-5L)
The EQ-5D is a standardized instrument that scores on five health levels (mobility, self-care, daily activities, pain/discomfort, and anxiety/depression). From this, a weighted health index can be derived for an individual or population.
Measured: 2 years
MS Self-Efficacy Scale (MSSES)
Confidence in being able to undertake daily activities and have control over activities related to MS.
Measured: 2 years
Medical Consumption Questionnaire (iMCQ)
The iMCQ is a non-disease-specific questionnaire that aims to estimate the direct costs of medical care.
Measured: 2 years
Productivity Costs Questionnaire (iPCQ)
The iPCQ aims to measure and subsequently value the indirect costs outside of healthcare: productivity costs
Measured: 2 years
Patient satisfaction questionnaire (PTO)
Patient satisfaction questionnaire about care provided
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start29 Apr 2021
- Primary completion29 Apr 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, randomized control, non inferiority trial
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlies Hoving, Isala
- Investigators
- Dr E. (Esther) Zeinstra, Study director, IsalaProf. S (Silvia) Evers, Study director, Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242731
- Sponsor's protocol ID
- MonSter75251
- Acronym
- MonSter
- Status last verified
- Oct 2023
- First submitted
- 23 Jan 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoving M, Jongen PJ, Evers SMAA, Edens MA, Zeinstra EMPE. MSmonitor-plus program and video calling care (MPVC) for multidisciplinary care and self-management in multiple sclerosis: study protocol of a single-center randomized, parallel-group, open label, non-inferiority trial. BMC Neurol. 2022 Nov 12;22(1):423. doi: 10.1186/s12883-022-02948-z.
PubMed 36371162
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MonSter Study, Telemonitoring and Connected Care Applied to Multiple Sclerose
- ClinicalTrials.gov ID
- NCT05242731
- Acronym / sponsor ID
- MonSter / MonSter75251
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 29 Apr 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Feb 2022 (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 investigators designed a new care concept based on a multi-modal version of the MSmonitor program, the 'MSmonitor-Plus and Video Calling Care' (MPVC). MPVC combines the self-management and education program MSmonitor with video consultations by using specific questionnaires designed for high-frequency/intensive self-assessments of MS patients.
'The overall objective of this study is to assess the feasibility and (cost)-effectiveness of MPVC compared to Care as Usual (CAU).
An RCT with two parallel groups will be conducted to compare the MPVC with a CAU in MS patients and their caregivers.
In this study, 208 MS patients will be included with follow-up measurements for two years (at baseline and every three months).
After randomization, 104 patients will be assigned to MPVC and 104 patients to CAU.
The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) process evaluation.
Detailed description
Multiple sclerosis (MS) is the most common neurological disorder (1:500-1000) in young adults. It has a profound impact on all aspects of human functioning.
The clinical picture is comprehensive fatigue and often cognitive problems that negatively influenced the quality of life, but also the consultations in the hospital.
MS is not curable. In recent years new treatments have become available. These are more effective (can slow down or even stop MS) but also have more side effects and are more expensive. Careful monitoring based on effectiveness and side effects is therefore important. The result is a high frequency of hospital visits and a great burden on the patient. This great burden is expressed in an increase in the fatigue and cognitive problems that are already present, so the consultation in the hospital provides less information and is less efficient than desired.
Research has also shown, for example, that the complaints that MS patients discuss are mainly from the last 2 weeks. Previous complaints thus remain out of the picture
The aim is to optimize care for MS patients and to improve their quality of life. The costs will also be considered. The telemonitoring will be done by MSmonitor-Plus program with video calling care (MPVC). The MS patients fill in specific questionnaires every 3 months in the MSmonitor Plus. The healthcare professionals (HCP) can view the answers remotely and coordinate the right care. If the telemonitoring shows that the patient is doing well, it can be decided that the patient does not have to come to the hospital for a check-up.
By actively involving MS patients in the MSMonitor-Plus by filling in these questionnaires every 3 months, the HCP get a better picture of the complaints.
All MS patients actively receiving treatment within Isala are eligible for this study. There is randomization in which telemonitoring is compared with standard treatment. One group, the control group (CG) (104) continues care as usual (CAU), the other group, the intervention group (IG) (104) receives MSMonitor Plus and video calling care (MPVC).
During the research, both groups fill in research questionnaires every 3 to 6 months in an electronic case report form (Research Manager). These questionnaires are about general health, MS, health care consumption, autonomy, and quality of life are compared afterward.
A cost-effectiveness analysis will be made of both groups. The study will last a total of 2 years for the participating patients. Previous studies have been done with MSM, but not for a long period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, randomized control, non inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Device: MSmonitor, a self-management/education program with e-health interventions, Device: Video calling program "Better-close", Device: Researchmanager programStudygroup: Working with MSmonitor and video calling. Complete research questionnaires every 3 months in the Case Report Form, Researchmanager. |
| Controlgroup | Active comparator | Device: Researchmanager programBecame care as usual (CAU), not working with MSmonitor or video calling. Complete research questionnaires every 3 months in the Case Report Form, researchmanager. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The participant is an MS patient who is being treated within the Isala. Is 18 years of age or older Has digital skills
- The caregiver is the caregiver of an MS patient Is older than 18 years
Key exclusion criteria (1 listed)
- The patient does not master the Dutch language. The patient has insufficient computer skills. Disabled adults are excluded from the study.
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 |
|---|---|---|
| MSmonitor, a self-management/education program with e-health interventionsA self-management/education program with e-health interventions | Device | Study group |
| Video calling program "Better-close"Video calling program. | Device | Study group |
| Researchmanager programCase Report Form, Datamanagement program | Device | Controlgroup, Study group |
Primary outcome
The primary endpoint is Multiple Sclerose Quality of Life (MSQuol54)
Time frame: 2 years
The primary endpoint (MSQoL-54) at which the value of telemonitoring is determined is t=2 years.The 2 composite summary scores are the MSQOL-54 Physical Health Composite Score and the MSQOL-54 Mental Health Composite Score, The highest range is 100, de lowest 0. The lower the outcome (0) the better the quality of life. The higher the outcome (100), the worse the quality of life.
7 secondary outcomes
Impact on participation and autonomy (IPA)
Time frame: 2 years
Work together on health (PIH)
Time frame: 2 years
Health questionnaire (Eq5D-5L)
Time frame: 2 years
MS Self-Efficacy Scale (MSSES)
Time frame: 2 years
Medical Consumption Questionnaire (iMCQ)
Time frame: 2 years
Productivity Costs Questionnaire (iPCQ)
Time frame: 2 years
Patient satisfaction questionnaire (PTO)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 36371162Hoving M, Jongen PJ, Evers SMAA, Edens MA, Zeinstra EMPE. MSmonitor-plus program and video calling care (MPVC) for multidisciplinary care and self-management in multiple sclerosis: study protocol of a single-center randomized, parallel-group, open label, non-inferiority trial. BMC Neurol. 2022 Nov 12;22(1):423. doi: 10.1186/s12883-022-02948-z.
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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.
Dr E. (Esther) Zeinstra study director
Isala
Prof. S (Silvia) Evers study director
Maastricht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSmonitor, a self-management/education program with e-health interventions, Video calling program "Better-close" and Researchmanager program in people with Multiple Sclerosis, run by Isala at 4 sites 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 2 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
The primary endpoint is Multiple Sclerose Quality of Life (MSQuol54) (time frame: 2 years). 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 NCT05242731, which also lists 1 linked publication.
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 10 Oct 2023.