Telemonitoring and Connected Care Applied to Multiple Sclerose

Study Overview
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Brief Summary
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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
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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.

Official Title
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MonSter Study, Telemonitoring and Connected Care Applied to Multiple Sclerose

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: MSmonitor, a self-management/education program with e-health interventions
* Device: Video calling program Better-close
* Device: Researchmanager program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: The patient does not master the Dutch language. The patient has insufficient computer skills. Disabled adults are excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center, randomized control, non inferiority trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>Studygroup: Working with MSmonitor and video calling. Complete research questionnaires every 3 months in the Case Report Form, Researchmanager. | Device: MSmonitor, a self-management/education program with e-health interventions<br>* A self-management/education program with e-health interventions<br>Device: Video calling program Better-close<br>* Video calling program.<br>Device: Researchmanager program<br>* Case Report Form, Datamanagement program<br>|
| Active Comparator: Controlgroup<br>Became care as usual (CAU), not working with MSmonitor or video calling. Complete research questionnaires every 3 months in the Case Report Form, researchmanager. | Device: Researchmanager program<br>* Case Report Form, Datamanagement program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on participation and autonomy (IPA) | An secondary outcome measure is the autonomy of the MS patient. | 2 years | 
| Work together on health (PIH) | Receiving care that suits the individual | 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. | 2 years | 
| MS Self-Efficacy Scale (MSSES) | Confidence in being able to undertake daily activities and have control over activities related to MS. | 2 years | 
| Medical Consumption Questionnaire (iMCQ) | The iMCQ is a non-disease-specific questionnaire that aims to estimate the direct costs of medical care. | 2 years | 
| Productivity Costs Questionnaire (iPCQ) | The iPCQ aims to measure and subsequently value the indirect costs outside of healthcare: productivity costs | 2 years | 
| Patient satisfaction questionnaire (PTO) | Patient satisfaction questionnaire about care provided | 2 years |