Telemonitoring and Connected Care Applied to Multiple Sclerose (MonSter)

October 6, 2023 updated by: Marlies Hoving, Isala

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).

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Nederland
      • Groningen, Nederland, Netherlands, 9713AV
        • University Medical Center Groningen
      • Maastricht, Nederland, Netherlands, 6200MD
        • University of Maastricht
      • Nijmegen, Nederland, Netherlands, 6522KJ
        • MS4research Institute
      • Zwolle, Nederland, Netherlands, 7943KA
        • Isala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group
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
A self-management/education program with e-health interventions
Device: Video calling program "Better-close"
Video calling program.
Device: Researchmanager program
Case Report Form, Datamanagement program
Active Comparator: Controlgroup
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
Case Report Form, Datamanagement program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on participation and autonomy (IPA)
Time Frame: 2 years
An secondary outcome measure is the autonomy of the MS patient.
2 years
Work together on health (PIH)
Time Frame: 2 years
Receiving care that suits the individual
2 years
Health questionnaire (Eq5D-5L)
Time Frame: 2 years
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)
Time Frame: 2 years
Confidence in being able to undertake daily activities and have control over activities related to MS.
2 years
Medical Consumption Questionnaire (iMCQ)
Time Frame: 2 years
The iMCQ is a non-disease-specific questionnaire that aims to estimate the direct costs of medical care.
2 years
Productivity Costs Questionnaire (iPCQ)
Time Frame: 2 years
The iPCQ aims to measure and subsequently value the indirect costs outside of healthcare: productivity costs
2 years
Patient satisfaction questionnaire (PTO)
Time Frame: 2 years
Patient satisfaction questionnaire about care provided
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Investigators

  • Study Director: Dr E. (Esther) Zeinstra, Isala
  • Study Director: Prof. S (Silvia) Evers, Maastricht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Estimated)

April 29, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MonSter75251

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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