MonSter Study, Telemonitoring and Connected Care Applied to Multiple Sclerose

Status unknownNot a drug-phase studyMS (type not specified)NCT05242731

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • MSmonitor, a self-management/education program with e-health interventions
  • Video calling program "Better-close"
  • Researchmanager program

What it measured

Main measures

  • The primary endpoint is Multiple Sclerose Quality of Life (MSQuol54)

    2 years

    Quality of life (reported by participants)

Other measures (7)

  • Impact on participation and autonomy (IPA)

    2 years

  • Work together on health (PIH)

    2 years

  • Health questionnaire (Eq5D-5L)

    2 years

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • MS Self-Efficacy Scale (MSSES)

    2 years

  • Medical Consumption Questionnaire (iMCQ)

    2 years

  • Productivity Costs Questionnaire (iPCQ)

    2 years

  • Patient satisfaction questionnaire (PTO)

    2 years

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Apr 2021

    2. Main results due

      Apr 2024

    3. Finished

      Dec 2025

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