MedTrace Logo

Telemonitoring and Connected Care Applied to Multiple Sclerose

NCT05242731 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2023-10-10

No results posted yet for this study

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 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Isala

    lead OTHER

Principal Investigators

  • Dr E. (Esther) Zeinstra · Isala

  • Prof. S (Silvia) Evers · Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2024-04-29
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05242731 on ClinicalTrials.gov