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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Remote MS Care in Antwerp

Study Purpose

Current clinical follow-up of multiple sclerosis (MS) patients suffers from some challenges, as many patients indicate they want to take up a more active role in the decision-making process. However, more than half of MS patients do not consider themselves well informed about their disease. Communication between patients and healthcare professionals (HCPs) has also been reported to be suboptimal, with incorrect alignment between patients and HCPs as a result and relapses going undetected. Digital telemonitoring tools could play a role in educating MS patients, allowing them to take up a more active role in the clinical decision-making process. Additionally, remote monitoring could lead to a better alignment between patient and HCPs and could ultimately even lead to a more efficient clinical workflow. In this study, the investigators will investigate an existing digital telemonitoring solution called icompanion, developed by Icometrix. icompanion is a class 1 medical device in US (Food and Drug Administration

  • - FDA) and Europe (Medical Device Directive - MDD).
Using the icompanion MS app and website, patients can keep a diary, log symptoms, and perform tests for body function, cognitive function and fatigue based on clinically validated patient-reported outcomes (PROs). In addition, MS patients can add treatment information, from disease modifying therapies (DMTs) to symptomatic and rehabilitation treatments, and set reminders on when to take or perform their treatment. Furthermore, patients can easily upload their magnetic resonance imaging (MRI) scans (via the patient website) and view them (via the patient website and app) as well as learn about topics related to MS (e.g., MS types, MRI lesions). Finally, patients can prepare their consultations using a pre-visit checklist, the answers of which are also shared with the patient's clinical team. This study aims to evaluate the feasibility to use this app in a population of 100 MS patients in Antwerp, in three clinical centres. For this, the following objectives have been set forth:
  • - The primary objective is to evaluate the usability and acceptance of a digital remote monitoring solution for MS (icompanion).
  • - The secondary objectives are: 1.
To evaluate the relationship between MS patients' subjective health experience, disease control and disease acceptation (by using the Health Monitor) and adherence and usability. 2. To evaluate the impact of the use of the solution on the Health Monitor profile (reflecting patients' subjective health experience, disease control and disease acceptation) in a pre- versus post-intervention analysis. 3. To evaluate the impact of the solution on the MS patients' disease self-management, by use of the Multiple Sclerosis Self-Management Scale-Revised (MSSM-R) 4. To evaluate the impact of the solution on the clinical visit workflow, by using visual analogue scales with custom questions about impact on workflow.
  • - The tertiary objectives are: 1.
To evaluate the concordance between patient-reported and clinician-assessed values of some of the parameters collected by the icompanion default dataset (e.g., patient-reported Expanded Disability Status Scale (EDSS), daily steps), when available. 2. To evaluate the app features most used by patient users. 3. To evaluate the web portal features most used by HCP users

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. A diagnosis of multiple sclerosis (MS, including relapsing-remitting MS, primary-progressive MS and secondary-progressive MS, in accordance with 2017 revisions of McDonald criteria and disease course definitions of Lublin, 2. Age 18 or above, 3. Able to give informed consent (written or verbal with witness signing on behalf of patient) and to adhere to study procedures, 4. Dutch/Flemish speaking.

Exclusion Criteria:

1. Unable or unwilling to use the smartphone-based icompanion app. 2. Prior use of the icompanion app.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06179758
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Antwerp
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Arms & Interventions

Arms

Experimental: open-label interventional arm

Interventions

Device: - icompanion app

use of the icompanion app as a digital telemonitoring solution

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Barbara Willekens, MD, PhD

[email protected]

+3238213426

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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