Clinical trial NCT06179758: Remote MS Care in Antwerp
Official title: Remote MS Care in Antwerp
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: remote monitoring
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag div. of Johnson&Johnson SE
name: icometrix
name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: AZ Klina
First posted: 2023-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: the acceptance of a digital remote monitoring solution for MS (icompanion) (adherence number)
timeFrame: month 2, month 6, month 12
measure: the usability of a digital remote monitoring solution for MS (icompanion)
timeFrame: month 2, month 6, month 12 (for patients), clinical visit 1 and 2 (for health care professionals, visit 1 between three to six months following inclusion and visit 2 between six to twelve months following inclusion, depending on individual follow-up)
Secondary outcomes:
measure: the correlation between MS patients' subjective health experience, disease control and disease acceptation (by using the Health Monitor) and adherence and usability
timeFrame: month 0, month 2, month 6, month 12
measure: 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
timeFrame: month 0, month 2, month 6, month 12
measure: the impact of the use the solution on the MS patients' disease self-management, by use of the MSSM-R
timeFrame: month 0, month 2, month 6, month 12
measure: the impact of the solution on the clinical visit workflow, by using visual analogue scales with custom questions about impact on workflow
timeFrame: clinical visit 1 and 2 clinical visit 1 and 2 (for patients and health care professionals, visit 1 between three to six months following inclusion and visit 2 between six to twelve months following inclusion, depending on individual follow-up)
Other outcomes:
measure: the concordance between patient-reported and clinician-assessed values of some of the parameters collected by the icompanion default dataset, when available
timeFrame: continuously throughout the study, for an estimated duration of 6 to 12 months
measure: the app features most used by patient users
timeFrame: continuously throughout the study, for an estimated duration of 6 to 12 months
measure: the web portal features most used by health care professional users
timeFrame: continuously throughout the study, for an estimated duration of 6 to 12 months
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerpen
Study officials:
References: