icompanion app
Deviceuse of the icompanion app as a digital telemonitoring solution
NCT Number: NCT06179758
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
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
University Hospital Antwerp, Edegem, Antwerpen, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
use of the icompanion app as a digital telemonitoring solution
Time frame: month 2, month 6, month 12
measurement variable: adherence number (adherence defined as use of the icompanion app minimally once a month, score between 0 and 100%)
Time frame: 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)
measurement variable: system usability scale (10 questions, score between 10 and 50, with higher scores meaning a better usability)
Time frame: month 0, month 2, month 6, month 12
the correlation between an individual's Health Monitor segment (4-segment segmentation approach based on a short questionnaire of 6 questions, reflecting an individual's sense of control and acceptance) and his/her adherence and estimation of the usability of the icompanion app (using the system usability scale (10 questions, score between 10 and 50, with higher scores meaning a better usability) will be assessed
Time frame: month 0, month 2, month 6, month 12
the evolution of an individual's Health Monitor segment (4-segment segmentation approach based on a short questionnaire of 6 questions, reflecting an individual's sense of control and acceptance) before and after use of the icompanion app
Time frame: month 0, month 2, month 6, month 12
measurement variable: Multiple Sclerosis Self-Management Scale-Revised (MSSM-R, 24 questions, score between 24 and 120, with higher scores meaning a higher degree of disease self-management)
Time frame: 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)
measurement variable: visual analogue scales with custom questions about impact on clinical visit (5 questions, score between 5 and 25, with higher scores meaning a better impact on the clinical visit workflow)
Time frame: continuously throughout the study, for an estimated duration of 6 to 12 months
measurement variable: icompanion dataset (e.g., patient-reported Expanded Disability Status Scale (EDSS), score from 0 to 10, with lower scores meaning less disease-related signs and symptoms)
Time frame: continuously throughout the study, for an estimated duration of 6 to 12 months
measurement variable: usage rate of the individual app features
Time frame: continuously throughout the study, for an estimated duration of 6 to 12 months
measurement variable: usage rate of the individual features of the icompanion web portal
University Hospital, Antwerp
Other
Acronym: ReMSCA
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