Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Part… (NCT05949580) | Clinical Trial Compass
RecruitingNot Applicable
Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
United States, Germany500 participantsStarted 2024-10-21
Plain-language summary
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.
This is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. To use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (Android version 5.0 or above, iOS version 11 or above)
* Have a valid email address (for registration of icompanion ms)
* Have a definite diagnosis of RRMS
* Time since MS diagnosis ≥1 year
* Medical history recorded for at least 1 year before enrollment
* Expanded Disability Status Scale (EDSS) \<5.5
Exclusion Criteria:
* Any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion
* Inability to complete an MRI
* Currently involved in an interventional trial
* Diagnosis of progressive MS (primary progressive multiple sclerosis \[PPMS\] or secondary progressive multiple sclerosis \[SPMS\])
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6
Timeframe: Month 6
2
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 12
Timeframe: Month 12
3
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 24
Timeframe: Month 24
4
Participants: Median Score of the mHealth App Usability Questionnaire (MAUQ) [MAUQ_E (Ease of Use) MAUQ_I (Interface and Satisfaction)] at Baseline
Timeframe: Baseline
5
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 12
Timeframe: Month 12
6
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 24
Timeframe: Month 24
7
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by Semi-structured Interviews (SSIs) at Month 6