Technology-Enhanced Communication for Multiple Sclerosis

Overseen By Ellen Mowry

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Interferon beta, Glatiramer acetate, Fingolimod, Teriflunomide

Disqualifiers: DMT exposure, Therapy change, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 96 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to ease life for people with multiple sclerosis (MS) by improving communication with their healthcare providers. Researchers are testing a new tool, the Relapse Questionnaire, to confirm MS relapses (times when symptoms worsen) without requiring an in-person visit. The goal is to determine if this approach can enhance patient care and satisfaction. Individuals with relapsing-remitting MS, who have experienced certain recent symptoms, and live within 100 miles of Johns Hopkins Medical Center might be suitable candidates. Participants will need a smartphone or must be open to using one provided for the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative methods that could improve MS care for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be starting specific MS therapies, so you might need to switch to one of those.

What prior data suggests that this communication method is safe for patients with multiple sclerosis?

Research has shown that technology-based communication tools are generally safe for people with multiple sclerosis. Many digital health solutions function effectively without causing major safety issues. For example, they help doctors monitor symptoms remotely and improve patient health. Studies have not reported any serious negative effects from using these tools.

These technologies often enhance condition management by providing reliable ways to track symptoms and communicate with healthcare providers. Patients typically handle these digital tools well, without experiencing harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how technology-enhanced communication can improve care for people with Multiple Sclerosis (MS). Unlike standard treatments that focus on medication, this approach aims to enhance the way patients interact with their healthcare providers. The trial examines whether a new method of communication can help in better tracking and managing MS relapses. By potentially improving communication, the goal is to provide more personalized and timely interventions, leading to better overall management of the condition.

What evidence suggests that this trial's methods could be effective for multiple sclerosis?

Research has shown that digital technology can help people with multiple sclerosis (MS) communicate better and manage their condition. In this trial, participants in the experimental arm will experience a different kind of communication with the clinic, which may help catch early signs of the disease. Another review showed that these digital tools can improve health from the patient's perspective. Additionally, a study on digital care pathways found that they can boost mental health for those dealing with long-term conditions like MS. These findings suggest that using technology in MS care might make managing the condition easier. ^{1 6 7 8 9}

Who Is on the Research Team?

Ellen Mowry

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with relapsing-remitting MS who have had at least two relapses in the past two years or one recent onset of RRMS. Participants must own a smartphone or be willing to use one, live within 100 miles of Johns Hopkins Medical Center, and have an EDSS score of 6.0 or less.

Inclusion Criteria

My disability level allows me to walk at least 100 meters without aid or rest.

English speakers

Possession of a smartphone OR of a mobile telephone with text messaging AND an e-mail account AND web access OR willingness to be provided with, and utilize, a smartphone for the duration of the study

Exclusion Criteria

I have changed my MS therapy after my last relapse or MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a different kind of communication with the clinic to evaluate the effectiveness of a relapse questionnaire and direct communication

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Communication with the clinic
• Relapse Questionnaire

Trial Overview The study aims to develop a questionnaire that can confirm MS relapses without needing an office visit. It will also assess if better communication with healthcare providers via technology improves patient care and satisfaction.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

A different kind of communication with the clinic will be used.

Group II: Control Active Control 1 Intervention

One kind of communication with the clinic will be used.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Biogen

Industry Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Published Research Related to This Trial

The REGIMS registry is a multicenter observational study in Germany that collects data on the side effects of immunotherapies for multiple sclerosis, providing valuable insights into the long-term safety of these treatments.

By the end of 2019, REGIMS had recruited 1000 patients, primarily women with relapse-remitting MS, demonstrating the registry's ability to gather high-quality, real-world data despite facing logistical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry. Simbrich, A., Thibaut, J., Khil, L., et al.[2022]

Digital technology tools are increasingly being integrated into clinical trials for multiple sclerosis (MS), enhancing treatment delivery and disease monitoring through methods like psychotherapy apps and robot-assisted exercises.

These technologies improve the standardization of outcome measures and enable better detection of symptoms and treatment adherence, shifting data collection from traditional paper-based methods to more efficient internet-based systems, which can also facilitate remote rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review. De Angelis, M., Lavorgna, L., Carotenuto, A., et al.[2021]

A study is being conducted to test whether a mobile application can significantly increase the reporting of adverse drug reactions (ADRs) among patients with relapsing-remitting multiple sclerosis (RR-MS) who are using disease-modifying drugs (DMDs).

The trial aims to enroll 180 patients across 24 centers, with the expectation that the app will boost ADR reporting by ten times compared to traditional methods, highlighting the importance of patient involvement in monitoring drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Defer, G., Le Caignec, F., Fedrizzi, S., et al.[2019]

The BRISA app, used by 2095 multiple sclerosis patients in Germany, revealed that most users are female and aged between 26 and 55, with relapsing-remitting MS being the most common type.

The study identified fatigue, concentration disorders, tingling, forgetfulness, and pain as the top symptoms affecting users, emphasizing the need for personalized disease management strategies based on real-world data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic Patterns of MS Patients Using BRISA: An MS-Specific App in Germany. Balakrishnan, P., Groenberg, J., Jacyshyn-Owen, E., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-multiple-sclerosis-6-2018-8d08d

Technology-Enhanced Communication for Multiple Sclerosis This treatment is unique because it uses digital technology to enhance communication and self-management for multiple sclerosis patients, incorporating tools ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687804/

Mobile health interventions in multiple sclerosis: A systematic ... Analysis of the evidence of digital health applications to improve health outcomes from a patient perspective. Methods: A systematic review ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399122003366

Communication between persons with multiple sclerosis ... This study undertakes a scoping review of research about communication between persons with MS and their health care providers.

4. humanfactors.jmir.org humanfactors.jmir.org/2024/1/e51872/

Effects of a Digital Care Pathway for Multiple Sclerosis Psychological health was enhanced during the use of MS DCP. Our results indicate that DCPs hold great promise for managing chronic conditions ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8773844/

Digital Innovation in Multiple Sclerosis Management - PMC Digital innovations may provide a solution to the problem of how we can avoid missing disease activity. Mäcken et al. developed a digital ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5941090/

The Use of Digital and Remote Communication Technologies ... Many eHealth solutions have been shown to be effective in improving outcomes, in facilitating remote monitoring of symptoms, and in increasing ...

7. mscare.org mscare.org/multiple-sclerosis-new-technology-improves-cognition/

Multiple Sclerosis – New Technology Improves Cognition A new technology called transcranial direct current stimulation (tDCS) has been recently shown to improve some of the symptoms of MS.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8199078/

Digital Technology in Clinical Trials for Multiple Sclerosis The Neurostatus E-Scoring App on iPad improved EDSS inter-rater reliability (with a reduction of inconsistencies from 32% to 1.5% during study ...

9. pxjournal.org pxjournal.org/cgi/viewcontent.cgi?article=2031&context=journal

A Qualitative Study on Communication and Cultural ... Objective: E ective communication is crucial in multiple sclerosis (MS) care, in uencing patient satisfaction, self-management, and health ...