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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Many patients with multiple sclerosis (MS) experience "relapses" of disease activity during which they have increased numbness, weakness, visual problems, or other symptoms. If a person with MS has new symptoms that are concerning to them, their doctor may want to see them in the office in order to confirm that these symptoms are due to a true "relapse" of activity before starting relapse treatment. This requirement can be frustrating for patients, who may have to take time off from work or travel long distances for such unexpected doctors' visits. In this study, the investigators will use input from patients with MS and MS physicians to create a relapse questionnaire that can be used to confirm a relapse has occurred. The investigators will also evaluate if having a more direct line of communication with the provider's office improves overall patient care and satisfaction.

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 data supports the effectiveness of the treatment Communication with the clinic, Relapse Questionnaire for multiple sclerosis?

Research shows that providing patients with evidence-based information and education on relapse management can lead to more informed decisions and better management of relapses. Additionally, developing communication tools in collaboration with healthcare professionals can improve the standard of care for people with multiple sclerosis. ^{1 2 3 4 5}

Is the Technology-Enhanced Communication for Multiple Sclerosis treatment safe for humans?

The safety of Technology-Enhanced Communication for Multiple Sclerosis, which includes tools like web-based programs and mobile apps for managing relapses, has not been directly addressed in the available research. However, these tools are generally used to support decision-making and reporting, rather than being a direct medical treatment, suggesting they are likely safe for human use. ^{3 6 7 8 9}

How is the Technology-Enhanced Communication treatment for multiple sclerosis different from other treatments?

This treatment is unique because it uses digital technology to enhance communication and self-management for multiple sclerosis patients, incorporating tools like video calling and e-health interventions to improve disease monitoring and patient education, which is not typically a focus in standard treatments. ^{8 10 11 12 13}

Research Team

Ellen Mowry

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Summary of Research: Collaboration Between Healthcare Professionals and People with Multiple Sclerosis to Develop Communication Tools to Improve the Standard of Multiple Sclerosis Care. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Multiple Sclerosis and MyChart Messaging: A Retrospective Chart Review Evaluating Its Use. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)-study protocol for a randomised controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Improving reporting of multiple sclerosis relapse. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Training physicians in providing complex information to patients with multiple sclerosis: a randomised controlled trial. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Adherence to monthly online self-assessments for short-term monitoring: a 1-year study in relapsing-remitting multiple sclerosis patients after start of disease modifying treatment. [2021]

7. New Zealand 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Patient- versus physician-reported relapses in multiple sclerosis: insights from a large observational study. [2021]

9. England 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. [2019]

10. England pubmed.ncbi.nlm.nih.gov

MSmonitor-plus program and video calling care (MPVC) for multidisciplinary care and self-management in multiple sclerosis: study protocol of a single-center randomized, parallel-group, open label, non-inferiority trial. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review. [2021]

12. England pubmed.ncbi.nlm.nih.gov

The 'Impact on Participation and Autonomy': acceptability of the English version in a multiple sclerosis outpatient setting. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Demographic Patterns of MS Patients Using BRISA: An MS-Specific App in Germany. [2022]