Digital Monitoring App for Myasthenia Gravis

Recruiting at 16 trial locations

Overseen By Pr Laforet

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ad scientiam

Disqualifiers: Thymectomy, Plasma Exchange, Immunoglobulin, others

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

Compensation: Varies

Number of Visits: 4

144 Participants Needed

Trial Summary

What is the purpose of this trial?

ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It seems focused on using a digital app for monitoring symptoms, so you might not need to change your medication routine, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the Digital Monitoring App for Myasthenia Gravis treatment?

Research shows that using digital tools like mobile applications for myasthenia gravis can help improve patient care by allowing early detection of symptoms, reducing unnecessary doctor visits, and enhancing communication between patients and doctors. This can lead to better management of the condition and improve patients' quality of life. ^{1 2 3 4 5}

Is the Digital Monitoring App for Myasthenia Gravis safe for use in humans?

There is no specific safety data available for the Digital Monitoring App for Myasthenia Gravis, but mobile health applications in general are being studied for their ability to safely communicate adverse drug reactions between patients and healthcare providers. ^{6 7 8 9 10}

What makes the ME&MG Digital Solution treatment unique for myasthenia gravis?

The ME&MG Digital Solution is unique because it uses a mobile app to help manage myasthenia gravis by allowing patients to record symptoms, set medication reminders, and communicate with their doctors online, which can improve quality of life and reduce healthcare costs. ^{1 3 11 12 13}

Eligibility Criteria

This trial is for adults aged 18-60 with Myasthenia Gravis, who have general muscle weakness but are unlikely to need a respirator. Participants must test positive for anti-AChR autoantibodies, own a compatible smartphone, and be able to use the ME&MG app in English, French or Spanish. Pregnant women, those under legal supervision, with recent substance abuse or involved in other studies that could affect this one cannot join.

Inclusion Criteria

Able to use a smartphone

Own a personal smartphone which software version is above 13 for iOS and 8 for Android included

I can read and understand French, English, or Spanish and can understand pictograms.

Exclusion Criteria

Participant included in another ME&MG clinical study

Participant has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the subject's full participation in the study or confound the assessment of the subject or outcome of the study

Pregnant and nursing women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial in-clinic assessment and baseline data collection

1 day

1 visit (in-clinic)

Treatment Follow-up

Participants use the ME&MG app at-home for self-assessment and monitoring of symptoms

12 months

3 visits (in-clinic) for MG patients, 1 visit (in-clinic) for healthy volunteers

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ME&MG Digital Solution

Trial Overview The ME&MG mobile application is being tested as an at-home self-assessment tool for monitoring disabilities caused by Myasthenia Gravis. The study aims to validate the app's accuracy compared to standard clinic tests and evaluate its safety and user satisfaction.

Participant Groups

Group I: MG patients Experimental Treatment 1 Intervention

MG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months

Group II: Healthy volunteers Experimental Treatment 1 Intervention

Healthy volunteers will perform one in-clinic visit and will use the app at-home once

Who Is Running the Clinical Trial?

Ad scientiam

Lead Sponsor

Trials

12

Recruited

1,500+

Findings from Research

The COVID-19 pandemic has necessitated a shift in healthcare delivery for patients with chronic neurological diseases like myasthenia gravis (MG), highlighting the need for early detection of disease worsening and complications.

The study proposes an online evaluation protocol using four simple tests, leveraging telemedicine and digital technology to enhance MG management and reduce the need for in-person consultations during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myasthenia gravis and telemedicine: a lesson from COVID-19 pandemic. Ricciardi, D., Casagrande, S., Iodice, F., et al.[2022]

A study involving 58 patients with myasthenia gravis (MG) identified limb weakness as the most impactful symptom, while side effects like weight gain and mood swings were the most bothersome, highlighting the need for treatments with minimal adverse effects.

The Myasthenia Gravis Quality of Life-Revised (MG-QOL15R) scale was chosen as the primary patient-centered outcome measure for the PROMISE-MG trial, emphasizing the importance of patient input in evaluating treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying a patient-centered outcome measure for a comparative effectiveness treatment trial in myasthenia gravis. Narayanaswami, P., Sanders, DB., Bibeau, K., et al.[2022]

An expert panel developed a comprehensive application for myasthenia gravis (MG) management, which includes features like medication tracking, symptom recording, and alerts for healthcare providers, aimed at improving patient care and safety.

Neurologists rated the application's usability highly (average score of 8.23 out of 9), indicating strong support for its potential to enhance patient quality of life and healthcare efficiency in managing MG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability monitoring of patients with myasthenia gravis using a mobile-based application. Alaei Tafti, E., Ghazisaeedi, M., Sarraf, P.[2023]

A total of 1,711 requests for advice were analyzed from patients with Myasthenia Gravis, revealing that 47% of inquiries to the German Myasthenia Gravis Association (DMG) were related to medical issues, particularly concerning medication side effects and treatment questions.

The study highlights a significant demand for timely advice among MG patients, suggesting that implementing standardized responses and modern digital communication tools, like telemedicine, could improve the efficiency of addressing patient inquiries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myasthenia gravis - a retrospective analysis of e-mail inquiries made to a patient organisation and specialized center to uncover unmet needs from patients and caregivers. Stein, M., Hoffmann, S., Gerischer, L., et al.[2023]

The virtual Myasthenia Gravis Impairment Index (vMGII) effectively correlates with other patient-reported outcomes, demonstrating its utility in assessing disease status during telephone consultations for 214 myasthenia gravis patients.

A vMGII score of 11.5 or higher reliably predicts a positive response on the Patient-Acceptable Symptom State (vPASS), with a sensitivity of 78.7% and specificity of 81.4%, indicating its effectiveness in monitoring disease progression even without in-person evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone consultation for myasthenia gravis care during the COVID-19 pandemic: Assessment of a novel virtual myasthenia gravis index. Menon, D., Alnajjar, S., Barnett, C., et al.[2023]

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 European Academy of Allergy and Clinical Immunology's task force reviewed the potential of mobile health (mHealth) technologies to enhance patient care in allergology, emphasizing their role in supporting self-management and improving health services for allergic diseases.

The task force highlighted the importance of user engagement, design, and privacy policies in mHealth products, suggesting that effective mHealth solutions could shift the focus from clinician-centered to patient-centered care in managing allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of mobile health technologies in allergy care: An EAACI position paper. Matricardi, PM., Dramburg, S., Alvarez-Perea, A., et al.[2021]

A survey of 480 patients and 31 general practitioners (GPs) revealed that while 56% of patients and 42% of GPs were willing to use mobile health (mHealth) applications for reporting adverse drug reactions (ADRs), willingness decreased with age for both groups.

Patients valued rapid feedback on consultation urgency, while GPs preferred information on medication administration difficulties; however, barriers included older patients' preference for personal contact with their GP and GPs' concerns about time and resource demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Mobile Health Application to Communicate Adverse Drug Reactions - Preconditions, Assessment of Possible Functionalities and Barriers for Patients and Their General Practitioners. Wakob, I., Schmid, GL., Nöhring, I., et al.[2022]

The SmartVax system successfully engaged over 70% of vaccinated patients through SMS to report adverse events following immunization (AEFI), demonstrating its effectiveness in active monitoring.

Of the respondents, 11.3% reported possible AEFI, indicating that SMS-based surveillance can provide timely data to complement traditional passive reporting systems for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. Leeb, A., Regan, AK., Peters, IJ., et al.[2022]

A review of 138 incident reports from users of electronic health records in Finland revealed that vulnerabilities in these systems can lead to serious harm across various healthcare settings.

The low rate of reported incidents suggests significant challenges in the oversight of medical software and highlights potential barriers to effective reporting of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors. Palojoki, S., Saranto, K., Lehtonen, L.[2020]

The MG-ADL profile, a patient-reported scale for myasthenia gravis, shows strong correlations with established measures like the Quantitative MG score and the MG Composite, indicating its effectiveness in assessing symptoms and their impact on daily activities.

A 2-point improvement on the MG-ADL scale is a reliable indicator of clinical improvement, making it a valuable tool for both clinical management and as a secondary outcome measure in trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The myasthenia gravis--specific activities of daily living profile. Muppidi, S.[2019]

Myasthenia gravis (MG) affects approximately 20 per 100,000 people in the U.S. and is characterized by muscle weakness and fatigue due to a defect at the neuromuscular junction.

The American Association of Neuroscience Nurses' Clinical Practice Guideline provides comprehensive evidence-based recommendations for nursing management of MG, covering aspects like diagnosis, treatment options, and the critical role of nurses in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice guideline series update. Blissitt, PA.[2013]

A group of experts has established consensus recommendations to standardize outcome measures in clinical trials for myasthenia gravis (MG), addressing variability that can affect trial data reliability.

Key changes were made to several assessment tools, including the MG-Activities of Daily Living and the Quantitative MG (QMG) score, to improve clarity and consistency in their administration, with further validation studies planned for the revised QMG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Outcome Measure Variability in Myasthenia Gravis Clinical Trials. Guptill, JT., Benatar, M., Granit, V., et al.[2023]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Myasthenia gravis and telemedicine: a lesson from COVID-19 pandemic. [2022]

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

Identifying a patient-centered outcome measure for a comparative effectiveness treatment trial in myasthenia gravis. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

Stability monitoring of patients with myasthenia gravis using a mobile-based application. [2023]

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

Myasthenia gravis - a retrospective analysis of e-mail inquiries made to a patient organisation and specialized center to uncover unmet needs from patients and caregivers. [2023]

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

Telephone consultation for myasthenia gravis care during the COVID-19 pandemic: Assessment of a novel virtual myasthenia gravis index. [2023]

6. 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]

7. Denmark pubmed.ncbi.nlm.nih.gov

The role of mobile health technologies in allergy care: An EAACI position paper. [2021]

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

Developing a Mobile Health Application to Communicate Adverse Drug Reactions - Preconditions, Assessment of Possible Functionalities and Barriers for Patients and Their General Practitioners. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. [2022]

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

Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors. [2020]

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

The myasthenia gravis--specific activities of daily living profile. [2019]

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

Clinical practice guideline series update. [2013]

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

Addressing Outcome Measure Variability in Myasthenia Gravis Clinical Trials. [2023]