Digital Monitoring App for Myasthenia Gravis
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ad scientiam
Disqualifiers: Thymectomy, Plasma Exchange, Immunoglobulin, others
No Placebo Group
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.
12345Is 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.
678910What 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.
13111213Eligibility 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.
+4 more
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
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: MG patientsExperimental Treatment1 Intervention
MG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months
Group II: Healthy volunteersExperimental Treatment1 Intervention
Healthy volunteers will perform one in-clinic visit and will use the app at-home once
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University HealthIndianapolis, IN
University of Florida HealthJacksonville, FL
University of KentuckyLexington, KY
Neurological Associates of Long Island, P.C.Lake Success, NY
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Who Is Running the Clinical Trial?
Ad scientiamLead Sponsor
References
Myasthenia gravis and telemedicine: a lesson from COVID-19 pandemic. [2022]COVID-19 pandemic has induced an urgent reorganization of the healthcare system to ensure continuity of care for patients affected by chronic neurological diseases including myasthenia gravis (MG). Due to the fluctuating nature of the disease, early detection of disease worsening, adverse events, and possibly life-threatening complications is mandatory. This work analyzes the main unresolved issues in the management of the myasthenic patient, the possibilities offered so far by digital technologies, and proposes an online evaluation protocol based on 4 simple tests to improve MG management. Telemedicine and Digital Technology might help neurologists in the clinical decision-making process of MG management, avoiding unnecessary in presence consultations and allowing a rational use of the time and space reduced by the pandemic.
Identifying a patient-centered outcome measure for a comparative effectiveness treatment trial in myasthenia gravis. [2022]Data regarding the comparative effectiveness of myasthenia gravis (MG) treatments is not available. We used patient input to identify a patient-centered outcome measure (PCOM) for PROMISE-MG, a comparative effectiveness trial of MG treatments.
Stability monitoring of patients with myasthenia gravis using a mobile-based application. [2023]Background: Failure in early diagnosis of myasthenia gravis (MG) and the risks of taking certain medications and undergoing surgery and anesthesia can lead to severe respiratory disorders and death. However, there are therapeutic measures that significantly control the disease and improve individual's functionality. Methods: First, an expert panel was formed, and a needs assessment questionnaire was prepared for the information elements and the capabilities required for the application and provided to neurologists with a subspecialty fellowship in neuromuscular diseases. Then, based on the analyzed results, the application was designed and created in 2 versions (physician and patient), and in 2 languages (Persian and English). Eventually, a questionnaire for user interaction and satisfaction was provided to 5 relevant physicians to evaluate the application. Results: The results showed that neurologists considered all items of the needs assessment questionnaire to be 100% essential. The capabilities of the application included registering the medication name and dose, recording symptoms and complaints by the patient, completing standard questionnaires, online chat, medication reminder, sending alerts to the doctor when the patient is unwell, and providing a variety of reports. The usability evaluation showed that neurologists evaluated the application at a good level with the average score of 8.23 ± 0.47 (out of 9 points). Conclusion: In the long run, using this technology can reduce costs, improve patients' quality of life (QOL) and health care, change health behaviors, and ultimately, improve individual's health.
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]Myasthenia Gravis requires expert treatment from specialized neurologists. In Germany, this treatment is mainly provided by 18 Integrated Myasthenia Centers (iMZ) accredited by the German Myasthenia Gravis Association (DMG). The DMG is a large and well-organized patient organisation that is regarded as a trusted source for disease-specific information. The aim of this study was to analyse the type of requests that each of these institutions receives in order to identify any potential unmet needs regarding the availability of advice for patients and caregivers. This data can then be used in further research to tailor modern digital communication tools to the specific needs of MG patients.
Telephone consultation for myasthenia gravis care during the COVID-19 pandemic: Assessment of a novel virtual myasthenia gravis index. [2023]The aim of the study was to determine the association between the virtual Myasthenia Gravis Impairment Index (vMGII) with other patient-reported outcomes (PROs) of myasthenia gravis (MG) and its usefulness in telephone consultations with MG patients.
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]The reporting of adverse drug reactions (ADR) by patients represents an interesting challenge in the field of pharmacovigilance, but the reporting system is not adequately implemented in France. In 2015, only 20 MS patients in France reported ADR due to first-line disease-modifying drugs (DMD), while more than 3000 patients were initiated on DMD. The aim of this study is to validate a proof-of-concept as to whether the use of a mobile application (App) increases ADR reporting among patients with relapsing-remitting multiple sclerosis (RR-MS) receiving DMD.
The role of mobile health technologies in allergy care: An EAACI position paper. [2021]Mobile health (mHealth) uses mobile communication devices such as smartphones and tablet computers to support and improve health-related services, data and information flow, patient self-management, surveillance, and disease management from the moment of first diagnosis to an optimized treatment. The European Academy of Allergy and Clinical Immunology created a task force to assess the state of the art and future potential of mHealth in allergology. The task force endorsed the "Be He@lthy, Be Mobile" WHO initiative and debated the quality, usability, efficiency, advantages, limitations, and risks of mobile solutions for allergic diseases. The results are summarized in this position paper, analyzing also the regulatory background with regard to the "General Data Protection Regulation" and Medical Directives of the European Community. The task force assessed the design, user engagement, content, potential of inducing behavioral change, credibility/accountability, and privacy policies of mHealth products. The perspectives of healthcare professionals and allergic patients are discussed, underlining the need of thorough investigation for an effective design of mHealth technologies as auxiliary tools to improve quality of care. Within the context of precision medicine, these could facilitate the change in perspective from clinician- to patient-centered care. The current and future potential of mHealth is then examined for specific areas of allergology, including allergic rhinitis, aerobiology, allergen immunotherapy, asthma, dermatological diseases, food allergies, anaphylaxis, insect venom, and drug allergy. The impact of mobile technologies and associated big data sets are outlined. Facts and recommendations for future mHealth initiatives within EAACI are listed.
Developing a Mobile Health Application to Communicate Adverse Drug Reactions - Preconditions, Assessment of Possible Functionalities and Barriers for Patients and Their General Practitioners. [2022]Mobile health (mHealth) applications offer structured and timely communication between patients and general practitioners (GPs) about adverse drug reactions (ADR). Preconditions, functionalities and barriers should be studied to ensure safe implementation.
Using automated text messages to monitor adverse events following immunisation in general practice. [2022]To assess the performance of SmartVax, a prototypic active monitoring system for adverse events following immunisation (AEFI) using short message service (SMS) text messages and clinical data extracted from commercially available medical practice management software.
Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors. [2020]The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015. We identified 138 valid reports. Adverse events associated with electronic health record vulnerabilities, clustered around certain error types, cause serious harm and occur in all types of healthcare settings. The low rate of reported incidents raises questions about not only the challenges associated with medical software oversight but also the obstacles for reporting.
The myasthenia gravis--specific activities of daily living profile. [2019]The myasthenia gravis activities of daily living (MG-ADL) profile is an eight-item patient-reported scale developed to assess MG symptoms and their effects on daily activities. The MG-ADL profile correlated well with the Quantitative MG (QMG) score (r= 0.58, P
Clinical practice guideline series update. [2013]Approximately 20 per 100,000 people in the United States are currently living with myasthenia gravis (MG). MG is a chronic condition that occurs in all genders, ethnicities, and ages. The result of a defect at the neuromuscular junction, MG is characterized by fluctuating muscle weakness and fatigue. The purpose of the first edition of this American Association of Neuroscience Nurses' Clinical Practice Guideline is to summarize what is currently known about MG and to provide the reader with nursing-specific recommendations based on supporting evidence from nursing and other disciplines. Nursing Management of the Patient with Myasthenia Gravis includes information on epidemiology; types and classification of MG; pathophysiology; clinical features; clinical course; diagnostic tests; assessment; pharmacological, immunological, and surgical management; and the nurses' pivotal role in the care of the patient with MG.
Addressing Outcome Measure Variability in Myasthenia Gravis Clinical Trials. [2023]An increasing number of clinical trials are enrolling patients with myasthenia gravis (MG). A lack of standardization in the performance of outcome measures leads to confusion among site research teams and is a source of variability in clinical trial data. MGNet, the NIH-supported Rare Disease Clinical Research Network for MG, views standardization of MG outcome measures as a critical need. To address this issue, a group of experts summarized key outcome measures used in MG clinical trials and a symposium was convened to address issues contributing to outcome measure variability. Consensus recommendations resulted in changes to outcome measure instructions and, in some cases, modifications to specific instruments. Recommended changes were posted for public commentary before finalization. Changes to the MG-Activities of Daily Living, MG-Quality of Life-15r, and MG-Impairment Index were limited to adding details to the administration instructions. Recommendations for proper positioning of participants and how to score items that could not be performed because of non-MG reasons were provided for the MG Composite. The Quantitative MG (QMG) score required the most attention, and changes were made both to the instructions and the performance of certain items resulting in the QMG-Revised. The Postintervention Status was believed to have a limited role in clinical trials, except for the concept of minimal manifestation status. As a next step, training materials and revised source documents, which will be freely available to study teams, will be created and posted on the MGNet website. Further studies are needed to validate changes made to the QMG-Revised.