Clinical effects on disease severity and quality of life of myasthenia gravis patients based on telemedical treatment with point-of-care diagnostics in the integrated myasthenia center (iMZ) - a pilot study

Not Applicable

• Conditions: G70.0; Myasthenia gravis

• Registration Number: DRKS00029907
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-19
• Study Completion: 2023-09-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Participants must suffer from myasthenia gravis (ICD-10: G70.0), the diagnosis must have existed for at least 6 months
Participants must be treated in the iMZ of the Charité Berlin
Participants must communicate in German without an interpreter
Age of majority, minimum age 18 years

Exclusion Criteria

Organic brain diseases (ICD-10: F0x)
Intellectual disability (ICD-10: F7x)
Physical illnesses with limitations that make regular participation and data entry via a smartphone impossible
Inability to conduct the study and understand the risks involved
Patients with a somatic, psychiatric or neurological disease or treatment that can impair cognitive functions or are not stable under drug treatment and could have an impact on the parameters to be examined.
Patients who do not have a smartphone or tablet (operating system requirement at least iOS 14 or Android 9).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of adherence to the entry of ePROMs (electronic Patient Reported Outcome Measures) and collection of vital parameters by the participants by measuring the proportion of actual entries compared to the planned queries over a period of three months.

Secondary Outcome Measures

Name	Time	Method
Assessment of usability (System Usability Scale),<br>drop out rate,<br>Myasthenia gravis Activities of Daily Living,<br>Myasthenia gravis quality of daily living,<br>Quantitative myasthenia gravis score,<br>Patient Health Questionnaire,<br>Chalder Fatigue Scale,<br>Hospital anxiety and depression scale,<br>Absolute number of hospital stays (normal ward, intensive care ward) during the intervention period,<br>Absolute number of rescue center contacts