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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03979521
Other study ID # Mya-BoD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date July 31, 2019

Study information

Verified date December 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Questionnaire-based survey addressed to german patients with the chronic autoimmune muscle disease called myasthenia gravis regarding quality of life, socioeconomic impact, social support, course of disease, complications of therapy and psychological comorbidities.


Description:

Background: Myasthenia gravis is a rare, chronic, antibody-mediated autoimmune disease that results in muscular weakness. The patients suffer from symptoms such as visual disturbances (especially double vision), weakness in the arms and legs, chewing and swallowing disorders and respiratory disorders, as well as crisis-related worsening of ventilation. This is often accompanied by pronounced fatigue (physical) and mental fatigue (depression). Despite drug therapies that are on one hand symptomatic improving muscle strength, and on the other hand modulating the immune system, as well as specific procedures and drugs used in crises (plasmapheresis, immunoglobins) or refractory patients, patients are often severely limited, affecting everyday activities of self-care, family, social and professional life, thus affecting the mood and quality of life of patients. There is a lack of data measuring quality of life adequately. Aim: The aim of the data collection is to record the quality of life of myasthenia patients. By clinical information on the disease (including symptoms, course and therapy) and recording the social and occupational situation, the data should be contextualized. The following hypotheses are to be confirmed: Primary hypotheses - Myasthenia gravis affects the quality of life of patients comparable to neurological diseases such as multiple sclerosis - Patients are limited in their participation in their private and professional life - The severity of the disease is associated with the quality of life. Secondary hypotheses - Myasthenia is associated with income busses and other economic disadvantages of the night - Quality of life in myasthenia patients is related to fatigue and depression - Quality of life in myasthenia patients depends on different therapy methods - Myasthenia gravis has an impact on family planning and care for children. Methods: In cooperation with the German Myasthenia Gravis Society, a questionnaire prepared by the Charité will be sent to its members with a request for completion and an anonymous return. Similar projects have already been implemented in the past (response rate> 30%). About 3,300 patients should be contacted. The returned questionnaires are then statistically evaluated and presented as part of a publication. For the evaluation of the hypotheses suitable descriptive, univariate analysis methods are used. Furthermore, with sufficient case numbers, multivariate analyzes (e.g., logistic regression) are also planned. The questionnaire contains general information and questions about: - Education and employment - Social situation - Social Support - Economic aspects - Symptoms and severity, course, treatment of myasthenia - Quality of life - Fatigue and depression


Recruitment information / eligibility

Status Completed
Enrollment 1680
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with Myasthenia Gravis - Age =18 years Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany NeuroCure Clinical Research Center (NCRC), Charité University, Berlin Berlin-Mitte

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lehnerer S, Jacobi J, Schilling R, Grittner U, Marbin D, Gerischer L, Stascheit F, Krause M, Hoffmann S, Meisel A. Burden of disease in myasthenia gravis: taking the patient's perspective. J Neurol. 2021 Nov 20. doi: 10.1007/s00415-021-10891-1. [Epub ahea — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information socioeconomic situation directly after inclusion in the study
Primary Hospital Anxiety and Depression Scale (HADS) Questionnaire for self-completion by patients to determine the levels of anxiety and depression directly after inclusion in the study
Primary Mya Quality of Life 15 (Mya QoL15) Questionnaire for self-completion by patients for use as a measure of health outcome directly after inclusion in the study
Primary Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF36) Questionnaire for self-completion by patients for patients health directly after inclusion in the study
Primary Myasthenia gravis Activities of daily living (MG ADL) Questionnaire for self-completion by patients to determine symptom severity and limitations in activities of daily living directly after inclusion in the study
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