Burden of Disease in Myasthenia Gravis (Mya-BoD)
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|ClinicalTrials.gov Identifier: NCT03979521|
Recruitment Status : Active, not recruiting
First Posted : June 7, 2019
Last Update Posted : August 9, 2019
|Condition or disease|
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.
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:
- 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.
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
|Study Type :||Observational|
|Actual Enrollment :||1680 participants|
|Official Title:||Questionnaire Survey on the Systematic Recording and Characterization of Quality of Life Limitations in Myasthenia Gravis|
|Actual Study Start Date :||May 1, 2019|
|Actual Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information socioeconomic situation [ Time Frame: directly after inclusion in the study ]
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: directly after inclusion in the study ]Questionnaire for self-completion by patients to determine the levels of anxiety and depression
- Mya Quality of Life 15 (Mya QoL15) [ Time Frame: directly after inclusion in the study ]Questionnaire for self-completion by patients for use as a measure of health outcome
- Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF36) [ Time Frame: directly after inclusion in the study ]Questionnaire for self-completion by patients for patients health
- Myasthenia gravis Activities of daily living (MG ADL) [ Time Frame: directly after inclusion in the study ]Questionnaire for self-completion by patients to determine symptom severity and limitations in activities of daily living
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979521
|NeuroCure Clinical Research Center (NCRC), Charité University, Berlin|
|Principal Investigator:||Andreas Meisel, Prof. Dr. med.||Charite University, Berlin, Germany|