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