Burden of Disease in Myasthenia Gravis (Mya-BoD)

December 15, 2021 updated by: Andreas Meisel, Charite University, Berlin, Germany

Questionnaire Survey on the Systematic Recording and Characterization of Quality of Life Limitations in Myasthenia Gravis

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.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

1680

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin-Mitte, Germany
        • NeuroCure Clinical Research Center (NCRC), Charité University, Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Myasthenia Gravis being member at the German myasthenia gravis socitey (Deutsche Myasthenie Gesellschaft)

Description

Inclusion Criteria:

  • Patients with Myasthenia Gravis
  • Age ≥18 years

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
directly after inclusion in the study
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
directly after inclusion in the study
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
directly after inclusion in the study
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
directly after inclusion in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

NeuroCure Clinical Research Center, Charite, Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mya-BoD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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