Myasthenia Gravis
Conditions
Keywords
Survey, Physical Activity, Fatigue
Brief summary
Danish patients with myasthenia gravis are asked to answer a validated and international questionnaire about physical activity. Also background questions about their disease and comorbidity are asked. To validate the data about physical activity from the questionnaires 69 patients are asked to wear an accelerometer for 7 days to measure activity level.
Detailed description
Secure digital mails are sent to around1500 patients qua their civil registration number (CPR number) (each resident of Denmark has a permanent unique civil registration number that is provided at birth or immigration to Denmark). The mail contains a link for the software REDCap (© 2018 Vanderbilt University), recommended by Rigshospitalet. REDcap is a secure web application for building and managing online surveys and databases. Patients are, in REDcap, informed about the project, and if interested, asked to sign the included informed content and answer six validated and translated questionnaires.
Interventions
BEHAVIORALAccelerometer measurements
To validate the questionnaires about physical activity, some patients will be wearing an accelerometer for one week. An accelerometer is a little device worn in a belt around the hip, which can measure intensity of the patient's activity level. The accelerometer is worn 24 hours a day for one week and is only removed when bathing.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Danish resident. * Alive. * Minimum age 18 years. * Registered in the Danish Patient Register with diagnosis code 70.0 (ICD-10) or 733.09 (ICD 8). * Subscribing E-boks (the Danish system for receiving secure digital emails).
Exclusion criteria
* I fulfilling the inclusion criteria, then no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Fatigue Inventory (MFI-20) | 5 minutes | MFI-20 is a self-reported questionnaire that measures fatigue severity. It contains 20 items and consists of five fatigue domains: mental fatigue, reduced motivation, reduced activity, physical fatigue and general fatigue. The response options consist of five check boxes ranging from Yes, that is true to No, that is not true. The scores in each domain range from 4 to 20, with higher scores indicating higher levels of fatigue. A total fatigue score for all five domains is not used. MFI-20 has been used in several clinical and healthy populations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The short International Physical Activity Questionnaire (IPAQ) | 3 minutes | IPAQ short form is used to measure self-reported time spent on physical activity and sedentary behavior. The questionnaire measures four intensity levels of physical activity from none (sedentary) to strenuous physical activity. Patients are asked to report number of hours and minutes per day on the different activity levels. |
| Insomnia Severity Index (ISI) | 3 minutes | ISI measures self-reported sleep quality and disturbances during the previous 2 weeks. The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 - 4 from less to more severe. The total score is the sum of each individual item and can range from 0 to 28 (28= most severe). |
| Myasthenia gravis activity of daily living profile (MG-ADL) | 10 minutes | Impact on daily living is assessed using the MG-ADL. An eight-question survey of symptoms severity, with each response graded from 0 (normal) to 3 (most severe). Questions include ocular, oropharyngeal, respiratory, and extremity functions. Total MG-ADL score ranges from 0 to 24. MG-ADL is also an indirect measurement of disease severity. |
| Myasthenia gravis quality of life 15-item score (MG-QoL15) | 3 minutes | MG -specific quality-of-life instrument is a 15-item questionnaire encompassing physical and psychological domains of MG to assess disease-specific Qol in MG patients. Rating consist of a 5-point scale ranging from 0 (not at all) to 4 (very much) as to the degree to which patients agree with the given statement summing up to a total score 0-60 points. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comorbidity | 5 seconds | Are you suffering from any of these conditions? (depression, any other psychiatric disorder, any auto-immune disease, chronic obstructive pulmonary disease, any cardiac diseases, chronic fatigue, sleep apnoea) |
| How many years diagnosed with MG? | 5 seconds | Number of years since diagnosis. |
| Symptoms of MG? | 5 seconds | The patient register symptoms according to the Myasthenia Gravis Foundation of American clinical classification. |
| Treatment for MG? | 5 seconds | The patient report their pharmacological treatment for MG. |
| Are you receiving immunoglobulin treatment or plasmaphereses? | 5 seconds | Answer yes/no. |
| Have you had a thymectomy? | 5 seconds | Answer yes/no. |
| Gender | 5 seconds | Are you a woman or a man? |
| Are you reguarly seen by a neurologist? | 5 seconds | Answer yes/no |
| How tall are you? | 2 seconds | Answer in centimeter |
| How much do you weight? | 2 seconds | Answer in kilograms |
| Are you living alone? | 2 seconds | Yes/no |
| Do you live with children? How many? | 2 seconds | Answer in number of children |
| Was is your highest education level? | 2 seconds | Short/middle/high education level |
| Are you having any of these treatments? | 5 seconds | The patient answer yes or no to the following treatments: benzodiazepine, antidepressant drugs or betablockers. |
| Verification of the MG status. | 5 seconds | Are you diagnosed with MG? (Yes/no/ maybe - still under examination) |
| Age | 5 seconds | How old are you? (unit: years) |
| Job | 5 seconds | How is your actually job status? (working fulltime/ working part time, student, retired, out of work, early retiree, sick leave). |
| Smoking | 5 seconds | Are you a smoker? (Never, ex-smoker, daily smoker, smoker but not every day, using e-cigarettes, using nicotine products) |
Countries
Denmark
Outcome results
None listed