The United Kingdom Multiple Sclerosis Register Covid-19 Substudy

Study Overview
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Brief Summary
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The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.

Detailed Description
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Study objectives To identify the incidence of upper respiratory tract symptoms: fever, cough and breathing difficulties, other symptoms suggestive of COVID-19 infection, respiratory tract infections suggestive of COVID-19, and COVID-19 confirmed by laboratory testing among the UK MS population To establish if some DMDs increase the risk of COVID-19 infection To determine the incidence and effectiveness of self-isolation in the MS population. To examine the impact self-isolation has on mood, fatigue, and other routinely collected patient reported outcome measures from the MS Register. To determine the clinical outcome of respiratory tract infections, including confirmed and suspected cases of COVID-19, in terms of symptoms, time to recovery, hospital admission, requirement for ventilation, and death. To determine the longer-term impact of COVID-19 on MS, using routinely collected MS outcomes in the MS register, including impact on disability, relapses and changes in DMDs as assessed at 3 monthly intervals. To determine where people are obtaining their health information during the COVID-19 outbreak. To establish changes in DMDs prior to and as a result of symptoms related and unrelated to COVID-19

Official Title
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The UK MS Regsiter COVID-19 Substudy

Conditions
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Multiple Sclerosis, COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 and confirmed diagnosis of MS, enrolled on UK MS Register Exclusion Criteria: None of the above

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Confirmed Cases<br>Diagnosed by health professional / Covid-19 test Monitored through fortnightly questionnaires | |
| Not Covid-19 cases<br>Through self report no suspicion of COVID-19, tested by fortnightly questionnaire. non Covid Cases can become COVID cases through self report. | |
| Suspected Covid-19 Cases<br>Participants that are suspected of having Covid-19 but this has not been confirmed by health professional or Covid-19 test has not been performed. Fortnighly questionnaire | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 Infections within an MS Cohort in the UK | Targeted questionnaire dependent on COVID Status | Through study completion, an average of 1 year | 
| Hospitalisations in MS Patients with COVID-19 | Monitor admission rates in linked population | 1 Year (regular outputs) | 
| Mortality | Death data from routinely reported government level data (HES/PEDW) | 1 Year from study commencement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Expanded Disability Status Score | Patient Reported Outcome for MS disability | 1 year (at least 6 monthly) | 
| Hospital Anxiety and Depression Scale | Patient Reported Outcome for anxiety and depression | 1 year (at least 6 monthly) | 
| Multiple Sclerosis Impact Scale 29 V2 | Patient Reported Outcome for Multiple sclerosis impact on physical and psychological status | 1 year (at least 6 monthly) | 
| Multiple Sclerosis Walking Scale 12 V2 | Patient Reported Outcome for walking status | 1 year (at least 6 monthly) | 
| Fatigue Severity Scale | Patient Reported Outcome for impact of fatigue | 1 year (at least 6 monthly) | 
| EuroQol 5D (3l) | Patient Reported Outcome for general quality of life | 1 year (at least 6 monthly) |