VRMG: Vitaccess Real MG Registry
Study Details
Study Description
Brief Summary
Vitaccess Real MG is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records.
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Detailed Description
Adult patients who are being treated for MG at one of the participating clinics or centers in one of the study countries (the US, UK, Germany, France, or Italy) at the time of enrolment and who meet the inclusion and exclusion criteria will be identified and approached by their clinical team and invited to participate in the registry.
Patient-reported data will be collected via the Vitaccess RealTM MG Registry platform, a digital data capture platform accessible via smartphone or tablet (from the Apple or Android app store) or via PC. Custom survey and patient-reported outcomes data will be collected at baseline and at regular intervals thereafter for a follow-up period of up to 10 years. The data collected will capture the impact of MG on daily living, fatigue, and health-related quality of life.
Site research teams will complete and update an eCRF (every six months ± one months) for each patient, including data from the patient's EMR. eCRFs that are completed within one months prior to or following each six-month mark will be considered within the same assessment window for analytics purposes so that patients will not be required to visit the clinical site for the purposes of the registry outside of their regular clinical visits.
Patient- and HCP-reported data will be linked via a unique ID and PIN assigned to each participant at enrolment.
Study Design
Outcome Measures
Primary Outcome Measures
- The Vitaccess Real MG Registry [10 years]
A patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life.
Secondary Outcome Measures
- Describe the demographic characteristics of patients [At baseline]
EMR data reported by HCPs via eCRF ("Demographic Information Form")
- Describe change in clinical trial participation of patients [At follow-up visits (every 6±1 months) for up to 10 years]
EMR data reported by HCPs via eCRF ("Clinical Trial Participation Form")
- Describe the diagnosis (date, tests, and symptoms) of patients [At baseline]
EMR data reported by HCPs via eCRF ("Diagnosis Information Form")
- Describe change in clinical characteristics of patients. [At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
EMR data reported by HCPs via eCRF ("Clinical Characteristics Form")
- Describe change in medical history of patients [At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
EMR data reported by HCPs via eCRF ("Medical History Form")
- Describe change in concomitant treatments received by patients [At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
EMR data reported by HCPs via eCRF ("Concomitant Medication Log")
- Describe change in routine MG treatments received by patients [At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
EMR data reported by HCPs via eCRF ("Routine MG Treatments Log")
- Describe change in rescue MG treatments received by patients [At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
EMR data reported by HCPs via eCRF ("Rescue MG Treatments Log")
- Describe change in severity of MG symptoms experienced by patients [At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by HCPs via eCRF ("MG-ADL")
- Describe change in healthcare resource use of patients [At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
EMR data reported by HCPs via eCRF ("Healthcare Resource Use")
- Describe change in type and severity of adverse events experienced by patients [At follow-up visits (every 6±1 months) for up to 10 years]
EMR data reported by HCPs via eCRF ("Adverse Events")
- Describe change in severity of MG symptoms experienced by patients [At baseline and every 1 month thereafter for up to 10 years.]
Myasthenia Gravis Activities of Daily Living (MG-ADL) data reported by patients via the Vitaccess Real MG Registry platform ("MG-ADL")
- Describe change in type and severity of fatigue experienced by patients [At baseline and every 2 months thereafter for up to 10 years.]
MG Symptoms PRO Fatigue Component data reported by patients via the Vitaccess Real MG Registry platform ("MG Symptoms PRO Fatigue Component")
- Describe change in type and severity of fatigue experienced by patients [At baseline and every 2 months thereafter for up to 10 years.]
NeuroQoL Fatigue Short Form data reported by patients via the Vitaccess Real MG Registry platform ("NeuroQoL Fatigue Short Form")
- Describe change in impact of MG on health-related quality of life of patients [At baseline and every 2 months thereafter for up to 10 years.]
Myasthenia Gravis Quality of Life 15-item revised scale (MG-QoL-15r) data reported by patients via the Vitaccess Real MG Registry platform ("MG-QoL-15r")
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult (age ≥18 years) with a clinically-confirmed diagnosis of myasthenia gravis (MG).
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Resident in the US, UK, Germany, France, or Italy.
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Access to a smartphone/tablet/computer/laptop
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Willing and able to provide informed consent in their local language to take part in the study.
Exclusion Criteria:
- Participation in a clinical trial at the time of study enrolment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vitaccess Ltd | Oxford | Oxfordshire | United Kingdom | OX4 4GA |
Sponsors and Collaborators
- Vitaccess Ltd
Investigators
- Principal Investigator: Mark JW Larkin, PhD, Vitaccess Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5137-Vitaccess-MG-01