REMOTE v1.0
Research type
Research Study
Full title
Remote Evaluation of Multiple sclerosis Outcomes Through Engagement: a feasibility study
IRAS ID
353765
Contact name
Emma Tallantyre
Contact email
Sponsor organisation
Cardiff University Research Integrity, Governance and Ethics Team
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Multiple sclerosis (MS) is a chronic condition. Symptoms can fluctuate over time or there may be progression of symptoms over many years. Long-term follow-up of clinical trial participants with MS is valuable to assess the full impact of interventions. However, there are barriers to some people with MS taking part in clinical trials, especially those with long periods of follow-up. These barriers include distance and/or lack of transport to reach clinical sites, advanced disability of participants, burdensome symptoms, inflexible working hours, or the need for childcare.
One idea to increase MS trial participation and long-term follow-up is for participants to do their own assessments at home ('remote' clinical assessment). Remote assessments may offer several advantages: 1) Completing assessments at home would overcome inclusion barriers such as access to trial centres, 2) Assessments performed remotely may better reflect participants’ real-life performance status, 3) Remote assessments may offer greater cost-efficiency. However, fully remote assessments pose risks, including poor quality or missing data.
We are undertaking this study to investigate i) the feasibility of remotely collecting clinical assessment data and ii) the validity of remote data compared with that from in-person assessments. We will utilise an existing clinical trial population who are attending in-person visits, and ask them to complete remote assessments in parallel (self-report of disability (web Expanded Disability Status Scale), Timed 25-foot walk, 9-hole peg test, Symbol Digit Modalities Test). In a sub-set of participants we will investigate the feasibility of using ultra-low-field MRI to monitor MRI-derived biomarkers of disease (e.g. number of lesions and brain volume). Ultra-low-field MRI scanners are designed to be portable, opening up the possibility of remote MRI.
Results will inform and help to develop a framework for the use of remote assessments in MS clinical trials.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
25/WM/0158
Date of REC Opinion
27 Aug 2025
REC opinion
Further Information Favourable Opinion