Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis (LEAP-MS): adaptions during the COVID-19 pandemic and remote delivery for improved efficiency
Open accessAbstract
The LEAP-MS (Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis) study has developed an individualised supported self-management approach for physical activity for people with progressive multiple sclerosis (MS) and severe disability. The intervention has been evaluated in a single-arm feasibility study with embedded process evaluation. The feasibility study was due to open to recruitment during the COVID-19 2020–2021 pandemic, 1 month into the first UK-wide lockdown. We worked rapidly to implement adaptions to the trial procedures and intervention delivery that we believe are applicable to randomised controlled trials. Recruitment became predominantly via self-referral. Electronic consent was employed, with consent discussions occurring over the telephone. Registration, consent, eligibility assessment and data collection as well as the intervention (online physical activity tool) were via a secure, encrypted multi-user web-based platform for participants, physiotherapists and researchers accessible via various hardware. Physiotherapy consultations, as well as the process evaluation, were conducted remotely using video conferencing software or the telephone. A remote training package for physiotherapists and site initiations was also developed and electronic site files employed. Our adaptions are extremely topical given the COVID-19 situation, and whilst not what we had originally planned, have enabled successful delivery of the feasibility study and are relevant to conducting randomised controlled trials and meeting the needs of people with MS who are far more isolated than ever before. Trial registration: ClinicalTrials.gov NCT03951181 . Registered on 15 May 2019.
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The conduct of RCTs has changed with the increase in remote working, with study documentation such as the trial master file and investigator site files now often being electronic.
“The conduct of RCTs has changed with the increase in remote working, with study documentation such as the trial master file and investigator site files now often being electronic [82].”
From Blinding outcome assessors in randomised controlled trials of psychological interventions: how is it done? A narrative review (2026) · cites this paper as [82]
The Revised feasibility study protocol (Data collection and management) says LEAP-MS used electronic study master and investigator site files, and the Discussion confirms electronic trial master and site files. But LEAP-MS was a single-arm feasibility study; these passages do not establish that such files are now often electronic across RCTs. (LLM, conf=0.86)
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Self-citation
- Authors
- Lowe, R., Barlow, C., Lloyd, B., Latchem-Hastings, J., Poile, V., Scoble, C., Dean-Young, A., Button, K., Playle, R., & Busse, M.
- Affiliations
- Cardiff University (GB)
- Corresponding author
- Busse, Monica
- ORCID
- Venue
- Trials
- Published
- 2021-04-16
- Volume
- 22
- Issue
- 1
- Pages
- 286-286
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC8050990
- OpenAlex
- W3155833508
- Cited by
- 19
- References
- 32
- Citations by year
- 2026: 1 · 2024: 1 · 2023: 2 · 2022: 10 · 2021: 5
- FWCI
- 3.00
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ORCA Online Research @Cardiff (Cardiff University) (acceptedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Research Portal (King's College London) (submittedVersion, other-oa)
- Funders
- Multiple Sclerosis Society (81)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Health Sciences › Medicine › Physiology › Physical Activity and Health
- Keywords
- progressive multiple sclerosis, self-management support, physical activity, exercise intervention, remote intervention delivery, COVID-19 pandemic, feasibility study, physiotherapy, web platform, electronic consent, severe disabilities
- MeSH terms
- COVID-19, Humans, Life Style, Multiple Sclerosis, Research Design, Self Care, Exercise, Telemedicine, Patient Selection, Disease Management, Videoconferencing, Pandemics
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