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

Trials

Vincent Poile¹  Charlotte Scoble¹  Monica Busse¹  Julie Latchem-Hastings¹  Andrew Dean-Young¹  Barry Lloyd¹  Rebecca Playle¹  Rachel Lowe¹  Christy Barlow¹  Kate Button² 

[1] Centre for Trials Research, Cardiff University, 4th floor Neuadd Meirionnydd, Heath Park, Cardiff, UK;School of Healthcare Sciences, Cardiff University, Ty Dewi Sant, Heath Park, Cardiff, UK;

关键词: COVID-19 adaptions;    Trial management;    Recruitment;    Electronic consent;    Feasibility study;    Remote intervention delivery;    Multiple sclerosis;    Physiotherapy;    Physical activity;    Self-management;   

DOI  :  10.1186/s13063-021-05245-1

来源: Springer

【 摘 要 】

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 registrationClinicalTrials.govNCT03951181. Registered on 15 May 2019.

【 授权许可】

CC BY