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

Rachel Lowe,Julie Latchem-Hastings,Kate Button,Charlotte Scoble,Monica Busse,Christy Barlow,Vincent Poile,Barry Lloyd,Andrew Dean-Young,Rebecca Playle

doi:10.1186/s13063-021-05245-1

Rachel Lowe, Julie Latchem-Hastings + Show 8 more

Open Access

https://doi.org/10.1186/s13063-021-05245-1

Copy DOI

Journal: Trials	Publication Date: Apr 16, 2021
Citations: 15	License type: open-access

Affiliation: Cardiff University

Abstract

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.

Highlights

Background to LEAP-Multiple sclerosis (MS) LEAP-MS (Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis) aims to develop and evaluate an individualised supported self-management approach for physical activity with a specific focus on people with progressive multiple sclerosis (PwPMS) and severe disability
Of these it is estimated that 10–15,000 have primary progressive MS [2] and 38,000 secondary progressive MS [3], which are characterised by worsening of symptoms either independent of relapses/remissions or with relapses
Various interventions are reported in the literature, ranging from group interventions to digital versatile disk (DVD) and web-based interventions [10,11,12,13,14] but most research to date has focussed on patients who are walking and evidence in progressive MS is inconclusive [8, 15, 16]

Summary

Introduction

Multiple sclerosis (MS) is a long-term deteriorating condition which causes a range of symptoms like blurred vision and problems with how people move, think and feel affecting an estimated 107,000 people in the UK [1]. Of these it is estimated that 10–15,000 have primary progressive MS [2] and 38,000 secondary progressive MS [3], which are characterised by worsening of symptoms either independent of relapses/remissions or with relapses. Various interventions are reported in the literature, ranging from group interventions to digital versatile disk (DVD) and web-based interventions [10,11,12,13,14] but most research to date has focussed on patients who are walking and evidence in progressive MS is inconclusive [8, 15, 16]

Objectives

Conclusion