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

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 registration ClinicalTrials.govNCT03951181. Registered on 15 May 2019.

Conducting a randomised controlled trial of a psychosocial intervention for adolescents with type 1 diabetes during COVID-19: recommendations to overcome the challenges complicated by inconsistent public health guidelines on research

“…Thus, administering the RCT also involved a lot of direct face-to-face contact and communication with patients. Interestingly, some RCTs testing out psychosocial interventions did not experience similar challenges because they were able to recruit virtual patients, whereas we were not allowed to do so [ 12 , 13 ].…”

“…Sharing expertise and learning from other research studies who are in a similar situation is important [ 6 ], especially where there is little or varying public health guidelines on continuing research during a pandemic [ 1 ]. Although there are numerous papers reporting on managing clinical trials during the COVID-19 pandemic, there is very little addressing the challenges of conducting an RCT of a psychosocial intervention, which requires direct patient contact in a hospital setting [ 12 , 13 ].…”

The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience

“…The challenges faced by CogEx are to varying degrees shared by other clinical trials that have been active during the pandemic [8,9], although the nature and frequency of our interventions (24 face-to-face supervised treatment sessions in 12 weeks with pre and post assessments within this window along with longer-term follow-up) speaks to the particular intensity of our methodology. To date, the generic challenges faced by clinical trial lists during the pandemic have been addressed by the Food and Drug Administration (FDA) [10] and the Centers for Disease Control and Prevention (CDC) [11].…”

Lifestyle, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS): protocol for a single-arm feasibility study

“…Coaching sessions will be conducted at participant’s homes or online dependent on participant preference whilst accommodating any local restrictions (e.g. social distancing during COVID-19 or staff availability—see [ 62 ] for COVID-19 study adaptations). When conducted online, coaching sessions will be conducted via a secure web video conferencing system.…”