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LEAP-MS: Adaptions for Advanced Stages
Lifestyle, Exercise and Activity Package for People Living with Progressive Multiple Sclerosis (LEAP-MS): adaptations for remote delivery & improved efficiency
Multiple sclerosis (MS) is the most common neurologic disorder of young and middle-aged adults. MS expresses itself in four clinical forms: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), primary progressive MS (PPMS), and progressive relapsing MD (PRMS). The course of the disease is highly varied and unpredictable. In most patients, it is characterized initially by episodes of reversible symptoms, which is often followed by progressive neurological deterioration over time.
Based on the MS prevalence data released by Public Health England in 2020, the prevalence of MS in England is 190/100,000 people. Currently, 4,950 new cases of MS are diagnosed each year in England. Approximately 2.8 million people worldwide, including 130,000 in the U.K, are affected by the disease.
Background to LEAP-MS
MS patients were advised for many years not to exercise because it was thought to aggravate pain or make their fatigue worse. However, Sutherland et al., S Mostert et al., Fabio et al., and Erin et al independently reported that the MS exercise group had improved quality of life, well-being, walking ability, and less fatigue compared to the MS non-exercise group. Micheo et al. reported that inactivity among MS patients makes the joints inflexible as the connective tissues become shorter. Given this background, several authors assessed the association of physical activity with the risk of MS. The studies have shown that exercise can benefit the long-term management of MS. Regular, moderate physical exercise can improve fitness and endurance, maintain patients’ range of motion, and ease symptoms related to spasticity.
Various physical activity interventions for patients with MS have been reported in the literature. Group-based to digital versatile disc (DVD) and web-based interventions, for example. However, many of the studies were based on structured exercise rather than personalized approaches. Furthermore, as with most MS interventions to date, studies have exclusively focused on ambulatory patients, despite non-ambulatory patients, with more advanced disability being most at risk of becoming sedentary.
Despite the numerous literary works that strongly recommend tailored physiotherapy for patients with MS, there remains little evidence about the benefits of tailored programs for PwPMS who tend to be more disabled than those with RRMS or SPMS.
The ‘Lifestyle Exercise and Activity Package for Multiple Sclerosis’ (LEAP-MS), aims at providing a sustainable, personalized physical activity intervention for people with progressive MS. LEAP-MS also lets PwPMS self-manage physical activity both in and out of their homes.
Phase 1: Qualitative interview
The authors used semi-structured interviews and collected information about (1) the experiences of patients with progressive MS (PwPMS) and their families/carers in accessing and overcoming barriers while doing physical activity and (2) the understanding, experiences, and training needs of physiotherapists in delivering self-management support to PwPMS.
Phase 2: Intervention development and feasibility testing
Phase 1 data was used to co-design a personalized LEAP-MS program comprising,
- A multi-user web-based online physical activity tool
- Up to 6 physiotherapy consultations
- A training package for physiotherapists about self-management with PwPMS
A single-arm feasibility study with an embedded process evaluation was used to evaluate the intervention. The feasibility study was due to open to recruitment during the 1 month into the first UK-wide lockdown.
The original feasibility study protocol
The Ethical approval was granted by Wales Research Ethics Committee 6 (reference: 19/WA/0195).
Sample size. 21 participants with either primary or secondary progressive multiple sclerosis. All participants were aged 18 or above and had an Expanded Disability Status Scale (EDSS) score between 6 and 8. This study excluded patients with relapse-remitting or non-progressive MS; patients unable to understand written and spoken English, or are pregnant or planning a pregnancy were also excluded.
Recruitment. The 3 recruitment routes were: (1) an MS research database hosted in the NHS, (2) referral from NHS outpatient physiotherapy services, and (3) self-referral from within the Health Board. All potential participants submitted an expression of interest form and completed an eligibility checklist via the LEAP-MS site.
Eligibility screening and informed consent. The eligibility of participants was reconfirmed at the home-based coaching session with the physiotherapist. Online consent was collected from the interested participants and was directed to complete the baseline assessment.
Assessments. All 21 participants completed baseline self-report measures after which the intervention was assessed for an initial 3-month period.
- Modified form of the Fatigue Impact Scale (MFIS) – to assess how fatigue affects physical, cognitive, and psychosocial functioning
- Multiple Sclerosis Impact Scale (MSIS-29) – to measure the physical and psychological impact of MS on a patient’s day-to-day life.
- EuroQol quality of life measure (EQ-5D-5 L) – to measure the quality of life including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
- Oxford Participation and Activities Questionnaire (OxPAQ) – to assess the impact of ill-health on patients’ routine, emotional wellbeing, and social engagement.
- University of Washington 6-item short form self-efficacy scale (UW-SES-SF) (MS-specific) – to measure self-efficacy
- Modified Patients’ Global Impression of Change (PGIC) – at 3 months and 9 months follow-up only.
During the initial 3-month period, participants were also given the option to request up to five further home-based or online physiotherapy coaching sessions. Follow-up questionnaires and semi-structured interviews were again administered after 3 months. Use of the LEAP-MS platform was tracked during the full 6-month period and final follow-up was conducted 6 months after baseline. Feasibility outcomes (recruitment, retention, intervention fidelity, website usage statistics, and safety) were reported and the process evaluation explored participant experiences of the intervention and all possible mechanisms for any observed effects.
Restrictions and Implications
The spread of illness has complicated self-management interventions for PwPMS, requiring revisions in the feasibility study protocol. The important amendments include,
Setting up non-NHS research sites because of staff redeployment and revised NHS priorities; physiotherapists for the intervention were selected from within the project team.
Intervention training. The initial LEAP-MS training package for the 10 participating physiotherapists was developed through a two-day face-to-face workshop by Bridges Social Enterprise, UK. It focused on self-management support to PwPMS, technology-assisted consultations, physical intervention guidelines, and potential challenges & solutions in using the LEAP-MS platform. Resources for remote interaction were optimized and made available to the staff. Site initiation training was via Zoom. Recorded videos, user guides, and conversation-based scripts were also made available via the LEAP-MS multimedia online learning resource.
Recruitment, e-consent, and eligibility assessment. Physiotherapists who attended the training and site initiation were asked to complete an informed consent form using Cardiff’s online survey software. A local copy of the consent was saved and emailed to the LEAP-MS email address. Another copy was saved in the electronic investigator site file. MS Society endorsed communication channels served as an additional recruitment pathway. Potential participants within the South Wales region were emailed by the MS register; the MS research database was also used to send letters to the participants. A patient information sheet accompanied the email and letter. Potential participants were given a unique login to the online study platform to share contact details and fill in eligibility forms. An automated email was sent to the LEAP-MS email account to notify the staff of the registration. Each participant was then contacted by the central study team to review the initial eligibility screening. Post reconfirming eligibility, and e-consent was released to the LEAP-MS account of potential participants and were asked to complete an online consent form and the baseline measures.
Intervention delivery. Participants were offered virtual physiotherapy consultations using Zoom or telephone. A practice Zoom session was given to all participants before the first physiotherapy session. All risk assessment documentation was revised to address virtual intervention delivery.
Data collection and management. The follow-up period of baseline assessment was reduced from 9 months to 6 months. The investigators developed an encrypted multi-user web-based platform for participants, physiotherapists, and researchers; it is accessible via desktop, laptops, tablets, or smartphones. The LEAP-MS platform was used to register, complete eligibility forms, consent, baseline, and follow-up measures as well as the intervention. As participants entered their own data; to limit errors and ensure quality, input masks, restricted data formats, and mandatory data fields were used. The study team also used the platform to manage the data and to evaluate participant engagement. The process evaluation was also done remotely.
The LEAP-MS platform is a unique multi-user system that enables participants and physiotherapists to co-create tailored physical activity self-management interventions. Given the challenges in rehabilitation service delivery during lock downs, LEAP-MS stands as an effective means to successfully recruit, consent, deliver and evaluate physical activity intervention in people with progressive MS who were increasingly isolated.
Advertising LEAP-MS study to potential participants via MS Society communication channels proved highly efficient. The researchers received greater reach as expressions of interest became independent of the Health Board. Though the central study team failed to ensure clinical confirmation of the EDSS score, it was overcome by introducing an additional eligibility screen.
The electronic registration and consent process eliminated the need for a separate study visit to obtain informed consent from the participants. It was found that 1/3rd of the participants required explicit instructions and a link to the LEAP-MS site before they were able to access the site and fill the online consent form. This may be due to the impaired cognitive and memory function, the common symptoms of MS. The study team suggested integrating an automated email function into the LEAP-MS platform to notify the patients of the release of the consent form. Zoom was the software of choice for video consultation. Technical issues related to internet connectivity, sound or video quality, and user capability were reported. 2 participants, in fact, had their 1st consultation over the phone; one of these patients used the telephone for his second consultation.
In the revised LEAP-MS intervention, the waiting time for initial physiotherapy was only 3 weeks compared to the home visit waiting times of up to 8 weeks. This was partly due to the study using both NHS and non-NHS staff. Also, there was no need for a physiotherapist to visit a patient’s home to obtain an informed consent or to do initial eligibility screening.
Every MS patient can benefit from interventions that are tailored to her or his needs, abilities, and preferences. Designed as a future-proof intervention, LEAP-MS helps to reduce PwPMS’s reliance on health professionals and to increase their sense of autonomy, and to establish control over health and well-being. Given the pandemic situation and social isolation, this novel approach is relevant for MS patients with high levels of disability and impairment. Future randomized evaluation is needed to measure the intervention’s acceptability.
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