Life-Style Exercise and Activity Package for People Living With Progressive MS (LEAP-MS)

Primary objectives. The primary objective is to establish the feasibility, acceptability and fidelity and safety of the LEAP-MS intervention for PwPMS and physiotherapists.

Secondary objectives. The secondary objectives are to validate the proposed intervention logic model through both qualitative assessment of intervention processes and descriptive evaluation of potential outcomes.

Study design and setting. This is a single arm feasibility study with an embedded process evaluation.

Study Intervention. The LEAP-MS intervention is a co-produced, digital interactive education and activity tool, specifically developed for PwPMS. The tool includes multimedia education about being active with PMS, tailored physical activity ideas and interactive functions enabling the development of personalised activity programmes, goal setting and activity logs. The digital tool works in conjunction with support from trained physiotherapists. The feasibility study will evaluate how the LEAP-MS intervention can be used in practice.

Patient participant study procedure. The investigators aim to recruit 21 PwPMS to participate in the LEAP-MS feasibility study. Patients will self refer to the LEAP-MS website.

Training physiotherapists. Physiotherapists will be trained on how to deliver self-management support to the participants. This training will have been developed following the information collected from physiotherapists and other health care professionals about their understanding of self-management and their needs for training about using self-management approaches with PwPMS.

Baseline Assessments.

The questionnaires will measure the impact MS has on functional abilities, including, a range of activities of daily living and quality of life:

1. Modified Fatigue Impact Scale (MFIS)
2. Multiple Sclerosis Impact Scale (MSIS-29)
3. EQ-5D-5L (EuroQol quality of life measure)
4. OX-PAQ (Oxford Participation and Activity Questionnaire)
5. University of Washington self-efficacy scale (UW-SES)
6. Participant Impression of Change (at 3 and 6 months only)

Follow-up. At 3 months post baseline, participants will again complete the above outcome measures, plus the Patients' Global Impression of Change online. Participants will also be telephoned to participate in an interview about their experiences of the intervention.

At 6 months post baseline participants will complete the same questionnaires as previously completed at baseline and 3 months.

Sample size. Twenty-one participants will be recruited to this feasibility study. The sample size is based on the width of a 95% confidence interval for a proportion and allows the proportion of eligible subjects recruited (70%) to be estimated to within +/-20%. The lower 95% confidence interval is 50% which is the minimum acceptable recruitment proportion.

Main analysis. The primary outcome will be based on the feasibility of the study in terms of quantitative measures recruitment, retention and intervention uptake. These proportions will be tabulated with 95% confidence intervals alongside the CONSORT chart which will detail the reasons for exclusion, refusal and dropout. For the clinical secondary outcomes, the data completeness for each measure will be tabulated. The distributions of the outcomes scores will be investigated and appropriate summary measures for the whole group tabulated with 95% confidence intervals at baseline and follow-up time points. An assessment of dropout bias will be made via tabulation of baseline measures for those with complete follow-up data and those who were not followed-up. No formal hypothesis tests will be carried out in the analysis.

Adherence data will be summarised using the following definitions

1. Study adherence: the proportion of participants returning completed outcomes measures
2. Intervention Uptake. Participants will be asked to use the LEAP-MS package during a 3-month period. This is a web-based package and as such participant 'logins' can be monitored. A pre-specified inactivity period of 2 weeks on the website by any one participant will automatically be logged and flagged to the corresponding patients' physiotherapist, who will then contact the participant to offer any further support.

Factors such as disease severity and self-efficacy that may plausibly impact on adherence and retention will be explored with graphical displays.

Progression criteria for a future evaluation will be defined through documentation of adherence and retention as benefits and challenges associated with adherence or lack thereof. We will also assess and record any adverse events that may be reported during participation in the feasibility study and in will consider excessive fatigue or pain that may be related to physical activity.

Qualitative data collection. Interviews with participants and physiotherapists Where consent is provided, interviews will be audio recorded and transcribed verbatim. References to identifiable personal details such as name, address, and date of birth, will be removed from the transcripts.

Observational data Observational data (i.e. proxemic sketches and kinesics data) will be collected on paper Case Report Forms (CRFs) and kept securely in locked files using participant identification (ID) numbers only.

Data from online interaction Data collected from online interaction (emails between patient and physiotherapist, goal setting and activity records) will be also be held on secure Centre for Trials Research (CTR) servers for analysis.

Quality Control and Assurance. The study risk assessment has been used to determine the intensity and focus of central and on-site monitoring activity in the LEAP-MS study. Low monitoring levels will be employed and are fully documented in the Study monitoring plan.