Table 2 Proposed protocol changes in response to COVID-19

Recruitment

Study information will be shared via email, where possible, or post.

Screening visit will be completed via telephone.

Consent form will be completed and returned by post or email, where possible.

Participants can identify a carer to support them. Carer consent will be obtained.

Rolling recruitment will take place as there will be no group component to the intervention and to reduce clinician burden when delivering the intervention.

Randomisation

Participants will be randomised at individual level (due to practicalities of rolling recruitment, e.g. to ensure allocation concealment as participants from the same residential setting may enrol at different times) to either intervention or control group in a 2:1 ratio after completion of the baseline assessment. The allocation ratio was changed to ensure sufficient number of participants are exposed to the intervention and optimal information on intervention delivery can be collected, given that there may be recruitment challenges with remote recruitment and delivery. With 2:1 allocation ratio, two-thirds of participants enrolled will be randomised to the intervention group. Allocations will be undertaken using a permuted block design with unequal block sizes (of 3, 6, 9). A researcher independent of the study will generate the randomisation sequence and allocate the participant after baseline data collection. The randomisation sequence will be concealed from members of the research team involved in participant management to prevent biased allocation [47, 48].

Intervention delivery

Education session (both intervention and control groups) will be delivered remotely via telephone or video conference depending on technology accessible to the individual.

Study materials will be posted to participants.

Instructions will be sent via email or post and the researcher will provide additional instruction via telephone or video call.

Fortnightly coaching calls will be delivered remotely by telephone or video call.

Delivery of the weekly group walk will depend on current guidance regarding physical distancing.

Outcome assessment

Participants will be given the option to complete questionnaires via email, post, telephone or video call. This will include using alternative versions of tools that are suitable for remote delivery, where required i.e. using the Blind-MoCA, which omits requirement of pencil and paper or visual stimulus, and is suitable for telephone administration of the test [49].

Accelerometers will be posted to participants with instructions and the researcher will provide additional instruction via telephone or video call.

Anthropometric measures will be collected from patient files, where available.

Exploration of remote methods of collecting data related to functional mobility, i.e. replacing the Timed-Up-and-Go test with a remote Sit-to-Stand test [50].

Interviews with participants, clinicians and carers will be carried out by telephone or video call.