1. Trial Set-up Phase
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– Equipment provision |
□ How many full sets of equipment will be required, considering; |
→ What is the provisional budget for equipment? |
→ How many participants can concurrently undertake the intervention? |
□ What spare equipment is required in case of breakages? |
→ e.g. monitors |
□ Are additional items such as extension leads, surge protection, batteries, tape to secure leads, sanitising wipes, etc. required? |
□ Has electrical or safety testing been carried out on the electrical equipment? |
□ Has the equipment been security marked in case of theft – e.g. with Smartwater? |
– Researcher/Therapist Training |
□ What level of training will be required to deliver the intervention? |
□ Who will deliver and monitor the training? |
□ Will training also be required for assessments? |
– Transportation |
□ Are protective bags and/or boxes required to transport the equipment? |
□ Will help be needed to load/unload equipment – e.g. trolleys, parking provision? |
– Insurance |
□ Do those transporting the equipment need business use on their car insurance? |
□ Is the equipment insured for breakages or theft, during transport or while in the participant’s home? |
□ Does insurance cover damage to the participant’s home? |
2. Screening
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In addition to study inclusion and exclusion criteria, the following factors may also need to be considered to determine participant suitability: |
– Does the participant have the required resources at home? e.g.: |
□ Are there tables, chairs, TV/monitor of appropriate size and height? Is there high-speed internet connection? |
□ Is there sufficient free space to undertake the intervention activities? |
□ What resources can be provided by the research team if required? |
→ e.g. suitable chairs, chair risers, monitor risers, portable tables |
□ Is there suitable access to the participant’s property? |
→ e.g. parking, distance from parking to the home, stairs, lifts etc. |
3. Equipment Set-up & Storage
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Ensure equipment is left safe and secure and that the participant is consulted during the set-up process: |
□ Have potential safety concerns been discussed with participant? |
→ e.g. trip hazards, overuse |
□ Have any electrical leads been secured so that they are not trailing? |
□ Has appropriate equipment storage been discussed with the participant? |
→ e.g. will they need to pack the equipment away when not in use, and will they be able to manage this unaided? |
□ Is it appropriate for participants to sign documentation to confirm what equipment has been supplied? |
4. Participant Training & Monitoring
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– Participant support |
□ Will accessible written instructions be helpful? |
→ e.g. FAQ, what to do if problems occur |
□ Is there a specific phone line that participants can call for help? |
→ how will this be managed and by whom – e.g. five days a week, in usual work hours? |
□ How should the researchers respond when issues are reported? |
→ what additional technical support can be provided? |
→ can spare equipment be provided in the event of faults or breakages? |
→ what are the acceptable timeframes within which to respond to an issue? |
→ how will researcher availability affect this? What is the potential impact of staff annual leave? |
– Monitoring and data collection |
□ Should field notes be taken on each participant visit? |
→ e.g. to record any individual equipment set-up, visit duration, observed issues and how they were addressed |
□ What is an acceptable schedule to monitor participant progress? |
→ e.g. weekly or fortnightly phone calls and/or visits |
□ Will any data recorded by the VR system need to be manually collected at specific intervals? |
□ How will participant adherence be monitored? |
→ e.g. will the participant need to self-report adherence or can this be recorded by the VR system? |
□ How will participants be cued to recommended session durations with the intervention? |
→ e.g. will the participant need to monitor time or can the VR system provide time prompts? |