Pilot Cluster Randomised Controlled Trial

Findings suggest a future definitive trial may be better designed with individual rather than cluster randomisation. The pilot will not conduct a definitive economic evaluation. Cluster randomisation was chosen to reduce contamination, because therapists delivering MAINTAIN might also provide routine care. Hospitals rather than individuals were randomised to reduce contamination between trial arms. Therapists and participants could not be blinded to allocation because of the nature of the intervention. Randomising clusters before enrolment created risks of baseline imbalance and selection bias. The pilot's primary objective was feasibility, not clinical effectiveness. The trial was conducted across six UK sites representing primary care, secondary care, NHS mental health, community rehabilitation, and one charitably funded dementia service. The pilot aimed to determine whether a full-scale cluster RCT comparing ATLS, PTC, and standard care could be feasible in India. Phase 2 tests feasibility, acceptability, usability, cybersickness measures, culture measures, resident outcome data collection and implementation methods for a later full RCT.