Table 1 .
Pre-specified progression criteria and observed results
| Feasibility outcome | Pre-specified progression criteria | Feasibility trial | |||
|---|---|---|---|---|---|
| Green | Amber | Red | Observations | Status | |
| Recruitment | |||||
| • Number of CHs recruited | 12 | 10 | <10 | 12 | Green |
| • Number of screened residents eligible and who consent to take part in the trial | ≥20% | ≥10% | <10% | 159 consented (53% of 300 screened) | Green |
| • Average number of residents in each CH recruited to the trial | ≥10 | ≥8 | <8 | 12.75 | Green |
| Intervention delivery Proportion of intervention CHs completing the series of three workshops and completing at least one observation review and one action plan review |
≥75% | ≥50% | <50% | 60% | Amber |
| Data collection and follow-up at 9 months | |||||
| • Proportion of residents providing usable accelerometer data | ≥75% | Not specified | Not specified | 65.6% | Amber/Red |
| • Proportion of residents having reported outcome measures from either themselves or a proxy | ≥75% | ≥65% | <65% | Staff informant/proxy: >75% Resident-reported: <55% |
Green Red |
| • Loss to follow-up at 9 months | ≤25% | ≤35% | <35% | 26.1% | Amber |
| Safety concerns in the view of the Programme Steering Committee | None | None | Major | None | Green |
Green = proceed to randomised controlled design; amber = review randomised controlled design and/or intervention delivery, then proceed; red = stop and do not proceed with current trial design and/or intervention and implementation).