Key indicator | Proceed | Amend | Stop |
---|---|---|---|
Recruitment rate Target figure: 30 participants | ≥ 70% of target number | 51–69 % of target number | ≤ 50% of target number |
Retention rate Target figure: 75% of participants randomised to intervention group will complete outcome measures at T1, T2, and T3 [36] | ≥ 70% of target number | 51–69% of target number | ≤ 50% of target number |
Acceptability | Intervention is described as acceptable by participants in its current form | Intervention is described as acceptable with recommended changes to improve participant experience | Intervention is described as unacceptable by participants |
Action | Continue with intervention and study design with collaboration between research team, clinical collaborators, and PPI contributors | Consultation with research team, clinical collaborators, and PPI contributors regarding necessary amendments to the intervention and study design | No progression to further trial |