Feasibility Trial Design

The recruitment target was set at 60 participants — a base sample of 50 inflated by 20% to account for anticipated dropouts, consistent with precedents from other CKD feasibility trials. As a feasibility trial with a small sample over a short duration, the study is not designed or powered to detect intervention effectiveness. Outcome assessors are blinded to group assignments to mitigate detection bias, though participant and researcher blinding is not possible. All analyses follow an intention-to-treat approach, with no imputation of missing data from dropouts. The SAM-CKD trial is designed and reported according to the CONSORT statement extension for randomised pilot and feasibility trials. A 2:1 unequal allocation ratio is used so the lead investigator can gain experience delivering the newly developed programme. App usability and acceptability are assessed at week 6 using the 18-item Vietnamese MAUQ, which has three subscales and uses a 7-point Likert scale. If feasibility thresholds are met, findings will inform the design of a fully powered effectiveness trial.