Table 4

Internal pilot to main trial progression rules

CriteriaScenario 3Scenario 2Scenario 1
% of internal pilot sample size target (180 patients) recruited<65%65%–79%≥80%
Intervention engagement
(% participants who access e-coachER at least once)
Proposed actionNo progressionDiscuss with Trial Steering Committee and funder about progression and resources needed to achieve target.Proceed to full trial.