Table 1.
Feasibility component | Outcome measure | Criterion for success | Study results |
---|---|---|---|
Process | |||
Recruitment rate | Number of Part. recruited | 2 part./month/site | 1.9 part./month/site |
Consent rate | % part. consenting | > 65% of part | 93% |
Retention rate | % part. completing study | > 85% complete T1 | 93% |
Perceived satisfaction | 7-pt Likert scale | > 85% report perceived benefits | 100% |
Resources | |||
Adherence rate | Attend ≥ 10/12 intervention sessions | > 85% of subjects | 100% attended 12 sessions |
Session length | Evaluations < 2 h | > 85% of evaluations | 100% |
Intervention burden | Interventions < 1.15 h | > 85% of sessions | 89.3% |
Management | |||
Participant processing time | Time initial contact to enrolment | Mean time < 10 days | 100% |
Treatment | |||
Safety (evaluation) | Adverse events | No adverse event | No adverse event |
Safety (intervention) | Adverse events | No adverse event | No adverse event |
Part.: Participants