Table 1 Santé-AF feasibility objectives and thresholds (progression criteria)
Objective | Measurement | Feasibility threshold (progression criterion) | Data collection point | n included in analysis | |
|---|---|---|---|---|---|
Objective 1: Participants’ willingness to take part | Percentage of eligible participants randomised | ≥90% | Baseline | 29 | |
Objective 2: Appropriateness of eligibility criteria | Percentage of identified participants eligible | ≥60% | Pre-consent | 220 | |
Objective 3: Participant retention | Percentage of participants retained at follow-up | ≥80% | Follow-up | 25 | |
Objective 4: Intervention acceptability | a. Participant satisfaction with group allocation @ 7–10 on 10-point scale | ≥75% | Post-baseline | 29 | |
b. Participant report of intervention acceptability @ 1–3 on 7-point scale | ≥75% | Follow-up | 20 | ||
Objective 5: Acceptability of study assessments | a. Completeness of main outcomes data | ≥80% | Baseline; follow-up | 30 | |
b. Participant report of intervention acceptability @ 1–3 on 7-point scale | ≥90% | Follow-up | 25 | ||
Objective 6: Utility of CardioSTAT® monitor | a. Participant report of monitor influence on participation @ 1–2 on 5-point scale | ≥50% | Baseline; follow-up | (abandoned as unviable) | |
b. Difference in number of AF episodes recorded by monitor and symptom diary | ≤1 episode difference | Follow-up | (abandoned as unviable) | ||
Objective 7: Experience of study participation | Participant report of overall study acceptability @ 1–2 on 5-point scale | ≥75% | Follow-up | 25 | |