Table 1 Schedule of Events for the COPE trial
Schedule of events | Baseline visit 2–12 weeks post-fracture (14–84 days) | CBT sessions (if applicable) (6–12 weeks post-fracture) | 3-month follow-up 2–4.5 months post-fracture(85–137 days) | 6-month follow-up 4.5–7.5 months post-fracture(138–228 days) | 9-month follow-up 7.5–11 months post-fracture (229–336 days) | 12-month follow-up 11–15 months post-fracture (337–456 days) |
|---|---|---|---|---|---|---|
Assess eligibility | X | |||||
Informed consent | X | |||||
SPOC questionnaire | X | |||||
Randomization | X | |||||
Weightbearing and activity level form | X | |||||
Demographic and baseline data | X | |||||
CBT intervention | X | |||||
Follow-up form | X | X | X | X | ||
Persistent post-surgical pain assessment | X | X | X | X | ||
BPI-SF Questionnaire | X | X | X | X | X | |
Return to Function Questionnaire | X | X | X | X | X | |
SF-36 Questionnaire | X | X | X | X | X | |
Fracture-related complications assessment | X | X | X | X | X | |
SAE assessment | X | X | X | X |