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 |