Baseline (clinic) | 6 weeks (clinic) | 12 weeks (clinic) | 26 weeks (clinic) | 52 weeks (remote) | |
---|---|---|---|---|---|
Baseline and other covariates | |||||
Pre-screening form/log (before baseline visit) | X | - | - | - | - |
Eligibility form | X | - | - | - | - |
Surgery details form | X | - | - | - | - |
Informed consent form | X | - | - | - | - |
Contact details | X | - | - | - | - |
Demographics | X | - | - | - | - |
Employment (including sick pay provision) | X | X | X | X | X |
Vehicle use | X | - | - | - | - |
Randomisation (at baseline) | X | - | - | - | - |
Primary outcome | |||||
Patient-Rated Wrist and Hand Evaluation (PRWHE) | X | X | X | X | X |
Patient-reported measures | |||||
Patient Evaluation Measure (PEM) | X | X | X | X | X |
Work productivity and activity impairment (WPAI) | X | X | X | X | X |
EuroQoL EQ-5D-5L | X | X | X | X | X |
Litigation/compensation | - | - | - | - | X |
Global rating of change (GRoC) | - | X | X | X | X |
Preferences for splint attributes | X | X | - | - | - |
Clinical outcomes | |||||
Range of movement | X | X | X | X | - |
Grip strength | - | - | X | X | - |
Splint adherence from heat sensor | - | X | - | - | - |
Complications and AE/SAEs | X | X | X | X | X |