|
Pre-study screening/consent
|
Baseline
|
Randomisation /Clinical visit 1
|
Clinical visit 2
|
Clinical visit 3
|
6 months follow up
|
12 months follow up
|
---|
−1
|
0
|
T1a
|
T2b
|
T3
|
F1
|
F2
|
---|
Enrolment
|
Eligibility screen
|
X
| | | | | | |
Informed consent
|
X
| | | | | | |
Allocation
| | |
X
| | | | |
Measurements
|
FFI pain
| |
X
| | | |
X
|
X
|
FFI disability
| |
X
| | | |
X
|
X
|
FFI functional limitation
| |
X
| | | |
X
|
X
|
FIS-RA
| |
X
| | | |
X
|
X
|
EQ-5D-5 L
| |
X
| | | |
X
|
X
|
HAQ
| |
X
| | | |
X
|
X
|
DAS-28
| |
X
| | | |
X
|
X
|
CSRI
| | | | | |
X
|
X
|
Interventions
|
Customised foot orthoses
| | |
X
|
X
|
X
| | |
Prefabricated foot orthoses
| | |
X
| |
X
| | |
- FFI Foot function index, FIS-RA Foot impact scale for rheumatoid arthritis, HAQ Health assessment questionnaire, DAS-28 disease activity score 28 joints, CSRI Client service receipt inventory
- T1a randomisation was triggered by the intervention clinician at the first clinical visit using the online system
- T2bfor customised FO group, manufacture required an additional fitting appointment approximately 2 weeks following clinical visit 1