Table 2.
Study schedule and procedures
| Time point | Study period | |||||||||||
| Enrolment | Enrolment | Enrolment | Allocation | Postallocation | End of treatment | |||||||
| -t3
72 hours mTBI |
-t2
2 weeks mTBI |
-t1
6 weeks mTBI |
0 3 months mTBI |
t1 | t2 | t3 | t4 | t5 | t12 | f1
6 months mTBI |
||
| Coinvestigator (initials) | Prestudy screening | Prestudy screening | Prestudy screening | Baseline/ randomisation |
Study visit 1 | Study visit 2 onwards | Last study visit | Outcome measures | ||||
| Enrolment: | ||||||||||||
| Eligibility screen | Research assistant | X | X | |||||||||
| Informed consent | MM | X | ||||||||||
| Allocation | MM | X | ||||||||||
| S-NAB Test (Form 1) | NH | X | X | |||||||||
| S-NAB Test (Form 2) | NH | X | ||||||||||
| DTI test | VN/NR | X | X | |||||||||
| DTI post processing | LKT | X | X | |||||||||
| GAS | NAM (OT-1) and NAMT (OT-2) | X | X | X | X | X | X | X | ||||
| Interventions: | ||||||||||||
| Education component/ symptom(s) evaluation | ED team/RP-1 | X (ED team) |
X (RP-1) |
X (RP-1) |
||||||||
| Individualised structured cognitive rehabilitation | NAM (OT-1) | X | X | X | X | X | X | |||||
| Best standard care | NAMT (OT-2) | X | X | X | X | X | X | |||||
| Outcome measures: | ||||||||||||
| S-NAB test | NH | X | X | |||||||||
| DTI | VN/NR | X | X | |||||||||
| GAS | NAM/NAMT (OT-1/OT-2) |
X | X | X | X | X | X | X | ||||
DTI, Diffusion Tensor Imaging; ED, Emergency Department; GAS, Goal Attainment Scaling; mTBI, mild traumatic brain injury; OT, occupational therapist; RP, rehabilitation medicine physician; S-NAB, Neuropsychological Assessment Battery-Screening Module.