Instrument | Measurement time points | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Screening baseline | Allocation | Post allocation | ||||||||||
Month | t−1 | t0 | t1 | t2 | t3 | t4 | t5 | t6 | t7 | t8 | tx | |
− 1 | 0 | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | X | ||
Eligibility screen | X | |||||||||||
Informed consent | X | |||||||||||
Sociodemographic data | X | X | ||||||||||
Randomisation | X | |||||||||||
Relapse history | X | X | X | X | X | X | X | X | X | |||
Extra questions in case of a relapse | ||||||||||||
Relapse questions | (X) | (X) | (X) | (X) | (X) | (X) | (X) | (X) | (X) | |||
Decision autonomy and satisfaction | (X) | (X) | (X) | (X) | (X) | (X) | (X) | (X) | (X) | |||
CPS relapse | X | |||||||||||
PAM and empowerment scale | X | X | X | X | X | |||||||
HAQUAMS | X | X | ||||||||||
EQ-5D | X | X | X | X | X | |||||||
HADS | X | X | ||||||||||
PBMS relapses | X | X | ||||||||||
UNDS | X | X | X | X | X | X | X | |||||
Relapse risk knowledge | X | X | ||||||||||
Physician visit including EDSS | X | X | ||||||||||
Health economic parameters | X | X | X | X | X | X | X | X | X | X |