Assessments and measurement time points
| Instrument | Measurement time points | ||||||||
| t−1 | t0 | V1 | V2 | V3 | V4 | V5* | V6* | tX | |
| Month | −1 | 0 | 1 | 3 | 6 | 12 | 18* | 24* | X |
| Eligibility screen | X | ||||||||
| Informed consent | X | ||||||||
| Demographic data | X | ||||||||
| MRI | X | X | X | X | X | X | |||
| Clinical visit | X | X | X | X | X | X | X | X | |
| Relapse history | X | X | X | X | X | X | X | X | |
| Immunotherapy status | X | X | X | X | X | X | X | X | |
| EDSS | X | X | |||||||
| RIKNO | X | ||||||||
| CPS | X | X | |||||||
| Decision satisfaction | X | ||||||||
| Patient activation | X | X | |||||||
| Emotional coping | X | X | |||||||
| Changes in empowerment | X | ||||||||
| Expectancy | X | ||||||||
| Readiness to change | X | X | X | ||||||
| HAQUAMS | X | X | |||||||
| EQ-5D-5L | X | X | X | X | X | ||||
| HADS | X | X | |||||||
| GLTEQ | X | X | |||||||
| BSA | X | X | |||||||
| QHOD2 | X | X | X | ||||||
| myfood24 | X | X | |||||||
| Process evaluation | X | X | X | X | X | X | X | X | |
| Health economic parameters | X | X | X | X | X | ||||
t−1=before enrolment; t0=before allocation; V1–V6=post allocation (V1=visit in month 1; V2=visit in month 3; V3=visit in month 6; V4=visit in month 12; V5=visit in month 18; V6=visit in month 24); tx=after reaching the primary endpoint.
*Only in early recruited PwMS.
BSA, Bewegungs- und Sportaktivität Fragebogen (Physical Activity, Exercise and Sport Questionnaire); CPS, Control Preference Scale; EDSS, Expanded Disability Status Scale; GLTEQ, Godin Leisure-Time Exercise Questionnaire; HADS, Hospital Anxiety and Depression Scale; HAQUAMS, Hamburg Quality of Life in Multiple Sclerosis Scale; PwMS, persons with multiple sclerosis; QHOD2, Questionnaire of Healthy Diet; RIKNO, Risk Knowledge in Relapsing Multiple Sclerosis.