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. 2021 Feb 16;11(2):e041720. doi: 10.1136/bmjopen-2020-041720

Table 1.

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.