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Table 1 Major endpoints CRCT

From: Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial

Instrument Measurement time points
Enrolment Allocation Post-allocation
-t1 t0 t1 t2 t3 t4 t5
Eligibility screen X       
Informed consent X       
Sociodemographic data X X      
EDSS   X      
SDMT   X      
MS-related data and resource use   X     X X
  Risk knowledge   X    X X X
Attitude    X X X   
Immunotherapy status   X    X X X
Dyadic DCS    X (nurse) X (physician and patient)    
Dyadic MAPPIN’SDM    X (nurse and patient) X (physician and patient)    
HCR trust scale (Physician/Nurse trust)    X X    
PBMS   X    X   X
CPS   X    X   X
Decision autonomy      X X X
CSES   X    X   X
HAQUAMS   X    X   X
HADS   X    X   X
  1. t1 = after last decision coaching; t2 = directly after final physician decision encounter; t3 = two weeks after final physician encounter; t4 = three months after final physician encounter; t5 = six months after final physician encounter. CPS: Control Preference Scale; CSES: Coping self-efficacy scale; DCS: Decisional Conflict Scale; EDSS: Expanded Disability Status Scale; HADS: Hospital Anxiety and Depression Scale; HAQUAMS: Hamburg Quality of Life in MS Scale; HCR trust scale: Health care relationship trust scale; MAPPIN’SDM: Multifocal Approach to Sharing in Shared Decision Making; MMIC: Multi-dimensional measure of informed choice; MS: Multiple Sclerosis; PBMS: Planned Behaviour in MS Scale; SDMT: Symbol Digital Modalities Test.