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Table 1 Study assessment

From: Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

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

  1. t-1 = before enrolment; t0 = before randomization; t1 = month 3; t2 = month 6; t3 = month 9; t4 = month 12; t5 = month 15; t6 = month 18; t7 = month 21, t8 = month 24; tx = after the final participant reaches t4 (all participants, who have not reached t8); (x): in case of relapse
  2. CPS Control Preferences Scale, EDSS Expanded Disability Status Scale, HADS Hospital Anxiety and Depression Scale, HAQUAMS Hamburg Quality of Life in MS Scale, PAM Patient Activation Measure, PBMS Planned Behaviour in MS Scale, UNDS United Kingdom Neurological Disability Scale