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Table 2 Study assessment schedules

From: The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials

Assessment

Baseline

At discharge

1 Week

4 Weeks

12 Weeks

26 Weeks

30 Weeks

52 Weeks

Consent and randomise

x

       

Contact details

x

f,e

 

a

    

Living circumstances

x

f

 

x

e

x

 

x

Training (physio, etc.)

  

e

e

 

e

  

10 Outcome-smRSq (mRS) [26, 31–33]

a

  

a

 

x

 

x

Depression diagnosis

x

f,e

 

a

x

x

 

x

PHQ2 [56]

f,e

       

PHQ9 [43]

a

  

a

 

a

 

a

MHI 5 [37–39]

     

f,e

 

f,e

MADRS [40, 41]

    

e

e

 

e

Emotionalism

     

e

  

DSM IV for depression [42]

    

e

e

e

e

SIS [34–36]

     

x

 

x

Fatigue subscale SF36 [44, 45]

   

x

e

x

 

x

Cognition (TICSm) [46]

     

a

 

a

Cognition (MoCA) [47]

e

    

e

  

EQ5D-5 L [48]

  

e

e

 

x

 

x

EQD thermometer

     

a

 

a

SF12 [59]

       

a

Adverse events

 

f,e

e

a,e

e

x

 

x

Adherence to IMP

 

f

e

a,e

e

x

  

All medications

x

f

 

a

 

x

 

a

Retrieve residual capsules (pill count)

    

e

x

  

Physical therapy received

   

e

   

e

Resource use over 12 months

       

x

  1. f = FOCUS, a = AFFINITY, e = EFFECTS, x = completed in all three trials