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Table 1 Schedule of assessments

From: A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): study protocol

Visit

1

2

  

3

4

5

6

7

 

Assessment

Screening

Baseline

Week 2

Week 4

Week 6

Week 13

Week 26

Week 39

Week 52

Week 104

Informed consent

x

         

Inclusion and exclusion criteria review

x

x

        

Patient demographics

x

         

Vital signs

x

x

  

x

x

x

x

x

 

Informant demographics

x

         

Patient clinical and medical history

x

         

Physical examination

x

x

      

x

 

Neurological assessment

x

x

      

x

 

Previous medications

x

         

Current medications

x

x

  

x

x

x

x

x

 

Co-morbidities

x

         

Biochemistry profile

x

x

    

x

 

x

 

Full blood count

x

x

    

x

 

x

 

ECG

x

x

    

x

 

x

 

MRI

x

       

x

 

Telephone follow-up

  

x

x

      

Cognitive assessments

VADAS-cog

 

x

  

x

x

x

x

x

 

CGIC

 

x

   

x

x

 

x

 

sMMSE

x

x

   

x

x

 

x

 

Trail Making B

 

x

   

x

x

 

x

 

TICS-M

 

x

    

x

 

x

x

Informant/Patient Questionnaires

EQ-5D

 

x

   

x

x

 

x

 

DAD (informant)

 

x

   

x

x

 

x

 

GHQ12 (informant)

 

x

   

x

x

 

x

 

EQ-5D (informant)

 

x

   

x

x

 

x

 

DEMQOL (informant)

 

x

   

x

x

 

x

 

NPI-D (informant)

 

x

   

x

x

 

x

 

CSRI (informant)

 

x

   

x

x

 

x

 

Service use log

 

x

   

x

 

x

  

Advice sheet

 

x

        

Adverse events

  

x

x

x

x

x

x

x

 

Study drug dispensing

 

x

   

x

x

x

  
  1. ECG electrocardiograph, MRI magnetic resonance imaging, VADAS-cog vascular dementia assessment scale cognitive subscale, CGIC clinical global impression of change, sMMSE standardised Mini-Mental State Examination, TIC-M modified telephone interview for cognitive status, EQ-5D EuroQol group 5 dimensions health questionnaire, DAD disability assessment in dementia, GHQ12 12-item general health questionnaire, DEMQOL dementia quality of life, NPI-D neuropsychiatric inventory caregiver distress, CSRI client service receipt inventory