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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
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