Activity/assessment | Staff member | Time | Pre-study | Pre-study baseline | 2 | 4 | 6 | 8 | 10 | 12 | 16 | 24 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Usability study | Interviewer | N/A | X | |||||||||
Focus group | 90 | |||||||||||
SUS | N/A | |||||||||||
Consent Form | Study coordinator | 5 | X | X | X | X | X | X | ||||
Inclusion/exclusion criteria | Study coordinator | N/A | X | |||||||||
DSM-5 criteria | Interviewer | N/A | X | |||||||||
Cognitive assessment | Interviewer | 106 | ||||||||||
MMSE | 20 | X | X | X | X | X | ||||||
ADASCog | 40 | X | X | X | X | X | ||||||
WAIS III: Calculus | 5 | X | X | X | X | X | ||||||
WAIS III: Digit Span | 5 | X | X | X | X | X | ||||||
WAIS III: Coding digit symbol | 2 | X | X | X | X | X | ||||||
TMT A and B | 10 | X | X | X | X | X | ||||||
Semantic and phonologic verbal fluency | 4 | X | X | X | X | X | ||||||
CAMCog matrices | 5 | X | X | X | X | X | ||||||
Clock Drawing Test | 10 | X | X | X | X | X | ||||||
Pattern recognition test | 5 | X | X | X | X | X | ||||||
ADL/iADL (InterRAI HC) | Interviewer | N/A | X | X | X | X | X | |||||
Quality of life | Interviewer | 20 | ||||||||||
EQ5D-5 L | 5 | X | X | X | X | X | ||||||
LSNS (Luben) | 15 | X | X | X | X | X | ||||||
Mood | Interviewer | 15 | ||||||||||
GDS | 15 | X | X | X | X | X | ||||||
Patient-carer relationship | N/A | |||||||||||
QCPR | X | X | X | X | X | |||||||
Technological assessment | Interviewer | N/A | ||||||||||
ETUQ | X | |||||||||||
Randomisation | Study coordinator | N/A | X | |||||||||
Treatment (group-specific) | Study coordinator | N/A | X | X | X | X | X | X | ||||
Termination Form | Study coordinator | N/A | As needed throughout the study | |||||||||
Adverse Event Form | Study coordinator | N/A | As needed throughout the study | |||||||||
Progress notes | All | N/A | X | X | X | X | ||||||
Communication log | All | N/A | Every phone or in-person contact outside of regular visit |