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Table 2 Data collection by visit

From: The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial

Months from BL

BL

T1

F1

T2

F2

T3

F3

F4

F5

F6

0

0.5

1

1.5

2

2.5

3

4

5

6

Procedures

 Consent

X

X

X

X

X

X

X

X

X

X

 History, or interim history

X

X

X

X

X

X

X

X

X

X

 Demographics

X

-

-

-

-

-

-

-

-

-

 Review of inclusion/exclusion

X

-

-

-

-

-

-

-

-

-

 Psychosocial intervention

X

-

X

-

X

-

X

X

X

X

 Dispensing of study drug

X

-

X

-

X

-

X

X

X

-

 Review visit schedule

X

X

X

X

X

X

X

X

X

X

 Review of compliance

-

X

X

X

X

X

X

X

X

X

Assessments

 NPI

X

-

X

-

X

-

X

X

X

X

 mADCS-CGIC

X

-

X

-

X

-

X

X

X

X

 DAIR

X

-

X

-

X

-

X

X

X

X

 ADL

X

-

-

-

X

-

-

X

-

X

 Dependence Scale

X

-

-

-

X

-

-

X

-

X

 Cognitive battery

X

-

-

-

X

-

-

X

-

X

 EQ-5D-5 L

X

-

-

-

-

-

X

-

-

X

 RUD-lite

X

-

-

-

-

-

X

-

-

X

 Diagnostic criteria for apathy

X

-

-

-

-

-

-

-

-

-

Safety measurements

 Vital signs

X

-

X

-

X

-

X

X

X

X

 Electrolyte panel

X

-

X

-

X

-

X

X

X

X

 Adverse events

X

X

X

X

X

X

X

X

X

X

 Review ECG

X

-

X

-

X

-

X

X

X

X

  1. BL baseline visit, F scheduled follow-up visits, T scheduled telephone contact, NPI Neuropsychiatric Inventory, mADCS-CGIC modified AD Cooperative Study Global Impression of Change, DAIR Dementia Apathy Interview and Rating, ADL Activities of Daily Living, EQ-5D-5 L Euro Quality of Life, RUD-lite Resource Utilization in Dementia-Lite, ECG electrocardiogram
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Trials

ISSN: 1745-6215