Table 3 Outcome measures
Domain | Measure(s) | Timepoint (week) |
|---|---|---|
Motor and non-motor PD symptoms | Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) during “On” | 0, 8, 26, 52 and 56–60 |
MDS-UPDRS part III during “Off” (optional) | 0, 8, 26, 52 and 56–60 | |
Wearable sensor (optional) | 0, 26 and 56–60 | |
Depression | Beck Depression Inventory (BDI-II) | 0, 26, 52 and 56–60 |
Patient Health Questionnaire 9 (PHQ-9) | 0, 8, 26 and 52 | |
Anxiety | Parkinson Anxiety Scale (PAS) | 0, 8, 26 and 52 |
Cognitive function | Montreal Cognitive Assessment (MoCA) | 0, 8, 26, 52 and 56–60 |
Health-related Quality of life | EQ-5D-5L | 0, 8, 26 and 52 |
Capability | ICECAP-O | 0, 8, 26 and 52 |
Overall clinical effectiveness | Clinical Global Impression (CGI) | 0, 8, 26 and 52 |
Health and social care resource use | Modified Client Service Receipt Inventory (CSRI) which incorporates the modified iVICQ | 0, 8, 26 and 52 |
Levodopa-equivalence dose | Levodopa-equivalence dose | 0, 8, 26 and 52 |
Changes in medication | Changes in concomitant medication | 0, 8, 26, 52 and 56–60 |
Side effects | Modified Toronto Side Effects Scale and reporting of other adverse events | 0, 8, 26 and 52 |
Carer-reported outcomes: | ||
Carer burden | EQ-5D-5L and Quality of Life questionnaire for carers (QOL carers) will be completed if the participant has a carer | 0, 8, 26 and 52 |
Number of dropouts | Number of participants who dropout from the trial | 8, 26 and 52 |