A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial

Table 2 Time and event schedule

Measure	Enrolment	Assessment time
Measure	Enrolment	Allocation t = 0	3 months	6 months	12 months
Enrolment
Informed consent	✓
Eligibility	✓
Allocation		✓
Interventions
Initial interview log and treatment record form (all sessions)			✓^a
Home-based therapy diary			✓^b
Assessments
Baseline case report form		✓
VHI; PDQ-39; QASD; EQ-5D-5 L; ICECAP-O		✓	✓	✓	✓
Resource Usage Questionnaire			✓	✓	✓
Global rating score (Transition item)			✓
PDQ-Carer		✓	✓	✓	✓
Adverse event log			✓^c
12-month case report form					✓

^aFollowing each therapy session for participants in the two SLT treatment arms only
^bCompleted at home by the participant as recommended in their SLT therapy session
^cOnly required for participants randomised to a treatment arm
Key: EQ-5D EuroQol 5-dimension, 5-level questionnaire, ICECAP-O ICEpop Capabilities Measure for Older Adults, QASD Questionnaire on Acquired Speech Disorders, PDQ-39 Parkinson’s Disease Questionnaire-39, SLT Speech and Language Therapy, VHI Voice Handicap Index

ISSN: 1745-6215