Methods/Design:PD COMM is a phase III, multicentre, 3-arm unblinded randomised controlled trial. 546 people with idiopathic Parkinson’s, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation.
Primary outcome:Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5L; ICECAP-O; resource utilisation; adverse events and carer quality of life. A mixed methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation.
The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK.
Discussion:The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with Parkinson’s compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions.
|Publication status||Accepted/In press - 27 Apr 2020|
- idiopathic Parkinson's disease
- Lee Silverman voice treatment
- speech and language therapy
- randomised controlled trial