A multi-centre 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

Cath Sackley, Caroline Rick*, Pui Au, Marian Brady, Gillian Beaton, Christopher Burton, Maria Caulfield, Sylvia Dickson, Francis Dowling, Max Hughes, Natalie Ives, Sue Jowett, Patricia Masterson-Algar, Avril Nicoll, Smitaa Patel, Christina Smith, Rebecca Woolley, Carl E Clarke, PD COMM Collaborative Group

*Corresponding author for this work

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Abstract

Background:Parkinson’s affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to speech and language therapy (SLT) intervention are commonly available: NHS SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals’ needs per local practice typically consisting of 6–8 weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive.
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.
Original languageEnglish
JournalTrials
DOIs
Publication statusAccepted/In press - 27 Apr 2020

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Keywords

  • idiopathic Parkinson's disease
  • Lee Silverman voice treatment
  • speech and language therapy
  • randomised controlled trial
  • dysarthria

Cite this

Sackley, C., Rick, C., Au, P., Brady, M., Beaton, G., Burton, C., Caulfield, M., Dickson, S., Dowling, F., Hughes, M., Ives, N., Jowett, S., Masterson-Algar, P., Nicoll, A., Patel, S., Smith, C., Woolley, R., Clarke, C. E., & PD COMM Collaborative Group (Accepted/In press). A multi-centre 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. Trials. https://doi.org/10.1186/s13063-020-04354-7