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

Journal article

Sackley, C. M., Rick, C., Au, P., Brady, M. C., Beaton, G., Burton, C., Caulfield, M., Dickson, S., Dowling, F., Hughes, M., Ives, N., Jowett, S., Masterton-Algar, P., Nicoll, A., Patel, S., Smith, C. H., Woolley, R. and Clarke, C. E. 2020. 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. Trials. 21 (436). https://doi.org/10.1186/s13063-020-04354-7
AuthorsSackley, C. M., Rick, C., Au, P., Brady, M. C., Beaton, G., Burton, C., Caulfield, M., Dickson, S., Dowling, F., Hughes, M., Ives, N., Jowett, S., Masterton-Algar, P., Nicoll, A., Patel, S., Smith, C. H., Woolley, R. and Clarke, C. E.
Abstract

Background
Parkinson’s disease (PD) 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: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals’ needs per local practice typically consisting of six to eight 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, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those 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-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. 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 PD 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.

Trial registration
International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016.

KeywordsParkinson's disease; Speech and language therapy; Lee Silverman Voice Treatment
Year2020
JournalTrials
Journal citation21 (436)
PublisherBioMed Central
ISSN1745-6215
Digital Object Identifier (DOI)https://doi.org/10.1186/s13063-020-04354-7
Official URLhttps://doi.org/10.1186/s13063-020-04354-7
Publication dates
Online27 May 2020
Publication process dates
Accepted27 Apr 2020
Deposited02 Jun 2020
Output statusPublished
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Masterson-Algar, P., Burton, C., Rycroft-Malone, J., Sackley, C.M. and Walker, M.F. 2014. Towards a programme theory for fidelity in the evaluation of complex interventions. Journal of Evaluation in Clinical Practice . 20 (4), pp. 445 - 452. https://doi.org/10.1111/jep.12174
Investigating the organisational impacts of quality improvement: a protocol for a realist evaluation of improvement approaches drawing on the Resource Based View of the Firm.
Burton, C., Rycroft Malone, J., Robert, G., Willson, A. and Hopkins, A. 2014. Investigating the organisational impacts of quality improvement: a protocol for a realist evaluation of improvement approaches drawing on the Resource Based View of the Firm. BMJ Open. 4:e005650. https://doi.org/10.1136/bmjopen-2014-005650
Resource based view of the firm as a theoretical lens on the organisational consequences of quality improvement.
Burton, C. and Rycroft-Malone, J. 2014. Resource based view of the firm as a theoretical lens on the organisational consequences of quality improvement. International Journal of Health Policy and Management. 3 (3), pp. 113 - 115. https://doi.org/10.15171/ijhpm.2014.74
The study protocol of: 'Initiating end of life care in stroke: clinical decision-making around prognosis'.
Burton, C., Payne, S., Turner, M., Bucknall, T., Rycroft-Malone, J., Tyrell, P., Horne, M., Ntambwe, L.I., Tyson, S., Mitchell, H., Williams, S. and Elghenzai, S. 2014. The study protocol of: 'Initiating end of life care in stroke: clinical decision-making around prognosis'. BMC Palliative Care. 13 (55). https://doi.org/10.1186/1472-684X-13-55
Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial.
Thomas, L.H., Watkins, C.L., Sutton, C.J., Forshaw, D., Leathley, M.J., French, B., Burton, C., Cheater, F., Roe, B., Britt, D., Booth, J., McColl, E., The ICONS Project Team and The ICONS Patient, Public and Carer Involvement Groups 2014. Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial. Trials. 15 (509). https://doi.org/10.1186/1745-6215-15-509
What is rehabilitation potential? Development of a theoretical model through the accounts of healthcare professionals working in stroke rehabilitation services
Burton, C.R., Horne, M., Woodward-Nutt, K., Bowen, A. and Tyrrell, P. 2014. What is rehabilitation potential? Development of a theoretical model through the accounts of healthcare professionals working in stroke rehabilitation services. Disability and Rehabilitation. 37 (21), pp. 1955-1960. https://doi.org/10.3109/09638288.2014.991454