PD COMM Study

PDComm in royal college blue - trial logo finalA 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.

The PD COMM study is a randomised controlled trial currently open to recruitment.

Design

PD COMM is a  study to evaluate the effectiveness and cost-effectiveness of two types of speech and language therapy (SLT) for people with Parkinson’s disease (PD) who have self reported problems with voice or speech. Participants will be randomised to Lee Silverman Voice Treatment (LSVT), standard NHS SLT or no therapy for at least 12 months (while participating in trial). Participants randomised to the control group can be referred for SLT at the end of trial or, if it becomes clinically necessary during the trial (e.g. within 12 months of randomisation).

The trial will be open label due to the nature of the intervention.

Aim of Study

The primary objective of the trial is to evaluate the clinical and cost-effectiveness of the two types of SLT versus no SLT treatment (control) for people with PD, but the trial will also compare the two types of SLT (LSVT versus standard NHS SLT).

Setting

Community-based therapy in 40 elderly care and neurology units across the UK.

Target population

We intend to recruit 546 patients with PD of any age who report problems with voice or speech.

Intervention

SLT will be administered as per local practice (either in the community or in an out-patient setting). LSVT will be administered in 4 sessions per week for 4 weeks of pre-determined content with homework. NHS SLT will have more variability but typically will be 1 session per week for 6 – 8 weeks of varying content as determined by participant need.

Training will be provided for the Speech and Language therapists where necessary.

Therapists providing the intervention will complete intervention record forms, as used in previous complex intervention trials, to allow monitoring of intervention delivery.

Measurement of outcomes and costs

We will assess the clinical effectiveness in terms of the ability of the therapy to maximise speech intelligibility and communication, and improve the quality of life in people with PD reporting difficulties with speech. We will also assess the quality of life of carers, and a cost-effectiveness analysis will be performed.

Outcome measures will be the self-reported Voice Handicap Index (VHI) as intelligibility is the target of the intervention;  Parkinson's Disease Questionnaire-39 (PDQ-39); Questionnaire on Acquired Speech Disorders; EuroQol (EQ-5D); ICECAP-0; Resource Usage; adverse events and carer quality of life (Parkinson’s Disease Carers’ Quality of Life Questionnaire).

Participants assessments will be completed before randomisation and by post at 3, 6 and 12 months after randomisation.