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.

Clinical Trials, Phase III as Topic Cost-Benefit Analysis Humans Language Therapy / methods Multicenter Studies as Topic Parkinson Disease / complications Quality of Life Randomized Controlled Trials as Topic Speech Therapy / methods Surveys and Questionnaires United Kingdom Voice Voice Disorders / etiology
Dysarthria Idiopathic Parkinson’s disease Lee Silverman voice treatment Randomised controlled trial Speech and language therapy

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
27 May 2020
Historique:
received: 19 02 2020
accepted: 27 04 2020
entrez: 29 5 2020
pubmed: 29 5 2020
medline: 20 2 2021
Statut: epublish

Résumé

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

Sections du résumé

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

Identifiants

DOI: 10.1186/s13063-020-04354-7 PMID: 32460885 PMC: PMC7251680
pubmed: 32460885
doi: 10.1186/s13063-020-04354-7
pii: 10.1186/s13063-020-04354-7
pmc: PMC7251680
doi:

Types de publication

Clinical Trial Protocol Comparative Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

436

Subventions

Organisme : Department of Health
ID : 10/135/02
Pays : United Kingdom
Organisme : Chief Scientist Office
ID : SCAF/18/01
Pays : United Kingdom
Organisme : Health Technology Assessment Programme
ID : 10/135/02

Investigateurs

A Church (A)
A Davey (A)
C Gallagher (C)
A Conroy (A)
S Bailey (S)
B Done (B)
D Davies (D)
S Sveinbjornsdottir (S)
M Kasti (M)
K Allen (K)
J Colnet (J)
J Riches (J)
L Kittridge (L)
L Morris (L)
C Waszkiewicz (C)
V Lyell (V)
V Page (V)
N Bassford (N)
H Rayner (H)
E Henderson (E)
S Abraham (S)
J V Hindle (JV)
S Jones (S)
P Martin-Forbes (P)
C Watkins (C)
A Roberts (A)
E Newcombe (E)
L Bibby (L)
L Matthews (L)
J Roberts (J)
S Thomas (S)
H Hawthorne (H)
K Clewley (K)
S Lord (S)
J Roberts (J)
G Bretag (G)
S Noble (S)
D McGhee (D)
H Mcclure (H)
A Ling Zhi Teo (ALZ)
R Wheeldon (R)
C Wilkinson (C)
M Oprea (M)
G Van Duyvenvoorde (G)
N Wilson (N)
L Evans (L)
R Belshaw (R)
A Clarke (A)
M Turner (M)
C Thompson (C)
R Saha (R)
J Aram (J)
D Mullan (D)
J Newman (J)
K Micabel (K)
H Robinson (H)
K Chick (K)
J Gaylard (J)
J Cochrane (J)
E C Thomas (EC)
A Kissick (A)
P Wright (P)
B Mohamed (B)
S Mahon (S)
T Williams (T)
S Appleton (S)
N Elliott (N)
L Evans (L)
J Ridley (J)
A Funaki (A)
P Daly (P)
J Hackworth (J)
K Timms (K)
L Evison (L)
A Bajracharya (A)
M Silverdale (M)
K Andrews (K)
A Davies (A)
R Bedford (R)
A Jones (A)
D Mournfield (D)
L Howieson (L)
V Price (V)
J Hunter (J)
A Baggs (A)
L Evans (L)
R Norton (R)
M Holland (M)
K Pointon (K)
S Kulkarni (S)
S Bobeldijk (S)
S Beames (S)
J Cavanagh (J)
S Sudlow (S)
G Lennox (G)
R Whittaker (R)
D Nelson (D)
S Pegler (S)
C Drayson (C)
P Turner (P)
J Stockwell (J)
T Andrews (T)
E White (E)
E Turner (E)
T Burnay (T)
C Hickey (C)
S Warner (S)
R Buccoliero (R)
C Isles (C)
C Stemp (C)
J Guy (J)
C Bennett (C)
S Smith (S)
P Randall (P)
L Ware (L)
J Cann (J)
L Sautin (L)
S Grobler (S)
S Adjei (S)
A Hankin (A)
D Ovayolu (D)
M Dobbs (M)
O Joyce (O)
R Humphreys (R)
A Jha (A)
C Holbrook (C)
K Rowsell (K)
F Johnson (F)
H Thornley (H)
S Conway (S)
C James (C)
S Murrow (S)
M Hughes (M)
K Pope (K)
C MacPhee (C)
E Williams (E)
R Hughes (R)
A Evans (A)
A Richmond (A)
K Pilborough (K)
K Campbell (K)
S E Davies (SE)
A Taylor (A)
S Thomas (S)
D Asandei (D)
T Majeed (T)
J Dawber (J)
S Furey (S)
A Oppetit (A)
J Birt (J)
M Hare (M)
V Fleming (V)
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S Sharp (S)
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S Butterworth (S)
E Sacre (E)
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C Arnold (C)
K Brown (K)
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L Hyne (L)
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J Burns (J)
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E Newman (E)
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C Douglas (C)
C Cooter (C)
J Bushell (J)
R Sheridan (R)
C Browning (C)
K Polverino (K)
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A Foden (A)
R James (R)
S Hayes (S)
L Roberts (L)
E Davis (E)
C Clarke (C)
D Nicholl (D)
A Majeed (A)
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N Stapleton (N)
U Magennis (U)
R Vernall (R)

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Auteurs

C M Sackley (CM)

Population Health Sciences, Addison House, King's College London, Guy's Campus, London, SE1 1UL, UK.
School of Health Science, University of Nottingham, QMC, Nottingham, NG7 2HA, UK.

C Rick (C)

Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK. caroline.rick@nottingham.ac.uk.
Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK. caroline.rick@nottingham.ac.uk.
ORCID: 0000-0001-7713-9834

P Au (P)

Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.

M C Brady (MC)

NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.

G Beaton (G)

Queen Elizabeth Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.

C Burton (C)

School of Allied and Public Health Professions, Canterbury Christ church University, Canterbury, CT1 1QU, UK.

M Caulfield (M)

Bangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University, Bangor, UK.

S Dickson (S)

NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.

F Dowling (F)

Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, CB2 0QQ, UK.

M Hughes (M)

Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.

N Ives (N)

Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.

S Jowett (S)

Health Economics, University of Birmingham, Birmingham,, B15 2TT, UK.

P Masterson-Algar (P)

Bangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University, Bangor, UK.

A Nicoll (A)

NMAHP Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.

S Patel (S)

Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.

C H Smith (CH)

Division of Psychology and Language Science, Faculty of Brain Sciences, University College London, London, UK.

R Woolley (R)

Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.

C E Clarke (CE)

Institute for Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Department of Neurology, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham,, B18 7QH, UK.

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