Background
Methods/design
Participant characteristics
Identification, recruitment and randomisation
Trust | PI |
---|---|
Aneurin Bevan University Health Board | Alistair Church |
Basildon and Thurrock University Hospitals NHS Foundation Trust | Sigurlaud Sveinbjornsdottir |
Betsi Cadwaladr University Health Board | Sam Abraham |
Blackpool Teaching Hospitals NHS Foundation Trust | David McGhee |
Brighton and Sussex University Hospitals NHS Trust | Romi Saha |
Cardiff and Vale University Health Board | Chris Thomas |
Central London Community Healthcare NHS Trust | Ayano Funaki |
East Cheshire NHS Trust | Monty Silverdale |
Gloucestershire Hospitals NHS Foundation Trust | Sangeeta Kulkarni |
Great Western Hospitals NHS Foundation Trust | Graham Lennox |
Guy’s and St Thomas’ NHS Foundation Trust | Thomasin Andrews |
Harrogate and District NHS Foundation Trust | Rosaria Buccoliero |
Heart of England NHS Foundation Trust (now University Hospitals Birmingham NHS Foundation Trust) | Martha Pinkney |
Homerton University Hospital NHS Foundation Trust | Laetitia Sautin |
Hywel Dda University Health Board | Christopher James |
Lancashire Teaching Hospitals NHS Trust | Tahir Majeed |
Leeds Teaching Hospitals NHS Trust | Ioannis Mavroudis |
London North West Healthcare NHS Trust | Judy Anne Juada |
NHS Ayrshire and Arran | Andrew Watt |
NHS Dumfries and Galloway | Shona Donaldson |
NHS Forth Valley | Suvankar Pal |
NHS Greater Glasgow and Clyde | Steven Wishart |
NHS Highland/Argyll and Bute | Martin Wilson |
NHS Lanarkshire | Helen Morgan |
NHS Lothian | Gordon Duncan |
NHS Tayside | Derek Sutherland |
Norfolk and Norwich University Hospitals NHS Trust | Stephanie Cooper |
Norfolk Community Health and Care NHS Trust | Lauren Issacs |
North Bristol NHS Trust | Alan Whone |
Northern Lincolnshire and Goole NHS Foundation Trust | Shankar Kamath |
Pennine Acute Hospitals NHS Trust | Jason Raw |
Powys Teaching UHB | Jane Price |
Royal Devon and Exeter NHS Foundation Trust | Ray Sheridan |
Sandwell and West Birmingham Hospitals NHS Trust | Carl Clarke |
St Helens and Knowsley Hospitals NHS Trust | Dipen Gandecha |
Taunton and Somerset NHS Foundation Trust | Simon Cooper |
The Walton Centre NHS Foundation Trust | Malcolm Steiger |
Torbay and South Devon NHS Foundation Trust | Rachel Nashed |
University Hospitals Bristol NHS Foundation Trust | Theresa Allain |
University Hospitals of South Manchester NHS Foundation Trust (now Manchester University NHS Foundation Trust) | David Ahearn |
Bath and North East Somerset Community Health and Care Services NHS | Veronica Lyell |
Wye Valley NHS Trust | Emma Wales |
Interventions
Outcomes
Primary outcome
Secondary outcomes
Other data collected includes
Adverse events
Data collection
Measure | Enrolment | Assessment time | |||
---|---|---|---|---|---|
Allocation t = 0 | 3 months | 6 months | 12 months | ||
Enrolment | |||||
Informed consent | ✓ | ||||
Eligibility | ✓ | ||||
Allocation | ✓ | ||||
Interventions | |||||
Initial interview log and treatment record form (all sessions) | ✓a | ||||
Home-based therapy diary | ✓b | ||||
Assessments | |||||
Baseline case report form | ✓ | ||||
VHI; PDQ-39; QASD; EQ-5D-5 L; ICECAP-O | ✓ | ✓ | ✓ | ✓ | |
Resource Usage Questionnaire | ✓ | ✓ | ✓ | ||
Global rating score (Transition item) | ✓ | ||||
PDQ-Carer | ✓ | ✓ | ✓ | ✓ | |
Adverse event log | ✓c | ||||
12-month case report form | ✓ |
Treatment dose and fidelity
Process evaluation
-
Qualitative interviews with PD COMM participants
-
Qualitative interviews with PD COMM therapists
-
Critical incident reports
-
Therapist’s questionnaire
Sample size
Statistical analysis
Primary outcome analysis
Secondary outcome analyses
Planned subgroup analyses
Health economics analysis
Dissemination
Roles and responsibilities
Trial Management Group | Data Monitoring Committee |
Professor Catherine Sackley (chief investigator) | Dr Carl Counsell (chair), Consultant Neurologist, University of Aberdeen |
Ms Pui Au | |
Ms Gillian Beeston | Dr Katherine Deane, Senior Lecturer, University of East Anglia |
Professor Marian Brady | |
Professor Christopher Burton | Dr Louise Hiller, Statistician, University of Warwick |
Ms Maria Caulfield | |
Professor Carl E Clarke | Trial Steering Committee |
Ms Sylvia Dickson | Dr Lisa Shaw (chair), Senior Research Associate, University of Newcastle upon Tyne |
Dr Sue Jowett | |
Dr Patricia Masterson Algar | Mr Chris Jeffery, Patient and Public Involvement Representative |
Dr Avril Nicoll | |
Mrs Smitaa Patel | Ms Michelle Collinson, Senior Medical Statistician, University of Leeds |
Dr Cally Rick | |
Mrs Natalie Rowland | Dr Linsay Pennington, Senior Lecturer and Speech and Language Therapist, University of Newcastle upon Tyne |
Dr Christina Smith | |
Ms Rebecca Woolley | Professor Catherine Sackley, Professor of Rehabilitation, King’s College London |
Former members | Dr Paul Worth, Consultant in Neurology, Cambridge University Hospitals NHS Foundation Trust |
Mr Francis Dowling | |
Mr Max Hughes | |
Former member: | |
Mr John Carrington, Patient and Public Involvement Representative | |
Professor Adam Gordon, Professor in Medicine of Older People, University of Nottingham | |
Dr Simon Horton, Lecturer and Speech and Language Therapist, University of East Anglia |