PD REHAB Trial Update Cally Rick 8 th June 2010
PD REHAB Randomised controlled trial to assess the clinical- and cost-effectiveness of physiotherapy and occupational therapy in Parkinson's disease.
PD REHAB Design 750 participants 40 centres Randomised between PT & OT (starting within 4 weeks) versus no therapy. Follow up 15 months
PD REHAB Participants Inclusion Criteria Idiopathic PD defined by the UK PDS Brain Bank Criteria Report limitations in activities of daily living The investigator is uncertain that the patient will require OT and/or PT during the 15 months of the trial Exclusion Criteria Dementia as usually defined clinically by the patient s physician. Received OT or PT in the last one year
PD REHAB Assessments Measure Completed Assessment time by Baseline 3 months 9 months 15 months Hoehn and Yahr stage Clinician Medication Clinician NEADL Patient PDQ 39 Patient EQ 5D Patient Resource use questionnaire Patient Carer SF 12 Carer
PD REHAB Assessments (2) Active treatment arm Therapists logs: Initial assessment logs Treatment logs for each subsequent visit. Please also complete logs for any participants in the control group who cross-over.
PD REHAB AEs & SAEs Given that PD REHAB is a extremely low risk trial, we are recording a limited range of AEs & SAEs: Falls Equipment failure Serious enough to require medical attention, either GP, ambulance or hospital visit. We will request further information on being informed by the participants of any of these events occuring.
PD REHAB Governance Substantial amendments were submitted in April 09 and March10. Amendments are primarily* modifications to paperwork that do not affect the day to day management of trial. A further amendment will be submitted which will include letters of invitation for potential participants. * Except change to exclusion criteria in April 09
PD REHAB Approved Sites City Hospital, Birmingham Torbay Hospital QE Hospital, Birmingham Gloucestershire Royal Hospital Harrogate District Hospital Aberdeen Royal Infirmary Yeovil District Hospital Lincoln County Hospital Eryri Hospital, Caernarfon Salisbury District Hospital Southampton General Hospital Central Middlesex Hospital, London St Helens/Whiston Hospital Grantham District Hospital Royal Preston Hospital Heartlands Hospital, Birmingham Royal Hampshire County Hospital Dorset County Hospital Royal Bournemouth General Hospital Poole Hospital Macclesfield Hospital William Harvey Hospital Taunton & Somerset Hospitals (Musgrove Park) Leicester General Hospital Hereford District General Watford General Hospital Royal Devon & Exeter Hospital Queen Alexandra Hospital Portsmouth Mount Gould Hospital (Plymouth Teaching Hospitals) Darlington Hospital Princess of Wales Hospital Walton Centre for N+N
PD REHAB Approved Sites Awaiting R&D approval Norfolk & Norwich University Hospitals Edith Cavell Hospital, Peterborough Royal Blackburn Hospital Completing local application Addenbrookes (/Newmarket/West Suffolk) Hospital National Hospital for Neurology & Neurosugery Bronylls Hospital Fairfield Hospital, Bury Hull Royal Infirmary + 2 possible sites
PD REHAB Recruitment 30 25 20 Patient Recruitment 100 90 80 70 60 15 10 5 50 40 30 20 10 Recruitment Cumulative 0 Jul-09 Aug- 09 Sep- 09 Oct- 09 Nov- 09 Dec- 09 Jan- 10 Feb- 10 Mar- 10 Apr- 10 May- 10 0
Participants Recruitment by Site 12 11 10 9 8 7 6 5 4 3 2 1 0 Centre
PD REHAB Projections 800 700 600 500 400 300 200 Projection @6 Projection @10 Actual Projections calculated for 32 sites. If 40 sites are active, the final projections are: 575 participants @6 or 962 participants @10 per site per year. 100 0 Jul-09 Sep-09 Nov-09 Jan-10 Mar-10 May-10 Jul-10 Sep-10 Nov-10 Jan-11 Mar-11 May-11 Jul-11 Sep-11 Nov-11 Jan-12 Mar-12 May-12
Further Sites We are still accepting further sites that are keen to be involved with the trial on an individual basis.
PD GEN A substantial amendment to the PD GEN DNA bank protocol has been approved to allow participants in PD REHAB and their carers to provide PD GEN samples. Sites need ethical approval for PD GEN as well as PD REHAB
PD REHAB Support Website http://www.pdrehab.bham.ac.uk/ Therapists forum PPI Panel Site visits Contact us: Cally Rick, Francis Dowling, Ryan Ottridge, Dani Scott & David Hingley. 0121 415 9125 / 9127 / 9128 or 9129 pd-trials@bham.ac.uk
Thank You