PD REHAB Trial Update. Francis Dowling 27 th June 2011
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1 PD REHAB Trial Update Francis Dowling 27 th June 2011
2 PD REHAB - Randomised controlled trial to assess the clinical- and cost-effectiveness of physiotherapy and occupational therapy in Parkinson's disease. 750 participants 40 centres Randomised between PT & OT (starting within 4 weeks) versus no therapy. Follow up 15 months
3 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 *
4 PD REHAB What's Changed?
5 PD REHAB What's Changed? Letters of invitation for potential participants have been approved by ethics and are available. Requested by sites that hold lists of people with PD who wish to be informed of potential research that they may be eligible for. Initial Assessment and therapist log forms have been improved, approved and updated after feedback from the therapists
6 PD REHAB What's Changed? Reduced the amount of requests for SAE forms as the previous system was overly complicated with little extra benefit.
7 PD REHAB Therapist Forms Initial Assessment 1. Question added: Will the participant receive any further Occupational therapy / Physiotherapy? Yes No 2. Process changed: Initial assessment to be returned following assessment Therapist Logs 1. Clarification: One to one/ joint/ group session
8 PD REHAB AEs & SAEs Given that PD REHAB is an 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 occurring.
9 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 hospital visit. We will only request further information on being informed that a participant has been hospitalised.
10 PD REHAB Recruitment 420 patients recruited in ~ 24 months 12 months remain ~ 330 recruitments to hit target of 750
11 PD REHAB Recruitment
12 PD REHAB Projections Projections calculated for 39 sites. If 40 sites are active, the final projections are: 575 or 962 per site per year.
13 Participants Recruitment by Site Centre
14 PD REHAB Sites Aberdeen Royal Infirmary Central Middlesex Hospital City Hospital, Birmingham Cumberland Infirmary Darlington Hospital Dorset County Hospital Edith Cavell Hospital Eryri Hospital, Caernarfon Fairfield Hospital, Bury Gloucestershire Royal Hospital Grantham District Hospital Harrogate District Hospital Hereford District General Hull Royal Infirmary Leicester General Hospital Lincoln County Hospital Macclesfield Hospital Mount Gould Hospital NHNN Newmarket Community Hospital Norfolk & Norwich University Hospitals North Devon District Hospital Poole Hospital Princess of Wales Hospital Queen Alexandra Hospital Portsmouth Royal Blackburn Hospital Royal Bournemouth General Hospital Royal Devon & Exeter Hospital Royal Hampshire County Hospital Royal Preston Hospital Salisbury District Hospital Southampton General Hospital St Helens/Whiston Hospital Taunton & Somerset Hospitals Torbay Hospital Walton Centre for N+N Weston General Hospital William Harvey Hospital Yeovil District Hospital
15 PD REHAB Therapy Sites Aberdeen Royal Infirmary, Woodend Day Hospital Norfolk & Norwich University Hospitals Central Middlesex Hospital, Willesden Centre for Health & Rehabilitation Torrington Hospital Rowley Regis Hospital, City Hospital Aldernay Community Hospital Cumberland Infirmary Pendre Day Hospital, Princess of Wales Hospital Shotley Bridge Hospital, Darlington Memorial Hospital, Bishop Auckland General Hospital Petersfield Hospital, St. James Hospital, Queen Alexandra Hospital Atrium Health Centre Royal Blackburn Hospital City Health Clinic, Healthy Living Centre Christchurch Hospital, St.Leonard Day Hospital Llandudno General Hospital Whipton Community Hospital Fairfield Hospital Royal Hampshire County Hospital Gloucester Royal Hospital, Tewkesbury Hospital Royal Preston Hospital Grantham & District Hospital, Pilgrim Hospital Salisbury District Hospital Harrogate District Hospital Ramsey Hospital, Bittem Park Surgery Herefordshire Community Hospitals, Bromyard Community Hospital St Helens/Whiston Hospital Hull Royal Infirmary, Westbourne Avenue NHS Centre Dene Barton Community Unit Loughborough Hospital, Leicester Royal Infirmary, Leicester General Hospital, 1 Spinney Hill Road, Overton House Paignton Hospital Queensway Day Hospital, Yeovil District Hospital Lincoln County Rehab Team, Loath County Hospital Walton Centre Macclesfield District General Hospital, Congleton War Memorial Hospital, Knutsford Community Hospital Weston General Hospital Kent & Canterbury Hospital, QE Queen Mother Hospital Mount Gould Hospital National Hospital for Neurology & Neurosurgery Newmarket Community Hospital William Harvey Hospital
16 Baseline Demographics 68% male 61% have a carer Mean age at randomisation 71 years Mean time since diagnosis 56 months (median time = 30 months)
17 Hoehn & Yahr Staging Stage 1.0 Unilateral involvement only Stage 1.5 Unilateral and axial involvement Stage 2.0 Bilateral involvement without impairment of balance Stage 2.5 Mild bilateral involvement with recovery on retropulsion (pull) test Stage 3.0 Mild to moderate bilateral involvement, some postural instability but physically independent Stage 4.0 Severe disability, still able to walk and to stand unassisted Stage 5.0 Wheelchair bound or bedridden unless aided.
18 Hoehn & Yahr (2) 120 Hoehn & Yahr Scores at Baseline Most participants do not have postural instability at randomisation
19 Activities of Daily Living 200 NEADL Score at Baseline
20 SAEs Per the protocol an SAE is a fall or equipment failure that requires hospitalisation 19 reported SAEs 15 weren t hospitalised 4 were hospitalised 4 hospitalisations were related to falls 0 were related to equipment failure
21 Patient & Public Involvement Newsletters Trial Steering Committee Disseminating Results 10 Top Tip Guides for Patients
22 PD REHAB Data Quality
23 PD REHAB Data Quality Use Version 9 forms only including version 9.2 for the therapist forms and 9.1 for the exit form, with all other forms being version 9.0 Ensure all consent forms are completed fully and accurately to GCP standards
24 PD REHAB Process Quality Recruitment of ineligible patients
25 PD REHAB Process Quality Patients not starting treatment promptly
26 PD REHAB Process Quality Patient crossover rate
27 PD GEN PD GEN DNA bank protocol is 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
28 PD REHAB Support Website Contact us: Cally Rick, Francis Dowling, Ryan Ottridge, David Hingley & Pui Au / 9127 / 9128 or 9129 pd-trials@bham.ac.uk
29 Thank You
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