Title: A Randomised Controlled Trial of the Effectiveness of PDSAFE to prevent Falls among People with Parkinsons Disease
Funder: Department of Health (England)

Abstract: DESIGN: Multi-centred individually randomised two-group controlled trial proceeded by 3-months monitoring ofindividual fall rate and a pilot study. A qualitative study of personal insights and an economic evaluation will run in paralleland be integrated with the main RCT.SETTING: Participants for the main trial will be identified from four areas in the south of England. We will work with themembers of the DeNDRoN network as well as PD nurses and PD specialists to recruit participants. We will also approachParkinson’s UK local support groups primary care consortia and outpatient services.TARGET POPULATION: People with a confirmed diagnosis of PD live at home have experienced at least one fall in theprevious 12 months and can understand and follow instructions will be eligible for recruitment to the trial.RANDOMISATION: We will recruit 600 to the pre-randomisation falls collection period we estimate with drop outsapproximately 540 will be randomly allocated to one of two groups; intervention or control. Allocation will be stratified bycentre and allocated in blocks with random size of 2 46 or 8. The treating therapist will access allocation on the CTUwebsite.HEALTH TECHNOLOGY: All participants will have usual care. The control group will receive a standardised DVD with arelaxation programme. The experimental group will participate in PDSAFE a personalised home-basedprogramme of exercises and strategies for fall prevention to be delivered by physiotherapists with specific training in theintervention and use of DVD and tablet computer technology. The novelty of the treatment lies in both the content (disease specific exercisesand strategies for limiting instability use of motor relearning and cognitive awareness) and delivery (personalised feedbackusing DVD for adherence and self-management). The programme comprises: a] exercises for balance gait and muscleweakness b] strategies for reducing freezing encouraging stability and gait efficacy c] feedback model to promote learningand adherence. Personal sessions with required exercises and will be recorded on DVD and returned so information andinstructions can be replayed at home; DVD will be developed with the PwPD. The frequency of the intervention sessionswill be faded over time one hour twice a week for a month once a week for two months followed by once a month for 3months. The control group will receive usual care and a DVD with a relaxation programme.MEASUREMENT OUTCOME:a] Pre-randomisation fall collection period: Those who meet the inclusion criteria will be asked to prospectively record fallevents using a monthly diary sheet for 3 months between recruitment and randomisation. These findings will be used forcomparison with post-intervention fall rate. b] The assessments will take place in participants’ homes at baseline 3 6 and12 months post-randomisation and will be completed by the assessor who will be blinded to group allocation. c] Baselineonly: At baseline a medical history structured to include co-morbidities will be taken disease severity medication and handgrip will be recorded. d] Our primary outcome is risk of repeat falling between 0-6 months. Fall data will be collectedthrough self-completed monthly diary sheets from baseline to 12 months post-randomisation. e] Secondary outcomes willinclude risk of repeat falling 6-12 months rate of falling 0-6 and 6-12 months injurious falls and near falls (from the falldiary) a measure of balance turning mobility and quality of life. Individual levels of activity will be recorded using thePhone-FITT questionnaire.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS;NEUROLOGICAL