Implementing ENGAGE-PD: Adapting the ENGAGE-PD physical activity coaching intervention for individuals newly diagnosed with Parkinson’s to be delivered by physiotherapists in NHS rehabilitation settings: a feasibility cluster-randomised controlled trial utilising co-design, implementation science principles, and an embedded qualitative component.

Background Parkinson's is a progressive neurological condition affecting around 153,000 UK people. It causes motor and non-motor symptoms, reducing activity levels and quality-of-life. Physical Activity (PA) is movement that increases energy expenditure from resting levels. Previous research suggests people with Parkinson's (PwP) do less PA than people of the same age but PA may have a preventative and disease-modifying effect on Parkinson's. There is little research on interventions to promote PA in newly diagnosed PwP. ENGAGE-PD promotes PA using a 'consultative proactive rehabilitation' coaching intervention that promotes self-management over 14-weeks of therapist input and support. Small US-based cohort studies have shown promising results for the intervention. Research Question What is the feasibility and acceptability and what are the outcomes of the ENGAGE-PD PA coaching programme for individuals with newly diagnosed Parkinson's delivered by physiotherapists in NHS rehabilitation settings? Methods This will involve a feasibility study, influenced by implementation science methodology (the scientific study of methods to promote systematic uptake of clinical research/evidence-informed practice into routine practice). The Consolidated Framework for Implementation Research (CFIR) will influence study structure. A Project Advisory Group (PAG), including five PwP and/or Parkinson's carers, will advise on study design and information. Three work packages will be employed: Web-based engagement with PwP and/or Parkinson's carers around the UK (n=40) using 'Group Concept Mapping' consensus to determine the most important and feasible aspects of ENGAGE-PD to be adapted to UK context. Consensus building using Nominal Group Technique with healthcare professionals, service leads/managers. Six to eight UK sites varying in demographic profile, rurality and service provision with proven Parkinson's intervention research delivery experience, will be recruited via established study team links and with Research Delivery Networks (RDN) support. This will refine core elements of the UK ENGAGE-PD approach, define required local contextualisation and usual care at each site. A feasibility cluster-randomised controlled study in four NHS rehabilitation settings, examining the physiotherapy intervention compared to usual care in 48 people newly diagnosed with Parkinson's (n=12 each cluster, two clusters intervention, two usual care). Systematically assessing barriers and facilitators to implementation, will inform the approach to consider the potential for a larger effectiveness-implementation study. Feasibility outcomes will explore situational and social determinants of implementing ENGAGE-PD, including: feasibility of data collection; participant adherence and acceptability; recruitment and attrition rates; intervention fidelity. There will be an embedded qualitative component using thematic analysis of at least twelve semi-structured interviews with participants and physiotherapy providers to further explore feasibility and acceptability. Candidate outcome measures, employed to inform selection of the most appropriate measures for a fully powered effectiveness-implementation trial, will be measures of PA, self-efficacy, motivation, function and participation. These will be assessed at baseline, 15-weeks, and six-months post-baseline. Anticipated Impact and Dissemination The project will add to the evidence-base for implementing an intervention to promote PA for newly diagnosed PwP within NHS physiotherapy provision. Dissemination will involve: plain English summaries; Parkinson's networks and associated social media; neurology conferences; academic journal and conference proceeding publication.