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Background: Parkinson's disease (PD) is the second commonest neurodegenerative disease in developed countries. Current treatment for PD is pharmacologically focused and can have significant side-effects. There is increasing interest in holistic approaches including mindfulness to help manage the challenges associated with living with PD. We hypothesised that there would be an improvement in PD associated function and wellbeing in participants after participating in a 6-week mindfulness-based lifestyle program, and that these improvements would be sustainable at 6 months. Our primary objective was to determine changes in function and wellbeing associated with PD.Methods: An exploratory prospective, mixed-method, randomised control trial incorporating a before and after design with a waitlist control, with an embedded qualitative component was conducted in 2012-2013. Participants included community living adults with disability congruent to H&Y Stage 2 PD, aged 18-75, fluent in spoken and written English and able to attend at least four of six sessions of the program. Participants were randomised to the intervention or wait-list control groups at two locations. All participants in the wait-list control group eventually received the intervention. Two randomisation codes were created for each location. Allocation to the intervention or wait-list control was by random number generation. The program facilitator and participants were blinded to participant data.Results: Group 1 included 35 participants and group 2 (the waitlist control), 37. Data was analysed from 24 (group 1) and 33 (group 2) participants. The intervention group, compared to the waitlist control, showed a small improvement in function and wellbeing associated with PD immediately after the program (t-score = -0.59) and at 6-month post intervention (t-score = -1.42) as reported by the PDQ-39 SI. However this finding was not significant (p = 0.56 and 0.16 respectively). A small yet significant effect size (β = 0.23) in PDQ-39 ADL was reported in group 1 after 6-months post-intervention. This showed a positive improvement in the ADL as reported by group 1 after 6-months (t-score -1.8, p = 0.04). Four secondary measures are reported.Conclusions: Our findings suggest mindfulness-based lifestyle programs have potential to assist participants in managing the ongoing difficulties associated with a neurological condition such as Parkinson's disease. Importantly, our study shows promise for the long term benefits of such programs. Improvements to participant activities in daily living and mindfulness were retained at 6-months post intervention. A more definitive study should be conducted in a larger sample of PD patients to further explore these findings and their impact on reducing stress and anxiety in PD patients.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000440820 , 17(th) April 2012. [ABSTRACT FROM AUTHOR]

Background: Australia is one of many nations struggling with the challenges of delivering quality primary health care (PHC) to increasing numbers of refugees. The OPTIMISE project represents a collaboration between 12 organisations to generate a model of integrated refugee PHC suitable for uptake throughout Australia. This paper describes the methodology of one component; an outreach practice facilitation intervention, directed towards improving the quality of PHC received by refugees in Australian general practices.Methods: Our mixed methods study will use a cluster stepped wedge randomised controlled trial design set in 3 urban regions of high refugee resettlement in Australia. The intervention was build upon regional partnerships of policy advisors, clinicians, academics and health service managers. Following a regional needs assessment, the partnerships reached consensus on four core areas for intervention in general practice (GP): recording of refugee status; using interpreters; conducting comprehensive health assessments; and referring to refugee specialised services. Refugee health staff trained in outreach practice facilitation techniques will work with GP clinics to modify practice routines relating to the four core areas. 36 general practice clinics with no prior involvement in a refugee health focused practice facilitation will be randomly allocated into early and late intervention groups. The primary outcome will be changes in number of claims for Medical Benefit Service reimbursed comprehensive health assessments among patients identified as being from a refugee background. Changes in practice performance for this and 3 secondary outcomes will be evaluated using multilevel mixed effects models. Baseline data collection will comprise (i) pre-intervention provider survey; (ii) two surveys documenting each practices' structure and approaches to delivery of care to refugees. De-identified medical record data will be collected at baseline, at the end of the intervention and 6 and 12 months following completion.Discussion: OPTIMISE will test whether a regionally oriented practice facilitation initiative can improve the quality of PHC delivered to refugees. Findings have the potential to influence policy and practice in broader primary care settings.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12618001970235 , 05/12/2018, Retrospectively registered. Protocol Version 1, 21/08/2017. [ABSTRACT FROM AUTHOR]