Abstract
Introduction
Parkinson disease (PD), a neurodegenerative disorder that progresses over time, is steadily growing in number and prevalence worldwide. PD in Malaysia is expected to increase five-fold by 2040 from the existing estimate of 20,000 patients in 2018. Treatment program of PD in Malaysia is rather unstructured, and there is no known comprehensive PD family caregiver training program available to date. To ensure the quality of a program, it must be tested for feasibility, effectiveness and sustainability. This paper describes the protocol of a study that evaluates the effectiveness of a structured, comprehensive training program of family caregiver to persons with PD in comparison to usual care.
Materials and methods–Study protocol
A total of 60 pairs of persons with PD of stage II and III, and their primary family caregiver will be recruited and allocated into either an experimental or a control group for 12 weeks of intervention. The experimental group will undergo initial training from multi-disciplinary healthcare providers and will be given a physical module containing weekly tasks that must be practised at home. While the control group will receive a usual care. Both groups will be assessed in terms of physical functions, functional mobility, quality of life (QoL), caregiver burden and knowledge using standardised assessment tools namely Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Timed Up and Go (TUG) test, Parkinson’s Disease Questionnaire (PDQ-39), European Quality of Life five-dimensions (EQ-5D), Malay version of Zarit Burden Interview (MZBI) and Knowledge of Parkinson Disease Questionnaire (KPDQ). In addition, the feasibility and sustainability of the interventions will be evaluated, alongside its cost-effectiveness based on the average and incremental cost effectiveness ratio. All data will be analysed using descriptive and inferential statistics, particularly mixed model ANOVA.
Discussion
There is a significant gap in the literature pertaining family caregiver training programs for people with PD. Documented programs are lacking in term of comprehensiveness of content, application approach and the measurement of training outcomes including the program cost-effectiveness. The feasibility and effectiveness of such training program in a Malaysian setting also requires investigation due to differences in living environment, support system and population’s perception. This study will assist to fulfil the existing literature gap and demonstrate the potential benefit of caregiver involvement in mediating the care and therapy for PD in the home setting. Optimum knowledge and skills gained through the training are expected to enhance the confidence and ability of the family caregivers and may possibly reduce their perceived caregiving burden.
Protocol registration
The protocol of this study is registered in the Australian-New Zealand Clinical Trial Registry (ANZCTR) with a registration number ACTRN12623000336684.