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.
OBJECTIVE: This study aimed to evaluate the first vaginal examination at 8 vs 4 hours after amniotomy-oxytocin after Foley ripening in multiparous labor induction.
STUDY DESIGN: A randomized controlled trial was conducted from October 2021 to September 2022 at the University Malaya Medical Center, Kuala Lumpur, Malaysia. Multiparas at term were recruited at admission for labor induction. Participants were randomized to a first routine vaginal examination at 8 or 4 hours after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to initiate contractions. The 2 primary outcomes were the time from amniotomy to delivery (noninferiority hypothesis) and maternal satisfaction (superiority hypothesis). Data were analyzed using the Student t test, Mann-Whitney U test, and chi-square test (or Fisher exact test), as suitable for the data.
RESULTS: A total of 204 women were randomized, 102 to each arm. Amniotomy to birth intervals were 4.97±2.47 hours in the 8-hour arm and 5.79±3.17 hours in the 4-hour arm (mean difference, -0.82; 97.5% confidence interval, -1.72 to 0.08; P=.041; Bonferroni correction), which were noninferior within the prespecified 2-hour upper margin, and the maternal satisfaction scores (11-point 0-10 numerical rating scale) with allocated labor care were 9 (interquartile range, 8-9) in the 8-hour arm and 8 (interquartile range, 7-9) in the 4-hour arm (P=.814). In addition, oxytocin infusion to birth interval difference was noninferior within the 97.5% confidence interval (-1.59 to 0.23) margin of 1.3 hours. Of the maternal outcomes, the amniotomy to first vaginal examination intervals were 3.9±1.8 hours in the 8-hour arm and 3.4±1.3 hours in the 4-hour arm (P=.026), and the numbers of vaginal examinations were 2.00 (interquartile range, 2.00-3.00) in the 8-hour arm and 3.00 (interquratile range, 2.00-3.25) in the 4-hour arm (P