A Randomized Controlled Trial on Rehabilitaºon through Caregiver

A Randomized Controlled Trial on Rehabilita3on through Caregiver-­‐Delivered Nurse-­‐
Organized Service Programs for Disabled Stroke Pa3ents in Rural China (The RECOVER Trial) : Design and Ra3onale Lijing L. Yan, Shu Chen, Bo Zhou, Jing Zhang, Bin Xie, Rong Luo, Ninghua Wang, Richard Lindley, Yuhong Zhang, Yi Zhao, Xian Li, Xiao Liu, Nicholas Peoples, Janet Prvu BeBger, Craig Anderson, Sarah E Lamb, Yangfeng Wu, Jingpu Shi Presenter: Shu Chen, Duke Kunshan University, shu.chen@duke.edu
Trial Flowchart (aNer pilot test) Background Eligible stroke paJents (n=200) Stroke is the leading cause of death and disability in rural China. For the vulnerable populaJon of stroke paJents residing in resource-­‐limited rural areas, secondary prevenJon and rehabilitaJon are largely unavailable, and where present, are far below evidence-­‐based standards. The current study aims to develop and implement an evidence-­‐
based, simplified stroke rehabilitaJon delivery program that uJlizes nurses and family caregivers in rural China, and evaluate its feasibility and effecJveness. Pre-­‐discharge assessment (BI, FAC, mRS) 3-­‐month telephone follow up (BI, FAC, mRS) Picture cited from: Xu G, Ma M, Liu X, Hankey GJ. Is there a stroke belt in China and why? Stroke 2013; 44(7):1775-­‐83. Methods/Design Control arm: Usual care (n=100) This two-­‐year randomized controlled trial is being conducted in Zhangwu County Hospital, Liaoning Province, Qingtongxia County Hospital, Ningxia Hui Autonomous Region and Dianjiang County, Chongqing City starJng from November 2014. Eligible and consenJng stroke inpaJents are recruited and randomized into either control or intervenJon group. A total of 200 paJents are to be recruited by trained nurses in nine months. Nurses in the county hospital are trained by rehabilitaJon specialists and in turn train the family caregivers of paJents in the intervenJon group with the aid of a self-­‐
designed easy-­‐to-­‐understand picture-­‐rich rehabilitaJon manual. They also provide telephone follow-­‐up for three Jmes a\er paJents are discharged. The recruitment, baseline, intervenJon, follow-­‐up care and evaluaJon are guided by the Electronic Data Capture (EDC) system specifically designed for this study to decrease nurses’ workload and enhance efficiency. The primary outcome is paJents’ Barthel Index (acJviJes of daily living: mobility, self-­‐care and toileJng) at 6 months. Process and economic evaluaJon will also be conducted. The results of our study will generate high-­‐quality evidence to improve stroke care in resource-­‐scarce sedngs. If proven effecJve, it has a significant potenJal to guide policy-­‐making and advance translaJonal research in the field of stroke care, improve the health and funcJon of stroke paJents, relieve caregiver burden, build capacity and “task-­‐shi\ing” within the health care delivery system. Randomiza3on I IntervenJon arm: Caregiver-­‐delivered nurse-­‐
organized rehabilitaJon (n=100) 6-­‐month telephone follow up (BI, FAC, mRS, EQ-­‐5D,PHQ-­‐9,CBI) BI: Barthel Index, measuring the acJviJes of daily living with ten quesJons in three domains: mobility, self-­‐care and conJnence/toileJng ; mRS: Modified Rankin Scale, evaluaJng paJents’ disability stage; PHQ: PaJent health quesJonnaire, measuring paJents’ common mental disorders; FAC: FuncJonal AmbulaJon ClassificaJon, measuring the stage of paJents’ ambulaJon ability; EQ-­‐5D: Measuring quality of life ; CBI: Caregiver burden index, measuring caregiver’s burden in caring for paJents Therapists train nurses RECOVER Model Discussion Caregivers delivered rehabilitaJon services to paJents Trained nurses train family caregivers