Collaborative Care Model Based Telerehabilitation Exercise Training Program for Acute Stroke Patients in China: A Randomized Controlled Trial

Introduction: Early supported discharge (ESD) is a transitional care model aimed at facilitating post-acute stroke patients' discharge to home. Previous studies have demonstrated that ESD provides equivalent patient and caregiver outcomes with superior cost-effectiveness compared to conventional rehabilitation (CR). This study intends to examine the feasibility of ESD in Korea.Methods and Analysis: This study is designed as a multicenter assessor-blinded, randomized controlled trial. Ninety post-acute stroke patients with mild to moderate disability (modified Rankin Scale 1–3) will be recruited from three university hospitals (30 patients per hospital) in Korea and allocated to either the ESD group or the CR group in a 1:1 ratio. Patients in the ESD group will receive individualized discharge planning and goal setting, a 4-week home-based rehabilitation program, and liaison service to community-based resources by a multidisciplinary team. Patients in the CR group will receive rehabilitation practices according to their current hospital policy.Outcomes: The primary outcome is the Korean version of the modified Barthel Index, and the primary endpoint was post-onset 3 months. Clinical outcomes, patient/caregiver reported outcomes, and socioeconomic outcomes will be measured at baseline, 1 month after discharge, 2 months after discharge, and 3 months after onset.Discussion: The efficacy and cost-effectiveness of ESD can vary according to the healthcare system and sociocultural aspects. To establish ESD as an alternative transitional care model for post-acute stroke patients in Korea, its feasibility needs to be examined in prior. This study will add evidence on the applicability of ESD in Korea.Ethical Considerations: The study protocol was reviewed and approved by the Institutional Review Board of Seoul National University Bundang Hospital (IRB number B-2012/654-308). The study protocol was registered at ClinicalTrials.gov (Identifier NCT04720820). Disseminations will include submission to peer-reviewed journals and presentations at conferences.

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Wake-Promoting Effect of Bloodletting Puncture at Hand Twelve Jing-Well Points in Acute Stroke Patients: A Multi-center Randomized Controlled Trial

Chinese Journal of Integrative Medicine ◽

10.1007/s11655-020-3093-8 ◽

2020 ◽

Author(s):

Nan-nan Yu ◽

Zhi-fang Xu ◽

Yang Gao ◽

Zhi-liang Zhou ◽

Xue Zhao ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Acute Stroke ◽

Controlled Trial ◽

Stroke Patients ◽

Promoting Effect ◽

Randomized Controlled

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Individualized nutritional treatment for acute stroke patients with malnutrition risk improves functional independence measurement: A randomized controlled trial

Geriatrics and Gerontology International ◽

10.1111/ggi.13854 ◽

2019 ◽

Vol 20 (3) ◽

pp. 176-182 ◽

Cited By ~ 3

Author(s):

Ikuto Otsuki ◽

Nobuaki Himuro ◽

Hiroomi Tatsumi ◽

Mitsuru Mori ◽

Yoshimasa Niiya ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Acute Stroke ◽

Controlled Trial ◽

Functional Independence ◽

Stroke Patients ◽

Nutritional Treatment ◽

Randomized Controlled ◽

Functional Independence Measurement

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Abstract NS4: Challenges and Lessons Learned in an Ongoing Randomized Controlled Trial to Test the Effectiveness of a Multicomponent Intervention in Improving Delirium Outcomes in Acute Stroke

Stroke ◽

10.1161/str.46.suppl_1.ns4 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Karen L Rice ◽

Marsha Bennett ◽

Linley Berger ◽

Bethany Jennings ◽

Erin Barry ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Acute Stroke ◽

Controlled Trial ◽

Lessons Learned ◽

Intervention Fidelity ◽

Stroke Patients ◽

Randomized Controlled ◽

Multicomponent Intervention ◽

Study Staff ◽

Therapeutic Activities

Delirium in acute stroke has higher morbidity and mortality than those without delirium. This two-group randomized controlled trial (RCT) tests if a multicomponent intervention improves delirium outcomes in stroke patients at a comprehensive stroke center. This presentation describes the challenges in managing a RCT in acute stroke. Scientific rigor requires coordinating staff, enrolling adequate sample size, assuring intervention fidelity, and fostering data integrity. A sample of 282 subjects is required for 80% power (α=0.05) to determine a 10% reduction in incident delirium. Eligibility includes acute stroke, aged ≥ 50 years, no aphasia or delirium on admit. Subjects randomized to Usual Care (UC) or Delirium Care (DC). Both groups receive standardized Stroke Care. DC subjects receive a multicomponent intervention: 1) pharmacist recommendations using Anticholinergic Drug scale scores; and 2) therapeutic activities. NIHSS, Montreal Cognitive Assessment (MoCA), Confusion Assessment Method (CAM), and mRS are used to determine primary (delirium) and secondary endpoints (LOS, neurological deficit, functional status). A total of 513 patients screened over 289 consecutive days required unbudgeted staff. The 310 excluded [aphasia (94), baseline delirium (36), critically ill (92), LOS <2 days (69), other causes (19)] unexpectedly impacted enrollment. Of eligible, 66% (133/203) consented; UC (n=65), DC (n=68). Hospital volunteers engaged DC subjects in therapeutic activities twice daily, including holidays. Two pharmacists independently made recommendations for each group. Outcome data were validated at daily rounds. Stroke-related cognitive dysfunction required more time than norm to complete the MoCA. Both the CAM and team consensus was used to confirm delirium. Lessons learned: 1) study staff attending rounds was key to enrollment, intervention fidelity, and data integrity; 2) securing a pool of on-call volunteers to sustain therapeutic activities was required; and 3) additional and unanticipated resources were needed. In conclusion, successful conduct of a RCT in acute stroke patients requires a dedicated well-trained study staff 7 days a week, including holidays.

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