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Background and Purpose—Stroke disability is a major health burden in rural China where rehabilitation services are
inadequate. We aimed to determine the effectiveness of a novel nurse-led, caregiver-delivered model of stroke rehabilitation
in rural China.
Methods—A multicenter prospective, randomized open, blinded outcome assessed, controlled trial was conducted in 3 rural
county hospitals in China: Zhangwu, Liaoning Province (Northeast); Qingtongxia, Ningxia Hui Autonomous Region
(Northwest); and Dianjiang, Chongqing Municipality (Southwest). Adult patients (age 18–79 years) with residual
disability (Barthel Index score ≤80/100) after a recent acute stroke were randomized to a new service model or usual
care. The new intervention was multifaceted and was based on a task-shifting / training-the-trainers model, supported by
a custom-designed smartphone application, where patients and caregivers received evidence-based in-hospital education
and stroke rehabilitation training (focus on mobility, self-care, and toileting), delivered by trained nurses before hospital
discharge, and 3 postdischarge support telephone calls. Outcome assessments were undertaken before hospital discharge
and at 3 and 6 months. Primary outcome was physical functioning (Barthel Index scores) at 6 months, assessed by
research staff blind to treatment allocation, adjusted for baseline covariates in an intention-to-treat analysis. Secondary
outcomes included measures of mobility, health-related quality of life, mood, and caregiver burden. The study included a
process evaluation that assessed intervention fidelity.
Results—From November 2014 to December 2016, 246 stroke patients were randomized to intervention (n=118) or control
Downloaded from http://ahajournals.org by on June 21, 2023
(n=128) groups. There was no statistically significant difference in adjusted 6-month Barthel Index scores between groups
(70.1 versus 74.1, mean difference, −4.0 [95% CI, −10.0 to 2.9]), nor any differences across the other outcome measures.
Process evaluation interviews revealed that the intervention was desirable and positively accepted by nurses, caregivers,
and patients but was considered too complex despite efforts to simplify materials for the rural context. Key strategies
identified for future studies included the use of community health workers, smartphone application enhancement, and
simpler and more frequent training for nurses, caregivers, and patients.
Conclusions—A novel nurse-led, digital supported, caregiver-delivered stroke rehabilitation program did not improve
patient physical functioning after stroke in rural China. Further stroke rehabilitation research suitable for resource-poor
settings is required, with several components being suggested through stakeholder interviews in our study.
Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT02247921. (Stroke.
2019;50:1825-1830. DOI: 10.1161/STROKEAHA.118.021558.)
Key Words: caregivers ◼ China ◼ nurses ◼ rehabilitation ◼ stroke
Received March 23, 2018; final revision received April 7, 2019; accepted April 15, 2019.
From the Department of Clinical Epidemiology, First Hospital of China Medical University, Shenyang (B.Z., Q.Z., J.S.); The George Institute
for Global Health at Peking University Health Science Center, Beijing, China (J.Z., Xian Li, C.S.A., R.L., Y.W., L.L.Y.); School of Public Health
and Management, Ningxia Medical University, Yinchuan, China (Y. Zhao, Y. Zhang, Xiaoxia Li); The George Institute for Global Health, Faculty
of Medicine, UNSW, Sydney, Australia (Xian Li, C.S.A.); Department of Rehabilitation Medicine, Peking University First Hospital, Beijing, China
(B.X., N.W.); School of Public Health and Management, Chongqing Medical University, China (X.T., Z.S.); Duke Clinical Research Institutea (J.P.B.)
and Duke Global Health Institute (J.P.B., L.L.Y.), Duke University, Durham, NC; Global Health Research Center, Duke Kunshan University, China
(S.C., W.G., L.L.Y.); Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Australia (R.I.L.); Oxford Clinical Trials
Research Unit, University of Oxford, United Kingdom (S.E.L.); Peking University Clinical Research Institute, Beijing, China (Y.W.); and School of
Public Health, Peking University Health Science Center, Beijing, China (Y.W.).
*Drs Zhou and J. Zhang are cofirst authors.
The online-only Data Supplement is available with this article at https://www.ahajournals.org/doi/suppl/10.1161/STROKEAHA.118.021558.
Correspondence to Jingpu Shi, PhD, First Hospital of China Medical University, No. 115 Nanjing St, Heping District, Shenyang, Liaoning, China, Email
sjp562013@163.com or Lijing L. Yan, PhD, Global Health Research Center, Duke Kunshan University, No. 8 Duke Ave, Kunshan, Jiangsu Province,
China, Email lijing.yan@dukekunshan.edu.cn
© 2019 The Authors. Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article
under the terms of the Creative Commons Attribution Non-Commercial License, which permits use, distribution, and reproduction in any medium, provided
that the original work is properly cited and is not used for commercial purposes.
Stroke is available at https://www.ahajournals.org/journal/str DOI: 10.1161/STROKEAHA.118.021558
1825
1826 Stroke July 2019
Delivered Nurse-Organized Service Programs for Disabled The primary outcome was ADL defined by scores on the BI at 6
Stroke Patients in Rural China). months postrandomization, assessed in-person by trained research
nurses who were blind to the treatment assignment. Secondary
outcomes included BI scores at predischarge and 3-month postran-
Methods domization; modified Rankin Scale scores16 at the 3 and 6 months;
Data from this study are available from the corresponding author on scores on the Functional Ambulation Category,17 Patient Health
reasonable request. Questionnaire 9,18 and EuroQol-5-dimension19 at 6 months; and a
measure of Caregiver Burden Index20 at 6 months. Other information
collected included hospital length of stay and medical costs obtained
Design from questionnaires completed by participants and all adverse events
Full details of the study protocol for the RECOVER trial have been including rehospitalization and death, with details recorded by nurses
published.11 In brief, the study was conducted at 3 county hospitals reported to the study coordinating center.
in rural China: Zhangwu, Liaoning Province (Northeastern China);
Qingtongxia, Ningxia Hui People Autonomous Region (Northwestern
China); and Dianjiang, Chongqing municipality (Southwestern Process Evaluation
China). Hospitalized patients with a clinical diagnosis of acute stroke A process evaluation assessing fidelity to the intervention, involved
(ischemic, hemorrhagic, or undifferentiated) considered suitable for standardized, semistructured interviews (20–40 minutes) with nurses
rehabilitation by their attending physician were eligible for the study who delivered the rehabilitation model of care and 2 patient/caregiver
if they were aged 18 to 79 years, required assistance with ADL (score pairs at each site, was undertaken during site monitoring visits at 3
≤80/100 on the Barthel Index [BI]12) but without severe disability, and 9 months. Participatory observation of the intervention and focus
were free of serious comorbid diseases and with an estimated life ex- groups with nurses, which lasted ≈60 minutes, were also conducted.
pectancy >6 months, and able to provide consent. Details of sociode- All interviews were voice-recorded with consent, and the transcripts
mographic characteristics, medical history, and ADL were collected analyzed by independent researchers using a thematic framework21
at baseline. Patients were randomized via a secure, central internet- for coding and descriptions of opinions.
based system, with randomly variable block sizes (4, 6, and 8) strati-
fied by ADL status (BI scores ≤40 versus 40–80) either to intervention
(nurse-organized, family caregiver delivered) rehabilitation or control Statistical Analysis
(usual) care. An integrated Android-based application was installed Based on studies indicating considerable variability in BI scores
on nurses’ smartphones (Red Mi Note 4G, Xiao Mi, Inc) to allow among stroke survivors, with SD ranging 10 to 3022,23 and scores for
integrated data collection, randomization, quality control, and oper- improvement of 10 to 35 points,24 we estimated that a sample size
ational guide, with data security ensured by hash algorithm (Secure of 86 patients per group would provide 90% power (2-sided α of
Hash Algorithm 512 [SHA512]) and secure socket layer (Hypertext 0.05) to detect a 10-point difference in BI scores between groups.
Transfer Protocol Secure [HTTPS]). The study was approved by the Assuming a SD of 20, this between-group difference corresponds to
ethics committees of the China Medical University, Ningxia Medical a standardized effect size of 0.50. However, taking account of 10%
University, Chongqing Medical University, and Duke University, and missing primary outcome, the target sample was 200 patients (100
all patients provided informed consent. per group).
Zhou et al Stroke Rehabilitation in Rural China 1827
by site. All analysis was conducted using SAS 9.4 software (SAS Cardiovascular disease, n (%) 27 (23.3) 26 (20.3) 53 (21.7)
Institute, Inc, Cary, NC).
Caregivers
Table 2. Effectiveness of Intervention at 6-Month Target Date After did not improve ADL function after stroke. Our trial differed
Rehabilitation Services Based on Intention-to-Treat Analysis (Multiple Linear
Regression)
from these studies in several aspects but most notably in
regards to the approach to training and support which was free
Outcomes Intervention Control P Value* of direct input from rehabilitation physicians and therapists;
Primary rather, nurses were trained to deliver rehabilitation to patients/
caregivers in hospital and at home.
BI (N=233) at 6 mo 70.1 (25.5) 74.1 (23.0) 0.27
Our imbedded process evaluation showed that the stroke
Secondary rehabilitation program was well implemented by the nurses
FAC (N=233) at 6 mo 4.6 (1.7) 5.0 (1.4) 0.04 (dose delivered), and nearly all caregivers and patients received
mRS scores 0–1 79 (32.1) 88 (35.8) 0.21 training in hospital and at home (dose received). Even so, the
(N=233) at 6 mo† qualitative interviews disclosed several negative responses,
highlighting challenges in delivering this model of care which
PHQ-9 (N=230) at 6 mo 5.5 (5.5) 5.0 (4.9) 0.44
affected fidelity of the intervention. Despite our efforts to en-
EQ-5D (N=226) at 6 mo 0.7 (0.3) 0.8 (0.3) 0.15 sure that the training could be integrated into routine care, the
Exploratory trainer nurses expressed concern over an increase in workload
CBI (N=231) at 6 mo 73.0 (23.1) 74.5 (19.6) 0.56 and that their other duties assumed priority over those associated
with the intervention. Although increased in-hospital rehabilita-
Total expenses in 2861.4 (4205.7) 2765.8 (3780.9) 0.84
tion may assist patients, it may not be feasible in a task-shifting
hospital (N=238), CNY
model without freeing up nursing time from other tasks. Another
Average length of 14 (11–17) 14 (10–16) 0.35 concern of nurses was inconsistency in the delivery of care by
hospital stay, d‡
caregivers, whereas patients expressed reluctance to exercise
(N=238), median (IQR)
without appropriate supervision, which led to the level of partici-
Data are n (%), mean (SD) or median (IQR). BI indicates Barthel Index; CBI, pation of patients in exercises fell off upon their discharge home.
Caregiver Burden Index; CNY, Chinese Yuan; CVD, cardiovascular disease; EQ-
5D, EuroQol-5-dimension; FAC, Functional Ambulation Category; mRS, modified
Thus, future task-shifting models of care need to ensure there
Rankin Scale; and PHQ-9 Patient Health Questionnaire 9. are sufficient human resources (ie, nurses and caregivers), with
*Adjusting different hospitals, baseline BI, age, sex, education level, stroke the potential to integrate a trained community health worker, to
type, no. of previous strokes, hypertension, CVD, and diabetes mellitus. facilitate the development of skills by patients at home.
†χ2 test. Another potential limitation of our study was that the nurses
‡Wilcoxon test, median (Q1, Q3). were insufficiently skilled to deliver an appropriate standard of
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Figure 3. Average Barthel Index (BI) scores for intervention and control groups with stroke in rural China by predefined subgroups.
Downloaded from http://ahajournals.org by on June 21, 2023
settings, in particular for task-shifting and training-the-train- care, though desired and well-accepted by stakeholders, did
ers approaches being successfully adapted to rural China. The not produce significant improvements over usual care in the
study team’s evidence-based rehabilitation training with pic- recovery of ADL among participants in rural China. In this
ture-rich manuals for both nurses and patients/family caregiv- foundational study, future directions for research have been
ers was acceptable to all parties and achieved clear, practical highlighted that include the utilization of community health-
benefits across the intervention program. In this context, sev- care workers, enhancement of smartphone applications for
eral important future research directions were defined: training communication, education and data collection, and review
time and intensity reconfigurations, training manual develop- of the appropriate format and duration of training. More
ment, community healthcare worker uptake, and smartphone efforts and different models are required to develop effective
application enhancement. approaches to improve recovery from stroke in low-resource
In summary, our evaluation of task-shifting stroke reha- setting of China and other countries.
bilitation by nurses who trained family caregivers to provide
Acknowledgments
Table 3. Adherence to Intervention Protocol in the Intervention Group R. Luo and J. Zhang searched the literature; Drs Xie, Wang, Y. Zhang,
Prvu Bettger, Lindley, Anderson, Lamb, Wu, Shi, and Yan were re-
Zhangwu Qingtongxia Dianjing sponsible for study design; Dr Xie and Wang developed the inter-
County County County Total vention protocol; Q. Zhao, X. Li, and Z. Sun collected data; XL, J.
N=31 N=54 N=29 N=114 Zhang, and Dr Yan analyzed and interpreted the data; Drs Zhou, Y.
Zhang, Shi, YZ, and X. Tang were responsible for project implemen-
No. of completed training sessions in hospital tation; J. Zhang, Drs Zhou, YZ, Chen, and W. Gu undertook project
management; Q. Zhao, X. Li, Z. Sun, J. Zhang, Drs Zhou, YZ, X.
≥3× 26 (83.9) 47 (87.0) 26 (89.7) 99 (86.8)
Tang, and Yan were responsible for quality control; and J. Zhang and
Total duration of training session in hospital Dr Zhou wrote the first draft of the article. All authors made crit-
ical revisions of the article. We thank all directors, nurses, patients,
≥1 h, n (%) 27 (81.7) 51 (94.4) 27 (93.1) 105 (92.1) and caregivers of participating hospitals for their cooperation in the
Training time in 2.3 (1.2) 1.7 (0.7) 1.9 (0.7) 1.9 (0.9) study and Yu Liu of Beihang University for developing the smart-
hospital, h phone application.
the Netherlands and additional funding from The George Institute 10. Ogedegbe G, Gyamfi J, Plange-Rhule J, Surkis A, Rosenthal DM,
China and Duke Kunshan University. None of these organizations Airhihenbuwa C, et al. Task shifting interventions for cardiovascular risk
had any role in writing of the article or the decision to submit it for reduction in low-income and middle-income countries: a systematic re-
publication. The corresponding authors had full access to all the data view of randomised controlled trials. BMJ Open. 2014;4:e005983. doi:
in the study and final responsibility for the decision to submit for 10.1136/bmjopen-2014-005983
publication. 11. Yan LL, Chen S, Zhou B, Zhang J, Xie B, Luo R, et al. A randomized
controlled trial on rehabilitation through caregiver-delivered nurse-orga-
nized service programs for disabled stroke patients in rural china (the
Disclosures RECOVER trial): design and rationale. Int J Stroke. 2016;11:823–830.
doi: 10.1177/1747493016654290
There is no support from any organizations for the submitted work.
12. Mahoney FI, Barthel DW. Functional evaluation: the barthel index. Md
No financial relationships with any organizations that might have an
State Med J. 1965;14:61–65.
interest in the submitted work in the previous 3 years. Dr Anderson 13. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et
reports receiving Advisory Board fees from Amgen and Boehringer al. Better reporting of interventions: template for intervention description
Ingelheim and grants and speaker fees and travel reimbursement from and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.
Takeda. No other relationships or activities that could appear to have doi: 10.1136/bmj.g1687
influenced the submitted work. The other authors report no conflicts. 14. Sulter G, Steen C, De Keyser J. Use of the Barthel index and modified
Rankin scale in acute stroke trials. Stroke. 1999;30:1538–1541.
15. Kwon S, Hartzema AG, Duncan PW, Min-Lai S. Disability meas-
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