Clinical trial NCT02247921: Rehabilitation for Disabled Stroke Patients in Rural China
Official title: A Randomized Controlled Trial on Rehabilitation Through Caregiver-delivered Nurse-organized Service Programs for Disabled Stroke Patients in Rural China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: caregiver delivered rehabilitation
nurse-organized service
disabled stroke patients
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Stroke is the second leading cause of mortality and disability among adults worldwide. Rehabilitation is an effective treatment for stroke; however rehabilitation services are far from adequate in China, especially in rural areas where the health and economic burden of disability from stroke is very high.

The investigators propose to develop, implement, and evaluate an evidence-based caregiver-delivered stroke rehabilitation program designed to improve the physical functioning of disabled stroke patients in rural China.

Detailed description: This randomized controlled trial will be conducted in Zhangwu People's Hospital in Liaoning Province, Qingtongxia People's Hospital in Ningxia Hui Autonomous Region and Dianjiang People's Hospital in Chongqing City. Eligible and consenting stroke in patients with residual disability will be randomized into the intervention group or control group after they have passed the acute care stage and approved by their physicians to be recruited into the study. Standardized baseline assessments for all patients include Barthel Index (activities of daily living), modified Rankin Scale, and other demographic, disease history, lifestyle, and health information. Nurses in the county hospital will be trained by rehabilitation specialists and will in turn train the family caregivers of patients in the intervention group with the aid of an easy-to-understand picture-rich rehabilitation manual, specially designed for this study. The content of training is based on 10 domains in the Barthel Index, which can be classified into 3 groups: mobility, self-care, and toileting. Nurses will do the telephone based follow-up to patients at approximately 2, 4, and 8 weeks post-discharge to provide follow-up care and consultation. Follow-up evaluation of all patients will be conducted by researchers not involved in the intervention. Pre-discharge evaluation including Barthel Index, modified Rankin Scale and Functional Ambulation Category will be conducted face to face with patients, . 3 months and 6 months evaluation will be conducted via telephone based interview.3 months evaluation includes living condition, Barthel Index ,modified Rankin Scale, hospitalization condition and medicine usage. Based on 3 months evaluation, 6 months evaluation includes additional measures: Functional Ambulation Classification, EQ-5D, 9-item Patient Health Questionnaire, physical examination and caregiver burden. Primary outcome will be the Barthel Index score at 6-month after hospital discharge. The study will be conducted in 2 phases: 1) pilot study (Lasting for 2 months, 30 patients in Zhangwu People's Hospital and 30 patients in Qingtongxia People's hospital); and 2) main study (Lasting for 15 months, 100 patients in Zhangwu People's Hospital, 100 patients in Qingtongxia People's hospital and 60 patients in Dianjiang People's Hospital). Information from pilot study will be used for refinement of the intervention and study implementation. Patients in the pilot study will be followed until the end of the study, resulting in a total of 320 patients.

Primary Hypothesis: The innovative caregiver-delivered nurse-organized rehabilitation intervention, compared to usual care, will significantly improve physical functioning of disabled stroke patients in rural China, as measured by the Barthel Index (activities of daily living) at six months after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years，and≤79 years);
* Recent (\<1 month) first-ever acute ischemic/hemorrhagic/undifferentiated stroke patients;or recurrent patients with the result of Modified Rankin Scale (MRS) no more than 2 points.
* With a reasonable expectation of 6 month survival post-discharge (i.e. not palliative, no evidence of widespread cancer etc.);
* Residual disability (requiring physical assistance for core activities of daily living defined as a Barthel Index score of 80 or lower)

Exclusion Criteria:

* Unable to identify a suitable family-nominated caregiver for training and subsequent delivery of care
* Unable to provide informed consent from both the patient (or by proxy) and the caregiver

Primary outcomes:
measure: Barthel Index (activities of daily living) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Barthel Index at 3 months
timeFrame: 3 months
measure: Functional Ambulation Classification (FAC) at 6 months
timeFrame: 6 months
measure: EQ-5D quality of life at 6 months
timeFrame: 6 months
measure: Patient Health Questionnaire - 9 items at 6 months
timeFrame: 6 months
measure: Modified Rankin Scale at 3 and 6 months
timeFrame: 3 and 6 months
Other outcomes:
measure: Caregiver Burden Index at 6 months
timeFrame: 6 months
measure: hospitalization
timeFrame: 6 months
measure: medical costs
timeFrame: 6 months
Locations:
city: Beijing
country: China
facility: The Georgeinstitute of Global Health at Peking University Health Science Center
state: Beijing
Study officials:
affiliation: Duke Kunshan University
name: Lijing Yan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou B, Zhang J, Zhao Y, Li X, Anderson CS, Xie B, Wang N, Zhang Y, Tang X, Prvu Bettger J, Chen S, Gu W, Luo R, Zhao Q, Li X, Sun Z, Lindley RI, Lamb SE, Wu Y, Shi J, Yan LL. Caregiver-Delivered Stroke Rehabilitation in Rural China. Stroke. 2019 Jul;50(7):1825-1830. doi: 10.1161/STROKEAHA.118.021558. Epub 2019 Jun 10.