Rehabilitation for Disabled Stroke Patients in Rural China
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): Patients recruited into the intervention arm will have their family-nominated caregivers trained by a trained nurse and guided by a culturally appropriate and easy-to-understand rehabilitation manual to be given to caregivers at the last session, shortly before hospital discharge to reduce contamination. The training sessions will take at least 90 minutes per day for 2 or 3 days.The nurse will call the patients and caregivers at 2, 4, and 8 weeks after hospital discharge to monitor progress and offer guidance on rehabilitation.Duration of the standardized yet individualized intervention by nurses will be 8 weeks; however, trained caregivers are expected to deliver the rehabilitation services to patients as long as they are needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: caregiver delivered rehabilitation; nurse-organized service; disabled stroke patients