A randomized controlled trial on rehabilitation through caregiver-delivered nurse-organized service programs for disabled stroke patients in rural China (The RECOVER trial)
Stroke is the second leading cause of mortality and the leading cause of disability among adults worldwide. Rehabilitation is an effective treatment for stroke; however rehabilitation services are nearly non-existent in rural areas, especially in China. Here, we propose to develop, implement, and evaluate an evidence-based caregiver-delivered "Early Supported Discharge (ESD)" stroke rehabilitation program designed to improve the physical functioning of disabled stroke patients in rural China.
The study will be conducted in four phases:
1. study preparation
2. pilot study
3. study revision
4. main study
The pilot study will test the feasibility of the program in one county hospital among 60 patients for 3 months. The main study will test the program in two county hospitals (one in Zhangwu County, Liaoning and one in Qingtongxia County, Ningxia) among 200 patients for one year. Eligible patients (stroke inpatients with residual disability) will be randomized to the intervention group (ESD program) or control group (usual care) within 7 days of hospital admission. Patients in the intervention group will receive stroke care from a family-nominated caregiver, who will be trained in ESD by a specially trained nurse and guided by a rehabilitation manual. In the main study, a nurse will monitor patient progress and care up to 6 times. Baseline assessments of physical functioning (Barthel Index, Functional Ambulation Category), quality of life (EQ-5D), and caregiver burden (Caregiver Burden Index) will be assessed for all patients before discharge, with follow-up assessments at 3 months in the pilot study and 3, 6, and 12 months in the main study.
This study, if proven effective, will seek to improve the health and functioning of stroke patients, relieve caregiver burden, build capacity and task-shift within the care-delivery system, and potentially guide future programs and policies that can improve health outcomes and reduce inequities for stroke patients in resource-scarce settings.