Clinical Trials Logo
NCT number NCT03185858
Study type Interventional
Source Duke Kunshan University
Contact Wanbing Gu, Msc.
Phone (+86) 0512 36657242
Status Not yet recruiting
Phase N/A
Start date June 2017
Completion date December 2018

Clinical Trial Summary

The aim of the study is to evaluate the effectiveness the SINEMA model via a one-year cluster randomized controlled trial in a resource-poor rural area in China. The hypothesis is that trained village doctors (VDs) and family caregivers, equipped with digital health technology, can provide essential evidence-based care to stroke survivors in rural China.

Clinical Trial Description


Stroke imposes major societal and economic burdens and is one of the leading causes of death and disability in rural China. Stroke survivors suffer from high risk of recurrence with particularly high rates reported for China, signifying the importance of secondary prevention of stroke. Although improving the quality of stroke care has become a national priority since 2009, post-acute secondary prevention and rehabilitation are largely unavailable in rural China and where present are far below evidence-based standard.

SINEMA model

We propose a system-integrated technology-enabled model of care (SINEMA) model. The model, cognizant of health system's organization around tertiary, secondary, and primary levels in China, adopts the principles of cascade training with feedback and task-sharing, and relies on existing human resources available at the community level. It also proposes the use of innovative mobile technology as tools (Android-based smartphone application for VDs and text/voice messages for patients), with the overarching aim of providing evidence-based and essential patient management focusing on medication adherence and physical activity.

Study design

The SINEMA model will be implemented in Nanhe County, China and be evaluated through a cluster-randomized control trial. Fifty villages with about 25 stroke patients per village will be recruited. After a baseline survey, these villages will be randomized in a 1:1 ratio to either the intervention group (SINEMA model) or the control group (usual care). Follow-up survey will be conducted in the same way in all villages at 3-month and 12-month after the initial of the study. The primary outcome is systolic blood pressure and a number of secondary and exploratory outcomes will be collected. Process evaluation and economic evaluation will also be conducted.

Study Design

Related Conditions & MeSH terms

See also
  Status Clinical Trial Phase
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT02822144 - General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke Phase 3
Recruiting NCT02513589 - Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke Phase 2
Not yet recruiting NCT03177954 - Developing a Patient Oriented Discharge Summary for Stroke Inpatients N/A
Recruiting NCT02960009 - Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke N/A
Recruiting NCT02906956 - Music and Adherence Home Programs Post Stroke Phase 0
Recruiting NCT02889562 - Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation Phase 2/Phase 3
Recruiting NCT03183635 - Rapid Movement Therapy for Stroke Rehabilitation N/A
Recruiting NCT03080454 - The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke N/A
Recruiting NCT02828306 - Computer Based Algorithm for Patient Specific Implants for Cranioplasty in Patients With Skull Defects N/A
Recruiting NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction N/A
Recruiting NCT02916030 - Vitamin D and Stroke N/A
Active, not recruiting NCT02753257 - Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation N/A
Enrolling by invitation NCT02898558 - Effect of Body Representation in Movement N/A
Completed NCT03025776 - One vs. Two Hand Use After Stroke: Role of Task Requirements Phase 0
Completed NCT03053154 - Relationship Between Pelvic Tilt and Sit to Stand Task in Stroke Patients N/A
Completed NCT02868996 - An Open Label, Phase 1b, Ascending Dose Study of DM199 Phase 1
Recruiting NCT02625948 - Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign Phase 2
Recruiting NCT02565199 - Premotor Cortex: A New Target for Stroke Motor Rehabilitation N/A