Whole-course care intervention for patients with spinal cord injury: study protocol for a randomized controlled trial

Spinal cord injury (SCI) leads to serious damage to body structure and function and is accompanied by high rates of disability and complications, significantly reducing quality of life and causing substantial family and social burdens. Owing to the complexity of the disease process and the limitations of physical activity, patients with SCI have dynamic and multidimensional care needs in different stages, such as the acute stage, recovery stage, and chronic stage. However, the existing interventions focus mostly on a single stage of the disease course or isolated functional symptoms and lack responses to the changing needs of individuals throughout the whole disease course. Therefore, this study will evaluate the effects of a whole-course care program on patients with SCI. This study is a single-blind, two-group randomized controlled trial that includes 80 patients with SCI from one tertiary grade A general hospital. The control group will undergo routine departmental intervention, while the intervention group will receive comprehensive care intervention throughout the disease process, providing corresponding intervention measures during the acute phase, early recovery phase, mid-recovery phase, and chronic phase of patients with SCI. The primary outcome indicator is quality of life. We plan to designate the 12th month after admission (after the end of the intervention) as the primary time point for assessing quality of life. The WHOQOL-BREF will be used to calculate the scores of patients with spinal cord injury in the physical, psychological, social relationships, and environment domains. the secondary outcome indicators are functional independence, self-efficacy, activity participation, social support, and severity of depression. All outcome indicators will be evaluated at the time of admission (baseline), 4th week after admission, 3rd month after admission, 6th month after admission, and 12th month after admission. If the intervention is effective, it may significantly improve the health-related quality of life, functional independence, self-efficacy, social participation, and severity of depression of patients with SCI. ChiCTR2400084885. Registered on 27 May 2024.