Study on self-management of real-time and individualized support in stroke patients based on resilience: a protocol for a randomized controlled trial.

BACKGROUND

The transitional period from hospital to home is vital for stroke patients, but it poses serious challenges. Good self-management ability can optimize disease outcomes. However, stroke patients in China have a low level of self-management ability during the transitional period, and a lack of effective support may be the reason. With the rapid development of technology, using wearable monitors to achieve real-time and individualized support may be the key to solving this problem. This study uses a randomized controlled trial design to assess the efficacy of using wearable technology to realize real-time and individualized self-management support in stroke patients' self-management behavior during the transitional period following discharge from hospital.

METHODS

This parallel-group randomized controlled trial will be conducted in two hospitals and patients' homes. A total of 183 adult stroke patients will be enrolled in the study and randomly assigned to three groups in a 1:1:1 ratio. The smartwatch intervention group (n = 61) will receive Real-time and Individualized Self-management Support (RISS) program + routine care, the wristband group (n = 61) will wear a fitness tracker (self-monitoring) + routine care, and the control group (n = 61) will receive routine stroke care. The intervention will last for 6 months. The primary outcomes are neurological function status, self-management behavior, quality of life, biochemical indicators, recurrence rate, and unplanned readmission rate. Secondary outcomes are resilience, patient activation, psychological status, and caregiver assessments. The analysis is intention-to-treat. The intervention effect will be evaluated at baseline (T0), 2 months after discharge (T1), 3 months after discharge (T2), and 6 months after discharge (T3).

DISCUSSION

The cloud platform designed in this study not only has the function of real-time recording but also can push timely solutions when patients have abnormal conditions, as well as early warnings or alarms. This study could also potentially help patients develop good self-management habits through resilience theory, wearable devices, and individualized problem-solution library of self-management which can lay the foundation for long-term maintenance and continuous improvement of good self-management behavior in the future.

TRIAL REGISTRATION

The ethics approval has been granted by the Ethics Committee of West China Hospital, Sichuan University (2022-941). All patients will be informed of the study details and sign a written informed consent form before enrollment. The research results will be reported in conferences and peer-reviewed publications. The trial registration number is ChiCTR2300070384 . Registered on 11 April 2023.