Effectiveness of a CDSS and Internet of Things-based comprehensive hypertension management system in primary health care settings: study protocol for the CATCH Trial

BACKGROUND: Cardiovascular and cerebrovascular diseases are the leading causes of death in the Chinese population, and hypertension is one of the key risk factors. However, the blood pressure control rate of hypertensive patients is low at present. The main factors include the limited capacity of primary care workers and poor self-management among hypertensives. The purpose of this program is to use a clinical decision support system (CDSS) and an Internet of Things-based comprehensive hypertension management system (CATCH) to provide decision support for the diagnosis and treatment of hypertension for primary care clinicians and to improve the standardisation of the diagnosis, monitoring, treatment, and continuous management of hypertension among them. METHODS: This study is a stepped wedge cluster randomised controlled trial conducted in 12 community health centres in the Third People's Hospital of Longgang District, Shenzhen City, China. All participants who are registered in the community and with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg at the screening clinic will be asked to participate in the study. The intervention is a CATCH composite of a hypertension auxiliary decision-making module, clinical diagnosis and treatment knowledge education system, and quality control system. All 12 clusters will be divided into 4 clusters and 5 stages according to a randomised method, with each stage lasting 3 months, ensuring that the entire trial will be completed within 12 months. DISCUSSION: The CATCH trial uses CDSS and IoT to improve hypertension management in primary care. This stepped wedge trial enhances guideline adherence and patient outcomes through remote monitoring and quality control. All centres receive the intervention, ensuring equitable access to it. Results will guide future hypertension strategies. TRIAL REGISTRATION: The trial was registered at the National Medical Research Registration and Record Filing Information System of China in December 2024, was retrospectively registered at the Chinese Clinical Trial Registry (ChiCTR) (Registration number: ChiCTR2500098845) https://www.chictr.org.cn/.