Adaptive intervention to improve self-management behaviours among hypertensive patients in rural primary care settings: protocol for a Sequential Multiple Assignment Randomised Trial (SMART).

backgroundHypertension remains a major public health challenge in rural China, where blood pressure control rates remain low, primarily due to inadequate self-management behaviours among patients. While physician-patient interaction plays a critical role in shaping self-management behaviours, few interventions leveraging this mechanism-particularly those tailored to individual behavioural trajectories-have been implemented in rural primary care. This study aims to design and evaluate the effectiveness of an adaptive, interaction intervention to improve self-management behaviours among patients with hypertension in rural China.

methodsA Sequential Multiple Assignment Randomised Trial (SMART) will be used to develop and evaluate an adaptive intervention based on physician-patient interaction. Two initial strategies will be tested: (1) a standard strategy involving monthly interactive follow-ups and (2) an enhanced strategy incorporating behavioural incentives into the standard protocol. In the first stage, 320 patients were recruited from 16 villages and were randomised to either strategy. After 6 months, patients with adequate improvement will continue their original strategy, while those with suboptimal progress will be re-randomised to either an enhanced intervention with a reminder or a further version with both the reminder and physician feedback. All interventions will be delivered via a Smart Medical Assistant Telephone Robot (SMAT-R) integrated within routine primary care services. The primary outcome is patient self-management behaviour, assessed using the Hypertension Patient's Self-Management Behaviour Rating Scale; secondary outcomes-including blood pressure, quality of life and acceptability of the intervention-will be collected by trained personnel using standardised procedures and the SMAT-R digital system. Data will be collected at baseline, 6 months and 12 months post-implementation. Marginal structural models will be used to assess the dynamic effects of intervention. DISCUSSION: This study aims to inform the development and evaluation of an adaptive, scalable and technology-assisted intervention to improve self-management behaviours among patients with hypertension in rural primary care settings. Using a SMART design, the trial will generate evidence on optimal sequencing and tailoring of strategies based on behavioural responses. The findings are expected to guide sustainable improvements in chronic disease management within primary care systems in low-resource contexts. ETHICS AND DISSEMINATION: This trial has been approved by the Ethics Committee of West China Forth Hospital and West China School of Public Health, Sichuan University (Gwll2024130). The study was conducted in accordance with the Declaration of Helsinki. All the participants provided written consent before participation. Trial results will be shared through peer-reviewed publications, ClinicalTrials.gov, and with healthcare providers and local health authorities, without publication restrictions. TRIAL REGISTRATION NUMBER: NCT06869031.