JMIR Publications

ABSTRACT

Background:

Unobtrusive digital monitoring technologies are increasingly embedded in digital health research and precision medicine, yet their translation into routine clinical practice remains theoretically underdeveloped. Clinical trials serve as a critical site of integration, where nurses function as pivotal sociotechnical intermediaries connecting patients, digital infrastructures, and research protocols. Despite their central role, there is limited theory explaining how nurses initiate, negotiate, and sustain engagement across the lifecycle of digital health clinical trials.

Objective:

To develop an explanatory grounded theory that elucidates the sociotechnical processes through which nurses engage with clinical trials involving unobtrusive digital monitoring technologies, and to explain how research protocols are translated into everyday clinical practice.

Methods:

A constructivist grounded theory design was employed. Between March and September 2025, registered nurses with experience leading, coordinating, or implementing digital monitoring–related clinical trials were recruited from two tertiary teaching hospitals in China using purposive and theoretical sampling. Data were collected through semi-structured interviews and focus groups and analysed using iterative initial, focused, and theoretical coding with constant comparison until theoretical saturation was achieved.

Results:

Twenty-three nurses participated. Analysis yielded the Supported Translation Theory, which conceptualizes nurse engagement as a dynamic, iterative process of sociotechnical translation rather than a discrete act of protocol compliance. Engagement unfolds through four interdependent domains: individual readiness, organizational climate, technological integration, and socio-ethical and cultural trust. The theory is operationalized through the NURSE Model (Navigating Uncertainty, mobilising Resources, seeking Support, and achieving Empowerment), which captures the core strategies nurses employ to sustain engagement over time.

Conclusions:

The Supported Translation Theory advances theoretical understanding of nurse engagement in digital health clinical trials by reframing nurses as active translators and co-producers of digital research in practice. By explicating the mechanisms through which engagement is sustained, this theory contributes to implementation science and offers a transferable conceptual framework to guide the design, management, and scaling of digital health trials involving unobtrusive monitoring technologies. Clinical Trial: NA