Nurses' Engagement in Digital Health Clinical Trials Using Unobtrusive Monitoring Technologies: Constructivist Grounded Theory Study.

چکیده اصلی

BACKGROUND: Unobtrusive digital monitoring technologies (UDMTs) enable continuous data collection beyond episodic clinical encounters and are increasingly incorporated into digital health clinical trials. However, their successful use depends on their integration into routine clinical practice. Poor integration can increase hidden nursing workload, disrupt workflows, compromise data quality, and limit the sustainability of digital trials. Although nurses play a central role in coordinating clinical, research, and technological activities, little is known about how they engage with UDMT-enabled clinical trials in everyday practice. OBJECTIVE: The study aims to develop a constructivist grounded theory explaining how nurses engage with UDMT-enabled digital health clinical trials within routine clinical practice. METHODS: Using Charmaz's constructivist grounded theory approach, registered nurses with experience in leading, coordinating, or implementing UDMT-enabled clinical trials were recruited from 2 tertiary teaching hospitals in China through purposive and theoretical sampling. Between February and October 2025, data were generated through semistructured focus groups and individual interviews. Analysis proceeded concurrently with data collection through initial, focused, and theoretical coding, supported by constant comparison, memo writing, and theoretical sampling until theoretical sufficiency was achieved. RESULTS: Twenty-three nurses from 5 UDMT-enabled clinical trials participated. The analysis generated supported translation theory, conceptualizing nurse engagement as a dynamic and situated process of aligning technological systems, clinical workflows, organizational arrangements, and patient expectations during digital clinical trials. Supported translation is enacted through 4 interrelated and coconstitutive processes: developing readiness for engagement, negotiating organizational conditions, integrating technology into clinical practice, and cultivating socioethical trust. Rather than representing sequential stages, these domains interact dynamically and are sustained through the interpretive, relational, and adaptive work of nurses. The findings demonstrate that implementation is not merely a process of technology adoption but an ongoing accomplishment through which nurses produce the conditions necessary for digital trial delivery. CONCLUSIONS: Supported translation theory offers a practice-based explanation of how nurses engage in UDMT-enabled digital health clinical trials by continuously aligning technological, clinical, organizational, and social elements. The theory extends existing implementation perspectives by specifying the nursing work through which digital health interventions become workable in practice and provides a conceptual foundation for future implementation research, intervention design, and workforce development. Further research should examine and refine the theory across diverse digital health settings and technologies.

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