An Automated Research Protocol Adherence System

SmartState was designed to improve the efficiency, quality, and impact of research studies involving human participants. It consists of four main components: a messaging service, a state machine, a conversational AI, and a web-based platform.  

Key features and benefits of SmartState include: 

  • Automated management of participant interactions, communications, and data collection, reducing the workload on researchers and preventing errors or inconsistencies. 
  • Use of finite state machines to track participant progress and ensure adherence to study protocols, preventing critical steps from being skipped. 
  • Integration of a large language model to facilitate natural language interactions with participants, distill conversations into structured data, and automate responses. 
  • Provision of a web-based platform for researchers to access participant logs, reports, and messaging utilities, enabling seamless interaction with the underlying system. 
  • Increased scalability and efficiency for large studies, making it applicable to many research areas. 
  • Detailed auditing capabilities to trace a participant’s exact path through a study, preventing disputes between researchers and participants. 

Citation

For more information on the development of SmartState: An Automated Research Protocol Adherence System read the linked paper.

How Smart State Works

SmartState follows protocol-driven workflows that dynamically adapt based on user input. At its core, SmartState uses finite state machines (FSMs) to track participants’ progress in a study. FSMs model system behavior as a series of transitions between well-defined states. At each step, specific conditions must be met for a transition to occur. These steps include the completion of a task or the passage of time, ensuring the system moves logically from one state to the next.

Once an FSM is created, the paths defined in the graph are fixed and cannot be deviated from. These fixed paths force participants to pass through specific checkpoints or achieve a specific status before reaching a goal, preventing critical steps from being skipped and maintaining a systematic progression.
FSMs provide the added benefit of capturing detailed logs of every message received or sent, every state entered, and the transition followed. This allows researchers to trace a participant’s exact path through a study.

SmartState uses a large language model (LLM) to facilitate communication between the system and participants. The incorporation of an LLM enables the system to better understand natural language inputs from participants, providing structured and thematic data.

A web-based platform is provided for researchers to access all functionality, participant logs, reports, and messaging utilities. The web platform facilitates participant registration, communication, and various analysis functions. Authorized researchers can easily access and download participant metrics, enabling seamless interaction with the underlying system. This innovative and holistic approach ensures that participants’ interactions are captured accurately while researchers benefit from an intuitive, real-time interface that automates and supports data collection and evaluation processes.

Collaborative Projects in Clinical Research using SmartState:

  • Time-Restricted Eating Intervention in Normal and Cognitively Impaired Postmenopausal Women
  • Time-Restricted Eating and Sleep Intervention in College Students
  • Optimal CT
  • Plant-Based Diet for Diabetes Prevention (PBDDP)