Tailored system to deliver behavioral intervention and manage data in randomized trials

Area of Science:

• Behavioral intervention science
• Clinical trial methodology
• Health informatics

Background:

• Behavioral intervention trials require consistent delivery and comprehensive process data collection.
• Challenges arise from complex human interactions in real-world settings.
• Ensuring intervention fidelity is crucial for trial integrity.

Purpose of the Study:

• To design a system for high-fidelity intervention delivery and efficient data capture.
• To support a telephone-delivered behavioral counseling intervention for post-total knee replacement patients.
• To increase physical activity and function through structured counseling.

Main Methods:

• A tailored system prompted coaches through a 5-step counseling protocol.
• Features included structured data, automated exchange, user-friendly screens, and real-time reporting.
• The system captured patient goals and conversational data.

Main Results:

• The system managed process data for 92 patients across 12 sessions and 992 telephone calls.
• Over 97% of intervention process data fields were completed.
• Coaches spent minimal time preparing for and documenting sessions.

Conclusions:

• The system effectively supported structured behavioral intervention delivery and data collection.
• It met the specific needs of clinical behavioral intervention trials.
• The system shows potential for future high-fidelity implementation in practice and large-scale trials.