Technology and Human Support Systems in Decentralized Studies: A Participant-Centered Case Study in Cystic Fibrosis

Area of Science:

• Clinical Informatics
• Patient-Centered Research
• Decentralized Clinical Trials

Background:

• Integrating informatics into clinical research transforms decentralized studies.
• Optimizing participant experience is crucial for remote data collection success.
• Prior research highlights the need for deeper understanding of participant perspectives.

Purpose of the Study:

• To analyze participant experiences in a home spirometry study for cystic fibrosis.
• To identify key factors influencing participant engagement in decentralized research.
• To inform the design of participant-centered decentralized studies.

Main Methods:

• Qualitative analysis of 46 participant exit interviews from the OUTREACH study.
• The study focused on a 3-month home spirometry data collection period.
• The analysis identified themes related to motivators, technology, and coordination.

Main Results:

• Participant experience was significantly influenced by technological infrastructure reliability.
• Effective human coordination and interpersonal support were vital for engagement.
• Motivators played a key role in sustained participant involvement.

Conclusions:

• Sociotechnical elements are critical for optimizing participant experience in decentralized studies.
• Enhancing participant engagement through reliable technology and support improves clinical study data quality.
• Participant-centered approaches are essential for successful remote clinical research.