The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit

Area of Science:

• Digital Health
• Clinical Research Methodology
• Respiratory Medicine

Background:

• Observational clinical studies require rigorous validation for mobile health applications.
• Remote data collection via smartphones presents a novel approach to clinical research.

Purpose of the Study:

• To assess the feasibility and data quality of conducting an observational clinical study entirely remotely using a mobile health application.
• To explore the potential of mobile platforms for collecting longitudinal, multidimensional data in a large participant cohort.

Main Methods:

• Recruitment, consent, and enrollment were conducted remotely via smartphone for the Asthma Mobile Health Study.
• Secure bidirectional data flow was established between investigators and 7,593 participants across the United States.
• Longitudinal, multidimensional data (surveys, device data, geolocation, air quality) were prospectively collected from a subset of users over six months.

Main Results:

• The study successfully enrolled a large cohort, including individuals with severe asthma, demonstrating the reach of mobile health platforms.
• Consistent trending and correlation of interrelated variables supported the quality of the prospectively collected data.
• Increased asthma symptom reporting was observed in regions affected by environmental factors like heat, pollen, and wildfires.

Conclusions:

• Mobile health applications are a feasible tool for conducting remote observational clinical studies, enabling large-scale data collection.
• The study highlights the potential of mobile platforms for real-world data acquisition in respiratory medicine.
• Addressing challenges such as selection bias, retention, reporting bias, and data security is crucial for optimizing mobile health research.