Smart Horizons Pilot: A Feasibility and Outcomes Evaluation of Digital Symptom Tracking for Gastrointestinal Health
Summary
This clinical trial compares the impact of the Smart Symptom Tracking ALEX application (app) to standard symptom-tracking practices in tracking and monitoring gastrointestinal (GI) symptoms in young adults. Rates of early-onset colorectal cancer are rising sharply and it is projected to become the leading cause of cancer-related death in young adults. Despite this, adults under 45 still face barriers to diagnosis, including access to screening, unclear guidance on the impact of GI symptoms and dismissal of symptoms by healthcare providers. Current screening guidelines lack guidance on monitoring early symptoms in younger adults. The Smart Symptom Tracking ALEX tool is a digital platform that uses artificial intelligence to provide prompts for symptoms, coaching, reminders and education. Standard of care clinical practices include paper-based logs to report symptoms. Using the Smart Symptom Tracking ALEX app may provide more detailed symptom reports and increase self-reported symptom communication compared to standard symptom-tracking practices in young adults concerned about their GI health.
Arms & interventions
- OtherArtificial Intelligence-based Intervention
Engage with the Smart Symptom Tracking ALEX app
- OtherBest Practice
Complete paper logs
- OtherCommunication Intervention
Receive reminders
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Change in gastrointestinal self-advocacy
Will use a 4-items self-report "How confident are you in..." scale and chart-verified data to assess baseline and post-intervention self-advocacy. Questions are answered on a 5-point scale where 1=not at all confident and 5=extremely confident. Higher scores indicate greater self-advocacy confidence. Will compare mean change between arms using analysis of covariance (ANCOVA) or linear regression adjusting for baseline scores. Will estimate effect sizes (Cohen's d) and 95% confidence intervals. Sensitivity analysis will use mixed-effects models for repeated measures.
Time frame: At baseline and at 4 weeks
Secondary
Symptom-tracking frequency
Time frame: Over 4 weeks
Symptom-report detail and quality
Time frame: Up to 4 weeks
Communication readiness and symptom-disclosure confidence
Time frame: At baseline and at week 4
Intervention acceptability and usability (ALEX arm only)
Time frame: Up to 4 weeks
Engagement metrics (ALEX arm)
Time frame: Up to 4 weeks
Eligibility criteria
Study locations (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980