Smart Symptom Tracking ALEX Application for Tracking and Monitoring Gastrointestinal Health, Smart Horizons Pilot Trial

May 26, 2026 updated by: Mayo Clinic

Smart Horizons Pilot: A Feasibility and Outcomes Evaluation of Digital Symptom Tracking for Gastrointestinal Health

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Enhancing Technology & Communication in Healthcare (ETCH) Lab
  • Phone Number: 904-953-5375
  • Email: ETCH@mayo.edu

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Janice L. Krieger, PhD
        • Contact:
          • Enhancing Technology & Communication in Healthcare (ETCH) Lab
          • Phone Number: 904-953-5375
          • Email: ETCH@mayo.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages 18-44 years
  • Concerned about their GI health
  • Able to speak and read English
  • Willing to complete a four-week symptom tracking protocol

Exclusion Criteria:

  • Unable to understand the informed consent or comply with protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (Smart Symptom Tracking ALEX)
Participants engage with the Smart Symptom Tracking ALEX app daily and receive reminders weekly for 4 weeks.
Other: Questionnaire Administration
Ancillary studies
Other: Artificial Intelligence-based Intervention
Engage with the Smart Symptom Tracking ALEX app
Other Names:
  • AI Intervention
  • AI-based Intervention
Other: Communication Intervention
Receive reminders
Active Comparator: Arm 2 (paper logs)
Participants complete paper logs daily and receive reminders weekly for 4 weeks.
Other: Questionnaire Administration
Ancillary studies
Other: Communication Intervention
Receive reminders
Other: Best Practice
Complete paper logs
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gastrointestinal self-advocacy
Time Frame: At baseline and at 4 weeks
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.
At baseline and at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom-tracking frequency
Time Frame: Over 4 weeks
Will be defined as the number of entries logged (ALEX application or pencil-paper logs).
Over 4 weeks
Symptom-report detail and quality
Time Frame: Up to 4 weeks
Will be assessed by qualitative review of report detail (e.g., presence of descriptors, specificity, and red-flag indicators). Will be reported using descriptive summaries of coding categories.
Up to 4 weeks
Communication readiness and symptom-disclosure confidence
Time Frame: At baseline and at week 4
Will be measured by 4 self-report questions answered on a Likert-type scale where 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=somewhat confident, and 5=extremely confident. Higher scores indicate greater confident in readiness to communication symptoms with confidence.
At baseline and at week 4
Intervention acceptability and usability (ALEX arm only)
Time Frame: Up to 4 weeks
Will be measured using the 2-question System Usability Scale (answered on a scale of 1-5 where 1=strongly disagree and 5=strongly agree) or other study-specific acceptability measures. Will be reported using descriptive statistics of acceptability and usability scores.
Up to 4 weeks
Engagement metrics (ALEX arm)
Time Frame: Up to 4 weeks
Will measure application analytics (days with entries, interaction with coaching modules, and notifications opened). Will be reported using descriptive summaries (median daily engagement).
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Janice Krieger, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

April 20, 2029

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-000152

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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