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NCT Number: NCT07031323

OnTrackCF: Engagement, Feasibility, and Acceptability Study

This is a multi-site, nonrandomized study using mixed methods approach to evaluate the feasibility, acceptability, and user engagement of OnTrackCF for adults with Cystic Fibrosis (AWCF).

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Key information

Conditions

Cystic Fibrosis (CF) Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Cystic Fibrosis - Complete Digestive System Diseases Genetic Diseases, Inborn Health Behavior Infant, Newborn, Diseases Lung Diseases Medication Adherence Pancreatic Diseases Patient Acceptance of Health Care Patient Compliance Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama-Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with CF
  • 18+ years of age
  • Prescribed a CFTR modulator therapy to be taken twice a day
  • Can speak and read English
  • Have regular access to an iOS or Android tablet or smartphone with internet access.

Exclusion criteria

  • Any situation, in the opinion of the Investigator, that would compromise the safety of the patient or the quality of the data

Treatment and study plan

OnTrackCF

Behavioral

OnTrackCF is a mHealth application co-developed with Upstream Dream. It is designed specifically to track and support adherence to CFTR modulator therapy. The app allows users to track their modulator intake and disease symptoms while supporting their adherence goals using Behavioral Change Techniques (BCTs) with empirical evidence of efficacy. The BCTs are administered primarily in the form of messages designed to deliver specific BCTs. The app sends up to 3 adherence support messages per day and provides detailed data to the user about their adherence levels, adherence goals, and disease symptoms. This process will continue until we reach an N=60 AWCF enrolled OR demonstrate that we have achieved 12 weeks of sustained user engagement with the app.

Primary outcomes

  1. System Usability Survey (SUS)

    Time frame: through study completion, projected to be 1 year

    By the last round of testing, the System Usability Survey (SUS) will have a median score of 75%.

  2. Intervention Feasibility and Acceptability (iFAQ)

    Time frame: through study completion, projected to be 1 year

    By the last round of testing, the Intervention Feasibility and Acceptability (iFAQ) OnTrackCF scales (Engagement, Feasibility, Acceptability, Usefulness, and Satisfaction) will each have a median score of ≥4 (out of 5).

Secondary outcomes

  1. Onboarding Completion

    Time frame: through study completion, projected to be 1 year

    By the last round of testing, 90% of participants will complete the app onboarding process.

  2. Engagement with app features

    Time frame: through study completion, projected to be 1 year

    By the last round of testing, 70% of onboarded participants will engage with at least one app feature at least once during each week of their study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Callie Bacon, MPH

CONTACT

[email protected]

617-919-7696

Emma M McWilliams, BA

CONTACT

[email protected]

617-355-7534

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Cystic Fibrosis Foundation
  • Johns Hopkins University
  • University of Alabama at Birmingham

Registry information

Acronym: OnTrackCF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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