OnTrackCF app to support twice-daily CFTR modulator use in adults
OnTrackCF: Engagement, Feasibility, and Acceptability Study
This project will try an app called OnTrackCF to see if adults with cystic fibrosis find it easy to use and whether it helps them stick to their twice-daily CFTR modulator medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 3 sites (Birmingham, Alabama and 2 other locations) |
| Trial ID | NCT07031323 on ClinicalTrials.gov |
What this trial studies
OnTrackCF is a mobile health intervention tested in a multi-site, nonrandomized mixed-methods design among adults with cystic fibrosis who take twice-daily CFTR modulators. Participants use the OnTrackCF app on their iOS or Android smartphone or tablet while researchers collect app usage metrics, patient-reported surveys, and qualitative interviews to measure engagement, feasibility, and acceptability. The study is conducted at three U.S. sites (Boston, Baltimore, Birmingham) and focuses on real-world usability rather than clinical outcomes. Results will guide refinements to the app and the planning of larger efficacy trials.
Who should consider this trial
Good fit: Adults (18+) with a diagnosis of cystic fibrosis who are prescribed a twice-daily CFTR modulator, can read and speak English, and have regular access to an iOS or Android smartphone or tablet are ideal candidates.
Not a fit: People not taking a twice-daily CFTR modulator, those without regular smartphone or internet access, or non-English speakers are unlikely to benefit from this app.
Why it matters
Potential benefit: If successful, the app could help adults with CF maintain regular use of their CFTR modulators and support daily self-management.
How similar studies have performed: Previous mHealth and adherence-support studies in cystic fibrosis and other chronic conditions have shown modest improvements in medication-taking and high acceptability, but long-term clinical benefits remain uncertain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with CF 2. 18+ years of age 3. Prescribed a CFTR modulator therapy to be taken twice a day 4. Can speak and read English 5. Have regular access to an iOS or Android tablet or smartphone with internet access. Exclusion Criteria: 1\) Any situation, in the opinion of the Investigator, that would compromise the safety of the patient or the quality of the data
Where this trial is running
Birmingham, Alabama and 2 other locations
- University of Alabama-Birmingham — Birmingham, Alabama, United States (Not_yet_recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Not_yet_recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kristin Riekert, PhD — Johns Hopkins University
- Study coordinator: Emma M McWilliams, BA
- Email: emma.mcwilliams@childrens.harvard.edu
- Phone: 617-355-7534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.