OnTrackCF: Engagement, Feasibility, and Acceptability Study
NCT ID: NCT07031323
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-11-20
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Participation
Participants eligible to enroll will be provided with the OnTrackCF app (intervention), and will use the app for 4-12 weeks before completing feasibility measures and a qualitative interview.
OnTrackCF
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.
Interventions
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OnTrackCF
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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Johns Hopkins University
OTHER
University of Alabama at Birmingham
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Gregory Sawicki
Co-Chair of the Success with Therapies Research Consortium
Principal Investigators
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Kristin Riekert, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Gabriela Oates, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama-Birmingham
Birmingham, Alabama, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-P00050537
Identifier Type: -
Identifier Source: org_study_id
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