OnTrackCF: Engagement, Feasibility, and Acceptability Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Boston Children's Hospital
Study ID
NCT07031323
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis (CF)
  • Cystic Fibrosis - Complete

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Nov 20, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: 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.

Primary Outcome Measure

System Usability Survey (SUS) [ Time Frame: through study completion, projected to be 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama-BirminghamBirminghamAlabama35233
Gabriela Oates, PhD
[email protected]
(205) 996-5689
Gabriela Oates, PhD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21218
Kristin A. Riekert, PhD
[email protected]
443-286-9313
Kristin A. Riekert, PhD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
Gregory Sawicki
[email protected]
617-355-1900
Gregory Sawicki, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama-Birmingham· Birmingham, ALJohns Hopkins University· Baltimore, MDBoston Children's Hospital· Boston, MA

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