OnTrackCF: Engagement, Feasibility, and Acceptability Study (OnTrackCF)

December 1, 2025 updated by: Gregory Sawicki, Boston Children's Hospital
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • University of Alabama-Birmingham
        • Principal Investigator:
          • Gabriela Oates, PhD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Not yet recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Kristin A. Riekert, PhD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
        • Principal Investigator:
          • Gregory Sawicki, MD, MPH

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
through study completion, projected to be 1 year
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).
through study completion, projected to be 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, projected to be 1 year
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.
through study completion, projected to be 1 year

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

Collaborators

Johns Hopkins University
University of Alabama at Birmingham
Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Kristin Riekert, PhD, Johns Hopkins University
  • Principal Investigator: Gabriela Oates, PhD, University of Alabama at Birmingham

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 (Actual)

November 20, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 9, 2025

First Submitted That Met QC Criteria

June 18, 2025

First Posted (Actual)

June 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00050537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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