OnTrackCF: Engagement, Feasibility, and Acceptability Study

Not Applicable

Not yet recruiting

• Conditions: Cystic Fibrosis (CF); Cystic Fibrosis - Complete

• Registration Number: NCT07031323
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
System Usability Survey (SUS)	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%.
Intervention Feasibility and Acceptability (iFAQ)	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 Outcome Measures

Name	Time	Method
Onboarding Completion	through study completion, projected to be 1 year	By the last round of testing, 90% of participants will complete the app onboarding process.
Engagement with app features	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.

Trial Locations

Locations (3)

University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States