Recruiting

OnTrackCF

Sponsor:

Boston Children's Hospital

Code:

NCT07031323

Conditions

Cystic Fibrosis (CF)

Cystic Fibrosis - Complete

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OnTrackCF

Study Details

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).

Conditions

Cystic Fibrosis (CF)

Cystic Fibrosis - Complete

Study ID

NCT07031323

Start date

Nov 20, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • System Usability Survey (SUS) [ Time Frame: through study completion, projected to be 1 year ]
  • Intervention Feasibility and Acceptability (iFAQ) [ Time Frame: through study completion, projected to be 1 year ]

Central Contacts and Locations

Central contacts

Emma M McWilliams, BA

617-355-7534emma.mcwilliams@childrens.harvard.edu

Callie Bacon, MPH

617-919-7696callie.bacon@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Gregory Sawicki

617-355-1900gregory.sawicki@childrens.harvard.edu

Principal Investigator:

Gregory Sawicki, MD, MPH

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • adherence
  • mHealth
  • mobile health
  • digital health
  • medication adherence
  • CFTR Modulators

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-12-05.