Recruiting NCT07031323
OnTrackCF: Engagement, Feasibility, and Acceptability Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OnTrackCF.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis (CF), Cystic Fibrosis - Complete. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- 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 a
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Onboarding Completion [Time frame: through study completion, projected to be 1 year]
- Engagement with app features [Time frame: through study completion, projected to be 1 year]
Eligibility criteria
Inclusion criteria
- Diagnosed with CF
- 18+ years of age
- Prescribed a CFTR modulator therapy to be taken twice a day
- Can speak and read English
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 3 centers
- University of Alabama-Birmingham — Birmingham
- Johns Hopkins University — Baltimore
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT07031323 · IRB-P00050537