Cystic Fibrosis (CF), Cystic Fibrosis - Complete
Conditions
Keywords
adherence, mHealth, mobile health, digital health, medication adherence, CFTR Modulators
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).
Interventions
BEHAVIORALOnTrackCF
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.
Sponsors
Cystic Fibrosis Foundation
Johns Hopkins University
University of Alabama at Birmingham
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactEmma M McWilliams, BA
Backup ContactCallie Bacon, MPH
Outcome results
None listed