Health TrialsbyHealthPanel

OnTrackCF: Engagement, Feasibility, and Acceptability Study

ConditionsCystic Fibrosis (CF)Cystic Fibrosis - Complete
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Children's Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with CF

18+ years of age

Prescribed a CFTR modulator therapy to be taken twice a day

Can speak and read English

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • OnTrackCF

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: ParticipationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

System Usability Survey (SUS)

By the last round of testing, the System Usability Survey (SUS) will have a median score of 75%.

Time frame
through study completion, projected to be 1 year
2

Intervention Feasibility and Acceptability (iFAQ)

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).

Time frame
through study completion, projected to be 1 year

Secondary outcomes

1

Onboarding Completion

By the last round of testing, 90% of participants will complete the app onboarding process.

Time frame
through study completion, projected to be 1 year
2

Engagement with app features

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.

Time frame
through study completion, projected to be 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Cystic Fibrosis Foundation

Collaborator

Johns Hopkins University

Collaborator

University of Alabama at Birmingham

Collaborator

Source ClinicalTrials.gov
Apply now