Cystic Fibrosis (CF)OnTrackCFNCT07031323
OnTrackCF: Engagement, Feasibility, and Acceptability Study
A study testing OnTrackCF in people with Cystic Fibrosis (CF) and Cystic Fibrosis - Complete, run by Boston Children's Hospital at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis (CF), Cystic Fibrosis - Complete
- What is being tested?
- OnTrackCF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Nov 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) Any situation, in the opinion of the Investigator, that would compromise the safety of the patient or the quality of the data
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21218
University of Alabama-Birmingham
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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
- Being tested
- OnTrackCF
- Keywords
- adherence, mHealth, mobile health, digital health, medication adherence, CFTR Modulators
- Medical subject headings
- Cystic Fibrosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnTrackCFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participation | Experimental | 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. Receives: Behavioral: OnTrackCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Survey (SUS)
By the last round of testing, the System Usability Survey (SUS) will have a median score of 75%.
Measured: through study completion, projected to be 1 year
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).
Measured: through study completion, projected to be 1 year
Secondary outcomes (2)
Onboarding Completion
By the last round of testing, 90% of participants will complete the app onboarding process.
Measured: through study completion, projected to be 1 year
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.
Measured: through study completion, projected to be 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start20 Nov 2025
- Primary completion18 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Johns Hopkins University, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Gregory Sawicki, Boston Children's Hospital
- Investigators
- Kristin Riekert, PhD, Principal investigator, Johns Hopkins UniversityGabriela Oates, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031323
- Sponsor's protocol ID
- IRB-P00050537
- Acronym
- OnTrackCF
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OnTrackCF: Engagement, Feasibility, and Acceptability Study
- ClinicalTrials.gov ID
- NCT07031323
- Acronym / sponsor ID
- OnTrackCF / IRB-P00050537
- Conditions
- Cystic Fibrosis (CF), Cystic Fibrosis - Complete
- Keywords
- adherence, mHealth, mobile health, digital health, medication adherence, CFTR Modulators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Johns Hopkins University, University of Alabama at Birmingham
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 18 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participation | Experimental | Behavioral: OnTrackCFParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Any situation, in the opinion of the Investigator, that would compromise the safety of the patient or the quality of the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnTrackCFOnTrackCF 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. | Behavioural | Participation |
Primary outcome
System Usability Survey (SUS)
Time frame: 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)
Time frame: 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).
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Riekert, PhD principal investigator
Johns Hopkins University
Gabriela Oates, PhD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OnTrackCF in people with Cystic Fibrosis (CF) and Cystic Fibrosis - Complete, run by Boston Children's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Survey (SUS) (time frame: through study completion, projected to be 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.