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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
| Johns Hopkins University | OTHER |
| University of Alabama at Birmingham | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Survey (SUS) | By the last round of testing, the System Usability Survey (SUS) will have a median score of 75%. | 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). | through study completion, projected to be 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Onboarding Completion | By the last round of testing, 90% of participants will complete the app onboarding process. | through study completion, projected to be 1 year |
| Engagement with app features |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma M McWilliams, BA | Contact | 617-355-7534 | emma.mcwilliams@childrens.harvard.edu | |
| Callie Bacon, MPH | Contact | 617-919-7696 | callie.bacon@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Riekert, PhD | Johns Hopkins University | Principal Investigator |
| Gabriela Oates, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama-Birmingham | Not yet recruiting | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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.
| through study completion, projected to be 1 year |
| Johns Hopkins University | Not yet recruiting | Baltimore | Maryland | 21218 | United States |
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| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |