[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07031323":3,"trial-entities:NCT07031323":127,"trial-summary:NCT07031323":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":27,"primary_purpose":13,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":48,"sex":55,"minimum_age":56,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":111,"overall_officials":120,"references":125,"see_also_links":126},"NCT07031323","IRB-P00050537","OnTrackCF: Engagement, Feasibility, and Acceptability Study","RECRUITING","2026-12","2025-12","2025-12-05","2025-11-20","Boston Children's Hospital","OTHER",false,"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).",null,[18,19],"Cystic Fibrosis (CF)","Cystic Fibrosis - Complete",[21,22,23,24,25,26],"adherence","mHealth","mobile health","digital health","medication adherence","CFTR Modulators","INTERVENTIONAL",[29],"NA",{"count":31,"type":32},60,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"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 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.",[39],"Participation",[41,45],{"measure":42,"description":43,"timeFrame":44},"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",{"measure":46,"description":47,"timeFrame":44},"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).",[49,52],{"measure":50,"description":51,"timeFrame":44},"Onboarding Completion","By the last round of testing, 90% of participants will complete the app onboarding process.",{"measure":53,"description":54,"timeFrame":44},"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.","ALL","18 Years",{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Inclusion Criteria:\n\n1. Diagnosed with CF\n2. 18+ years of age\n3. Prescribed a CFTR modulator therapy to be taken twice a day\n4. Can speak and read English\n5. Have regular access to an iOS or Android tablet or smartphone with internet access.\n\nExclusion Criteria:\n\n1\\) Any situation, in the opinion of the Investigator, that would compromise the safety of the patient or the quality of the data",[62,63],"ADULT","OLDER_ADULT",[65,83,97],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":80},"University of Alabama-Birmingham","NOT_YET_RECRUITING","Birmingham","Alabama","35233","United States",[73,78],{"name":74,"role":75,"phone":76,"email":77},"Gabriela Oates, PhD","CONTACT","(205) 996-5689","goates@uabmc.edu",{"name":74,"role":79},"PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},33.52066,-86.80249,{"facility":84,"status":67,"city":85,"state":86,"zip":87,"country":71,"contacts":88,"geoPoint":94},"Johns Hopkins University","Baltimore","Maryland","21218",[89,93],{"name":90,"role":75,"phone":91,"email":92},"Kristin A. Riekert, PhD","443-286-9313","kriekert@jhmi.edu",{"name":90,"role":79},{"lat":95,"lon":96},39.29038,-76.61219,{"facility":12,"status":7,"city":98,"state":99,"zip":100,"country":71,"contacts":101,"geoPoint":108},"Boston","Massachusetts","02115",[102,106],{"name":103,"role":75,"phone":104,"email":105},"Gregory Sawicki","617-355-1900","gregory.sawicki@childrens.harvard.edu",{"name":107,"role":79},"Gregory Sawicki, MD, MPH",{"lat":109,"lon":110},42.35843,-71.05977,[112,116],{"name":113,"role":75,"phone":114,"email":115},"Emma M McWilliams, BA","617-355-7534","emma.mcwilliams@childrens.harvard.edu",{"name":117,"role":75,"phone":118,"email":119},"Callie Bacon, MPH","617-919-7696","callie.bacon@childrens.harvard.edu",[121,123],{"name":122,"affiliation":84,"role":79},"Kristin Riekert, PhD",{"name":74,"affiliation":124,"role":79},"University of Alabama at Birmingham",[],[],{"nct_id":4,"conditions":128,"biomarkers":130},[129],"Cystic Fibrosis",[],{"nct_id":4,"found":132,"summary":133,"prompt_version":143},true,{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This is a multi-site study that is not randomized, meaning participants are not assigned to groups by chance. It plans to include 60 adult participants with Cystic Fibrosis.","completed","OnTrackCF: App for Cystic Fibrosis Treatment Adherence","This study is looking at an app called OnTrackCF, which was created to help people with Cystic Fibrosis (CF) track their CFTR modulator therapy and symptoms. The goal is to see how easy the app is to use, how well people like it, and how much they use it. You can join if you are 18 or older, have CF, take a CFTR modulator twice a day, speak English, and have a smartphone or tablet with internet. The study plans to enroll 60 participants. Success will be measured by how usable and acceptable the app is to you, over a period of about one year.","Participants will be followed through study completion, which is projected to be one year.",105,"Not specified in the trial record.","Not stated in the trial record.",[36],"v2"]