OnTrackCF: Engagement, Feasibility, and Acceptability Study

NCT07031323 | Recruiting

• 1 other identifier: IRB-P00050537
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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).

Conditions

Cystic Fibrosis (CF); Cystic Fibrosis - Complete

Keywords

adherence; mHealth; mobile health; digital health; medication adherence; CFTR Modulators

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Onboarding Completion

  through study completion, projected to be 1 year

• Engagement with app features

  through study completion, projected to be 1 year

Study Arms (1)

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.

Behavioral: OnTrackCF

Interventions

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.

Participation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with CF
• + 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.

You may not qualify if:

• \) Any situation, in the opinion of the Investigator, that would compromise the safety of the patient or the quality of the data

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Cystic Fibrosis Foundation: collaborator
• Johns Hopkins University: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (3)

University of Alabama-Birmingham

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21218, United States

NOT YET RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Medication Adherence

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kristin Riekert, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Gabriela Oates, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Chair of the Success with Therapies Research Consortium

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 22, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (3)