NCT02179710

Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Landon Pediatric Foundation · Academic / Other
• Sex: All
• Age: 8 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a systematic approach to linking treatment and feedback components to enhance adherence.

Detailed description

Study Design: This will be a single group intervention involving a 28-day baseline (Phase 1), a 28-day treatment period with enhanced adherence feedback. Subjects will be treated with Cayston via a blue tooth enabled nebulizer.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
BEHAVIORAL	Adherence dashboard motivational interviewing	These data will be aggregated and displayed graphically in weekly intervals. Adherence will be displayed as percentage and timing percentage within a set criterion of prescribed inter-dose interval. Drug holidays, operationally defined as missing two or more consecutive doses will be displayed along with average length. Patient self-reported adherence information, collected via handheld (i.e, smart phone, tablet, laptop) application will be displayed as percentage and timing percentage on the dashboard. Review of dashboard weekly with investigator for motivational interviewing

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-07-02
• Last updated: 2016-09-08

Locations

1 site across 1 country: United States