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

Completed

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02179710

Run by

Landon Pediatric Foundation

People needed

18

Starts

2015-03-01

Expected to finish

2016-09-01

Last updated by the study team

2016-09-08

Who can join

Age: 8 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be 18 non-adherent CF patients
• Stratified by age as adult supervised (8-12) adolescents (12-18) and young adults (19-30) and gender
• Balanced for ethnicity and disease severity -Non-adherence status will be determined at screening based on an MAQ score < 6. -

You may not qualify if…

• Inability to give informed consent or assent

Where it is running

• Pediatric Diagnostic Center — Ventura, California, United States

Full record on ClinicalTrials.gov

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