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

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Adherence dashboard motivational interviewing

• Registration Number: NCT02179710
• Lead Sponsor: Landon Pediatric Foundation

Brief 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.

Study Timeline

• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Study Start: 2015-03
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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. -

Exclusion Criteria

• Inability to give informed consent or assent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Motivational Interviewing	Adherence dashboard motivational interviewing	Review of adherence dashboard by the investigator with the patient to facilitate and engage intrinsic motivation within the client in order to change behavior.

Primary Outcome Measures

Name	Time	Method
Remotely Observed Therapy	140 days	Doses of medication as recorded by bluetooth device

Secondary Outcome Measures

Name	Time	Method
Morisky Adherence Questionnaire	140 days	Changes in self reported adherence

Trial Locations

Locations (1)

Pediatric Diagnostic Center; 🇺🇸 Ventura, California, United States