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

Landon Pediatric Foundation

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: Adherence dashboard motivational interviewing

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02179710

M.O.M.M.I.1 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 8 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 1 patient group

Motivational Interviewing

Description:

Review of adherence dashboard by the investigator with the patient to facilitate and engage intrinsic motivation within the client in order to change behavior.

Treatment:

Behavioral: Adherence dashboard motivational interviewing