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

NCT ID: NCT02179710

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-09-30

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.

Conditions

Cystic Fibrosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Adherence dashboard motivational interviewing

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

PARI; Altera; Cayston

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Landon Pediatric Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Landon, MD

Role: PRINCIPAL_INVESTIGATOR

Landon Pediatric Foundation

Locations

Pediatric Diagnostic Center

Ventura, California, United States

Countries

United States

Other Identifiers

M.O.M.M.I.1

Identifier Type: REGISTRY

Identifier Source: secondary_id

M.O.M.M.I.1

Identifier Type: -

Identifier Source: org_study_id