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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Adherence dashboard motivational interviewing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Motivational Interviewing<br>Review of adherence dashboard by the investigator with the patient to facilitate and engage intrinsic motivation within the client in order to change behavior. | Behavioral: Adherence dashboard motivational interviewing<br>* 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<br>* Other names: Cayston;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remotely Observed Therapy | Doses of medication as recorded by bluetooth device | 140 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morisky Adherence Questionnaire | Changes in self reported adherence | 140 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, cystic fibrosis, adolescents, adults