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Completed

NCT Number: NCT02179710

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

8 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Diagnostic Center

Ventura, California, 93003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adherence dashboard motivational interviewing

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

Other names: PARI, Altera, Cayston

Primary outcomes

  1. Remotely Observed Therapy

    Time frame: 140 days

    Doses of medication as recorded by bluetooth device

Secondary outcomes

  1. Morisky Adherence Questionnaire

    Time frame: 140 days

    Changes in self reported adherence

Sponsors and collaborators

Lead sponsor

Landon Pediatric Foundation

Other

Collaborators

  • Gilead Sciences

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2014
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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