MedTrace Logo

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

NCT02179710 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2016-09-08

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Landon Pediatric Foundation

    lead OTHER

Principal Investigators

  • Chris Landon, MD · Landon Pediatric Foundation

Eligibility

Min Age
8 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02179710 on ClinicalTrials.gov