Cystic Fibrosis
Conditions
Keywords
adherence, cystic fibrosis, adolescents, adults
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.
Interventions
BEHAVIORALAdherence 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
Gilead Sciences
Landon Pediatric Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remotely Observed Therapy | 140 days | Doses of medication as recorded by bluetooth device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morisky Adherence Questionnaire | 140 days | Changes in self reported adherence |
Countries
United States
Outcome results
None listed