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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179710
• Other study ID #: M.O.M.M.I.1
• Secondary ID: M.O.M.M.I.1
• Status: Completed
• Phase: N/A
• First received: June 30, 2014
• Last updated: September 7, 2016
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Landon Pediatric Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	Pediatric Diagnostic Center	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
Landon Pediatric Foundation	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remotely Observed Therapy	Doses of medication as recorded by bluetooth device	140 days	No
Secondary	Morisky Adherence Questionnaire	Changes in self reported adherence	140 days	No