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

NCT02179710 | Completed

• 1 other identifier: M.O.M.M.I.1
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

adherence; cystic fibrosis; adolescents; adults

Outcome Measures

Primary Outcomes (1)

• Remotely Observed Therapy

  Doses of medication as recorded by bluetooth device

  140 days

Secondary Outcomes (1)

• Morisky Adherence Questionnaire

  140 days

Study Arms (1)

Motivational Interviewing

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

Interventions

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

Also known as: PARI, Altera, Cayston

Motivational Interviewing

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cystic fibrosis over age 8 with difficulties with adherence to aerosolized Caysotn

You may qualify if:

• 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. -

You may not qualify if:

• Inability to give informed consent or assent

Sponsors & Collaborators

• Landon Pediatric Foundation: lead
• Gilead Sciences: collaborator

Study Sites (1)

Pediatric Diagnostic Center

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Aztreonam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monobactams; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chris Landon, MD

  Landon Pediatric Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)