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

September 7, 2016 updated by: Landon Pediatric Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Pediatric Diagnostic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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:
  • Cayston
  • PARI
  • Altera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remotely Observed Therapy
Time Frame: 140 days
Doses of medication as recorded by bluetooth device
140 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morisky Adherence Questionnaire
Time Frame: 140 days
Changes in self reported adherence
140 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Landon Pediatric Foundation

Collaborators

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M.O.M.M.I.1 (Registry Identifier: M.O.M.M.I.PBRN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be made available to other users of PARI blue tooth monitoring

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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