Status:
COMPLETED
I Change Adherence & Raise Expectations
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Genentech, Inc.
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
11-20 years
Phase:
PHASE3
Brief Summary
The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement. Half the centers will r...
Eligibility Criteria
Inclusion
- Male or female patients age 11 - 20 years old
- Patients with a diagnosis of CF
- Patients attend the accredited care center for regularly scheduled clinic visits
- Patient must be prescribed at least one of the following medications for at least 6 months prior to signing the informed consent:
- Azithromycin Hypertonic saline Pulmozyme® TOBI® Inhaled compounded tobramycin
- Patient has consented to provide data to the CF Foundation Registry prior to conversion to PORTCFv2
Exclusion
- Patient is planning to change care teams within the next 2 years
- Patient is seen at a satellite clinic
- Patient is on the lung transplant list (Note: participation in this study will not delay or exclude patient from being placed on the transplant list in the future or receiving a transplant once enrolled in the study)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
641 Patients enrolled
Trial Details
Trial ID
NCT01232478
Start Date
October 1 2009
End Date
March 1 2015
Last Update
September 13 2021
Active Locations (18)
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1
UAB/CHS Cystic Fibrosis Center
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
4
Children's Memorial Hospital
Chicago, Illinois, United States, 60614