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I Change Adherence & Raise Expectations — iCARE  

Cystic Fibrosis Clinical Trial

Official title:
I Change Adherence & Raise Expectations

Clinical Trial 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 receive the Comprehensive Adherence Program (CAP) for 2 years. CAP consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention). The other half of the centers will receive CAP in year 2 of the study. Participants are patients age 11-20 years old who are diagnosed with CF and have been prescribed at least one of the following medications for at least 6 months prior to signing the informed consent: azithromycin, hypertonic saline, Pulmozyme®, TOBI®, or inhaled compounded tobramycin. Rate of refilling prescriptions is the primary outcome with lung function decline rates, exacerbation rates, and patient reported measures including health related quality of life and CF knowledge and skills, as secondary outcomes. A central goal of this study is to test the effectiveness of the comprehensive adherence program (CAP), described above, versus standard care (SC) for adolescents and young adults seen in outpatient CF clinics.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01232478
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 3
Start date October 2009
Completion date March 2015
View Details
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