I Change Adherence & Raise Expectations

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01232478

Run by

Johns Hopkins University

People needed

641

Starts

2009-10-01

Expected to finish

2015-03-01

Last updated by the study team

2021-09-13

Who can join

Age: 11 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UAB/CHS Cystic Fibrosis Center — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Toledo Children's Hospital — Toledo, Ohio, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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