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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
641
The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).
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
...and 8 more locations
Medication Adherence
Medication Possession Ratio (MPR) derived from pharmacy refill records
Time frame: 12 Months
CF knowledge
Time frame: 24 Months
Skills associated with CF treatments
Time frame: 24 Months
Health Related Quality of Life (HRQOL)
Cystic Fibrosis Questionnaire- Revised
Time frame: 24 Months
Lung Function
Forced expiratory volume in one second (FEV1) percent predicted (abstracted from CF registry)
Time frame: 24 Months
Pulmonary exacerbation
IV antibiotic treatment (abstracted from CF registry)
Time frame: 24 months
CF hospitalizations
Clinic report of pulmonary hospitalization (abstracted from CF registry)
Time frame: 24 Months
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