I Change Adherence & Raise Expectations
- Conditions
- Cystic Fibrosis
- Interventions
- Behavioral: Comprehensive Adherence Program (CAP)
- Registration Number
- NCT01232478
- Lead Sponsor
- Johns Hopkins University
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 641
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comprehensive Adherence Program (CAP) Comprehensive Adherence Program (CAP) The comprehensive adherence program emphasizes the patient's active, collaborative role in identifying adherence barriers and solving them to improve adherence to prescribed treatment regimens. Problem-solving sessions will be used to address barriers to adherence that are identified by the adolescent. The intervention also includes provision of a written, Prescribed Treatment Plan, assessment and remediation of gaps in Knowledge of Disease Management, and evaluation and re-instruction/re-training of skills needed to perform daily treatments. Standard Care (SC) Comprehensive Adherence Program (CAP) Standard care (SC) for adolescents and young adults seen in outpatient CF clinics in Year 1 of the Study. CAP intervention during Year 2 of the Study.
- Primary Outcome Measures
Name Time Method Medication Adherence 12 Months Medication Possession Ratio (MPR) derived from pharmacy refill records
- Secondary Outcome Measures
Name Time Method CF knowledge 24 Months Skills associated with CF treatments 24 Months Lung Function 24 Months Forced expiratory volume in one second (FEV1) percent predicted (abstracted from CF registry)
Health Related Quality of Life (HRQOL) 24 Months Cystic Fibrosis Questionnaire- Revised
Pulmonary exacerbation 24 months IV antibiotic treatment (abstracted from CF registry)
CF hospitalizations 24 Months Clinic report of pulmonary hospitalization (abstracted from CF registry)
Trial Locations
- Locations (18)
Maine Medical Center
🇺🇸Portland, Maine, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
UAB/CHS Cystic Fibrosis Center
🇺🇸Birmingham, Alabama, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Women and Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States