Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Adherence, Problem-Solving, Adolescents, Education, Skills Remediation
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.
Interventions
BEHAVIORALComprehensive Adherence Program (CAP)
The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).
Sponsors
Genentech, Inc.
Cystic Fibrosis Foundation
Novartis
University of Miami
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 12 Months | Medication Possession Ratio (MPR) derived from pharmacy refill records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skills associated with CF treatments | 24 Months | — |
| Health Related Quality of Life (HRQOL) | 24 Months | Cystic Fibrosis Questionnaire- Revised |
| CF knowledge | 24 Months | — |
| Pulmonary exacerbation | 24 months | IV antibiotic treatment (abstracted from CF registry) |
| CF hospitalizations | 24 Months | Clinic report of pulmonary hospitalization (abstracted from CF registry) |
| Lung Function | 24 Months | Forced expiratory volume in one second (FEV1) percent predicted (abstracted from CF registry) |
Countries
United States
Outcome results
None listed