I Change Adherence & Raise Expectations (iCARE)

• CF knowledge [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
• Skills associated with CF treatments [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
• Health Related Quality of Life (HRQOL) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  Cystic Fibrosis Questionnaire- Revised
• Lung Function [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  Forced expiratory volume in one second (FEV1) percent predicted (abstracted from CF registry)
• Pulmonary exacerbation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  IV antibiotic treatment (abstracted from CF registry)
• CF hospitalizations [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  Clinic report of pulmonary hospitalization (abstracted from CF registry)

The iCARE study, a clustered-randomized controlled trial, is evaluating two adherence promotion interventions 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 the Adherence Dashboard (a web-based resource offering automated and regularly updated patient adherence estimates based on pharmacy refill patterns that is integrated with health information abstracted from the CF Foundation-managed patient registry) AND training in the CF My Way program (a validated problem-solving adherence promotion intervention). The other half of the centers will receive the Adherence Dashboard only in year 1 of the study and 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.

The target population for this study is adolescents diagnosed with cystic fibrosis who are prescribed chronic use of a pulmonary medication.

• Behavioral: The Medication Adherence Dashboard
• Behavioral: Comprehensive Adherence Program

• Dashboard
  Intervention: Behavioral: The Medication Adherence Dashboard
• CAP
  Intervention: Behavioral: Comprehensive Adherence Program

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)

• Genentech
• Cystic Fibrosis Foundation