I Change Adherence & Raise Expectations
Public ClinicalTrials.gov record NCT01232478. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01232478
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 641 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 11 Years to 20 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2009 (Type not available)
- Primary completion
- Mar 2015 (Actual)
- Completion
- Mar 2015 (Actual)
- Last update posted
- Sep 13, 2021
2009 – 2015
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB/CHS Cystic Fibrosis Center | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Maine Medical Center | Portland | Maine | 04101 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Women and Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Toledo Children's Hospital | Toledo | Ohio | 43606 | — |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01232478, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 13, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01232478 live on ClinicalTrials.gov.