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NCT01232478 · ClinicalTrials.gov registry record · Phase 3
I Change Adherence & Raise Expectations
A Phase 3 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 641
- Enrollment target
NCT01232478: Completed Phase 3 study, sponsored by Johns Hopkins University.
NCT01232478 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 641 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01232478, a Phase 3 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 641 participants
- Enrollment target
Study 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.
Primary Outcome
Medication Possession Ratio (MPR) derived from pharmacy refill records
Interventions
- BEHAVIORAL Comprehensive Adherence Program (CAP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 641 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01232478 record still lists
NCT01232478 is an interventional study that assigns participants to a tested intervention. The registered 641 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which Comprehensive Adherence Program (CAP) is the first listed.
NCT01232478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01232478 about?
NCT01232478 is a clinical study titled "I Change Adherence & Raise Expectations". 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 ...
What is the current status of trial NCT01232478?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 641 participants. The study started on 2009-10. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01232478?
The interventions under investigation include: Comprehensive Adherence Program (CAP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01232478?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01232478's enrollment target sits among peer trials
641 575th of 2000 higher than 1,425 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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