Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01232478
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2010-10-28
Brief Title:
I Change Adherence Raise Expectations
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
I Change Adherence Raise Expectations
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iCARE
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None