I Change Adherence & Raise Expectations

Cystic Fibrosis Clinical Trial

— iCARE  

Official title:

I Change Adherence & Raise Expectations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232478
• Other study ID #: iCARE
• Status: Completed
• Phase: Phase 3
• Start date: October 2009
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 641
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Comprehensive Adherence Program (CAP)
The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	UAB/CHS Cystic Fibrosis Center	Birmingham	Alabama
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Women and Children's Hospital of Buffalo	Buffalo	New York
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	West Virginia University	Morgantown	West Virginia
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Maine Medical Center	Portland	Maine
United States	University of Rochester Medical Center	Rochester	New York
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington
United States	Toledo Children's Hospital	Toledo	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	Cystic Fibrosis Foundation, Genentech, Inc., Novartis, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Medication Possession Ratio (MPR) derived from pharmacy refill records	12 Months
Secondary	CF knowledge		24 Months
Secondary	Skills associated with CF treatments		24 Months
Secondary	Health Related Quality of Life (HRQOL)	Cystic Fibrosis Questionnaire- Revised	24 Months
Secondary	Lung Function	Forced expiratory volume in one second (FEV1) percent predicted (abstracted from CF registry)	24 Months
Secondary	Pulmonary exacerbation	IV antibiotic treatment (abstracted from CF registry)	24 months
Secondary	CF hospitalizations	Clinic report of pulmonary hospitalization (abstracted from CF registry)	24 Months