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I Change Adherence & Raise Expectations (iCARE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech, Inc.
Cystic Fibrosis Foundation
Novartis
University of Miami
Information provided by (Responsible Party):
Kristin A. Riekert, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01232478
First received: October 28, 2010
Last updated: January 22, 2014
Last verified: January 2014

October 28, 2010
January 22, 2014
October 2009
June 2014   (final data collection date for primary outcome measure)
Medication Adherence [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Medication Possession Ratio (MPR) derived from pharmacy refill records
Medication Adherence [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Medication Possession Ratio (MPR) derived from pharmacy refill records
Complete list of historical versions of study NCT01232478 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
I Change Adherence & Raise Expectations
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 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Cystic Fibrosis
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).
  • Experimental: Comprehensive Adherence Program (CAP)
    The comprehensive adherence program emphasizes the patient's active, collaborative role in identifying adherence barriers and solving them to improve adherence to prescribed treatment regimens. Problem-solving sessions will be used to address barriers to adherence that are identified by the adolescent. The intervention also includes provision of a written, Prescribed Treatment Plan, assessment and remediation of gaps in Knowledge of Disease Management, and evaluation and re-instruction/re-training of skills needed to perform daily treatments.
    Intervention: Behavioral: Comprehensive Adherence Program (CAP)
  • Experimental: Standard Care (SC)
    Standard care (SC) for adolescents and young adults seen in outpatient CF clinics in Year 1 of the Study. CAP intervention during Year 2 of the Study.
    Intervention: Behavioral: Comprehensive Adherence Program (CAP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
641
June 2015
June 2014   (final data collection date for primary outcome measure)

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)
Both
11 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01232478
iCARE
No
Kristin A. Riekert, PhD, Johns Hopkins University
Johns Hopkins University
  • Genentech, Inc.
  • Cystic Fibrosis Foundation
  • Novartis
  • University of Miami
Principal Investigator: Kristin A Riekert, PhD Johns Hopkins University
Principal Investigator: Alexandra L Quittner, PhD University of Miami
Johns Hopkins University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP