I Change Adherence & Raise Expectations
iCARE
1 other identifier
interventional
641
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2009
Longer than P75 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedSeptember 13, 2021
March 1, 2015
5.4 years
October 28, 2010
September 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication Adherence
Medication Possession Ratio (MPR) derived from pharmacy refill records
12 Months
Secondary Outcomes (6)
CF knowledge
24 Months
Skills associated with CF treatments
24 Months
Health Related Quality of Life (HRQOL)
24 Months
Lung Function
24 Months
Pulmonary exacerbation
24 months
- +1 more secondary outcomes
Study Arms (2)
Comprehensive Adherence Program (CAP)
EXPERIMENTALThe 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.
Standard Care (SC)
EXPERIMENTALStandard 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.
Interventions
The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Genentech, Inc.collaborator
- Cystic Fibrosis Foundationcollaborator
- Novartiscollaborator
- University of Miamicollaborator
Study Sites (18)
UAB/CHS Cystic Fibrosis Center
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Maine Medical Center
Portland, Maine, 04101, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Publications (1)
Quittner AL, Eakin MN, Alpern AN, Ridge AK, McLean KA, Bilderback A, Criado KK, Chung SE, Riekert KA. Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis. J Cyst Fibros. 2019 Nov;18(6):879-885. doi: 10.1016/j.jcf.2019.05.004. Epub 2019 May 15.
PMID: 31103533DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin A Riekert, PhD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Alexandra L Quittner, PhD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
November 2, 2010
Study Start
October 1, 2009
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
September 13, 2021
Record last verified: 2015-03