Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
641 participants
INTERVENTIONAL
2009-10-31
2015-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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).
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 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)
11 Years
20 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Cystic Fibrosis Foundation
OTHER
Novartis
INDUSTRY
University of Miami
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Kristin A Riekert, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Alexandra L Quittner, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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UAB/CHS Cystic Fibrosis Center
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Maine Medical Center
Portland, Maine, United States
Children's Hospital Boston
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Women and Children's Hospital of Buffalo
Buffalo, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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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.
Other Identifiers
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iCARE
Identifier Type: -
Identifier Source: org_study_id
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