I Change Adherence & Raise Expectations (iCARE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech
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
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Behavioral: Comprehensive Adherence Program (CAP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: I Change Adherence & Raise Expectations

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Medication Adherence [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Medication Possession Ratio (MPR) derived from pharmacy refill records


Secondary Outcome Measures:
  • 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)


Enrollment: 641
Study Start Date: October 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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).

  Eligibility

Ages Eligible for Study:   11 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232478

Locations
United States, Alabama
UAB/CHS Cystic Fibrosis Center
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04101
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, New York
Women and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Toledo Children's Hospital
Toledo, Ohio, United States, 43606
United States, Utah
Primary Children's Medical Center
Salt Kale City, Utah, United States, 84113
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Johns Hopkins University
Genentech
Cystic Fibrosis Foundation
Novartis
University of Miami
Investigators
Principal Investigator: Kristin A Riekert, PhD Johns Hopkins University
Principal Investigator: Alexandra L Quittner, PhD University of Miami
  More Information

No publications provided

Responsible Party: Kristin A. Riekert, PhD, Co-Director, Johns Hopkins Adherence Research Center (JHARC), Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01232478     History of Changes
Other Study ID Numbers: iCARE
Study First Received: October 28, 2010
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Cystic Fibrosis
Adherence
Problem-Solving
Adolescents
Education
Skills Remediation

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014