I Change Adherence & Raise Expectations



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:11 - 20
Updated:5/27/2013
Start Date:October 2009
Contact:Alana Ridge
Phone:410-550-6746

Use our guide to learn which trials are right for you!


The iCARE study, a clustered-randomized controlled trial, is evaluating two adherence
promotion interventions 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 the Adherence Dashboard (a web-based resource offering automated and regularly
updated patient adherence estimates based on pharmacy refill patterns that is integrated
with health information abstracted from the CF Foundation-managed patient registry) AND
training in the CF My Way program (a validated problem-solving adherence promotion
intervention). The other half of the centers will receive the Adherence Dashboard only in
year 1 of the study and 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.


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)
We found this trial at
19
sites
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Akron, OH
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300 Longwood Avenue
Boston, Massachusetts 02115
617-355-6000
Children's Hospital - Boston Boston Children's Hospital is a 395-bed comprehensive center for pediatric health...
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Boston, MA
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Cleveland, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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Portland, ME
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
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Salt Lake City, UT
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Ann Arbor, MI
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Birmingham, Alabama 35233
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Birmingham, AL
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Buffalo, NY
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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from
Durham, NC
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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Oakland, California 94611
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Oakland, CA
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Phoenix, AZ
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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Toledo, Ohio 43606
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Toledo, OH
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