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. 2014 Jun 18;2014(6):CD003148. doi: 10.1002/14651858.CD003148.pub3

Quittner 2011.

Study name RCT of a behavioral adherence intervention for adolescents with CF: I change adherence and raise expectations (iCARE)
Methods Study design: clustered‐randomised controlled study.
The study is evaluating two adherence promotion interventions for adolescents, implemented by CF care teams. The centres are randomised to one of the types of interventions.
Half of the centres will receive the Comprehensive Adherence Program (CAP) for 2 years. The other half will receive the Adherence Dashboard only in year 1 of the study and CAP in year 2 of the study.
Participants Enrolled: 632 adolescents.
Population of interest: adolescents diagnosed with CF who are prescribed chronic use of a pulmonary medication.
Inclusion criteria:
1. male or female patients age 11‐120 years old;.
2. patients with a diagnosis of CF;
3. patients attend the accredited care centre for regularly scheduled clinic visits;
4. 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);
5. Patient has consented to provide data to the CF Foundation Registry prior to conversion to PORTCFv.
Interventions Comprehensive Adherence Program (CAP) consists of:
1. Adherence Dashboard ‐ a web‐based resource offering automated/regularly updated patients adherence estimates (based on pharmacy refill patterns and health information retrieved from registry);
2. Training in the CF My Way program ‐ a validated problem‐solving adherence promotion intervention.
Outcomes Primary outcome
Medication adherence will be assessed via MPR derived from pharmacy refill records. (Time frame 24 months.)
Secondary outcomes (Time frame 24 months.)
CF knowledge 
Skills associated with CF treatments
Health‐related quality of life (CFQ‐R)
Lung function (FEV1)
Pulmonary exacerbation
CF hospitalizations
Starting date October 2009.
Contact information Prof. Alexandra Quittner, University of Miami, Department of Psychology.
Notes This study is ongoing and is currently recruiting participants (31st July 2012). http://www.clinicaltrials.gov/ct2/show/record/NCT01232478?term=icare+adherence&rank=1)