I Change Adherence & Raise Expectations

Study Overview
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Brief Summary
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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.

Official Title
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I Change Adherence & Raise Expectations

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Comprehensive Adherence Program (CAP)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive Adherence Program (CAP)<br>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)<br>* The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).<br>|
| Experimental: Standard Care (SC)<br>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)<br>* The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Medication Possession Ratio (MPR) derived from pharmacy refill records | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CF knowledge |  | 24 Months | 
| Skills associated with CF treatments |  | 24 Months | 
| Health Related Quality of Life (HRQOL) | Cystic Fibrosis Questionnaire- Revised | 24 Months | 
| Lung Function | Forced expiratory volume in one second (FEV1) percent predicted (abstracted from CF registry) | 24 Months | 
| Pulmonary exacerbation | IV antibiotic treatment (abstracted from CF registry) | 24 months | 
| CF hospitalizations | Clinic report of pulmonary hospitalization (abstracted from CF registry) | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Adherence, Problem-Solving, Adolescents, Education, Skills Remediation