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Completed

NCT Number: NCT01232478

I Change Adherence & Raise Expectations

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

11 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UAB/CHS Cystic Fibrosis Center, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comprehensive Adherence Program (CAP)

Behavioral

The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).

Primary outcomes

  1. Medication Adherence

    Time frame: 12 Months

    Medication Possession Ratio (MPR) derived from pharmacy refill records

Secondary outcomes

  1. CF knowledge

    Time frame: 24 Months

  2. Skills associated with CF treatments

    Time frame: 24 Months

  3. Health Related Quality of Life (HRQOL)

    Time frame: 24 Months

    Cystic Fibrosis Questionnaire- Revised

  4. Lung Function

    Time frame: 24 Months

    Forced expiratory volume in one second (FEV1) percent predicted (abstracted from CF registry)

  5. Pulmonary exacerbation

    Time frame: 24 months

    IV antibiotic treatment (abstracted from CF registry)

  6. CF hospitalizations

    Time frame: 24 Months

    Clinic report of pulmonary hospitalization (abstracted from CF registry)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Cystic Fibrosis Foundation
  • Genentech, Inc.
  • Novartis
  • University of Miami

Registry information

Acronym: iCARE

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2010
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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