iCARE: I Change Adherence & Raise Expectations

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT01232478

Collaborator

Genentech, Inc. (Industry), Cystic Fibrosis Foundation (Other), Novartis (Industry), University of Miami (Other)

641

Enrollment

Locations

Arms

Duration (Months)

35.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Behavioral: Comprehensive Adherence Program (CAP)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

641 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

I Change Adherence & Raise Expectations

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Medication Adherence [12 Months]
Medication Possession Ratio (MPR) derived from pharmacy refill records

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UAB/CHS Cystic Fibrosis Center	Birmingham	Alabama	United States	35233
2	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016
3	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
4	Children's Memorial Hospital	Chicago	Illinois	United States	60614
5	Riley Hospital for Children	Indianapolis	Indiana	United States	46202
6	Maine Medical Center	Portland	Maine	United States	04101
7	Children's Hospital Boston	Boston	Massachusetts	United States	02115
8	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
9	Women and Children's Hospital of Buffalo	Buffalo	New York	United States	14222
10	University of Rochester Medical Center	Rochester	New York	United States	14642
11	Duke University Medical Center	Durham	North Carolina	United States	27710
12	Akron Children's Hospital	Akron	Ohio	United States	44308
13	Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
14	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
15	Toledo Children's Hospital	Toledo	Ohio	United States	43606
16	Primary Children's Medical Center	Salt Lake City	Utah	United States	84113
17	Seattle Children's Hospital	Seattle	Washington	United States	98105
18	West Virginia University	Morgantown	West Virginia	United States	26506