Cystic FibrosisPhase 3iCARENCT01232478
I Change Adherence & Raise Expectations
A Phase 3 study testing Comprehensive Adherence Program (CAP) in people with Cystic Fibrosis, run by Johns Hopkins University at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 20 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Comprehensive Adherence Program (CAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 641 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2009to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Akron Children's Hospital
Akron, Ohio, 44308
University of Michigan Health System
Ann Arbor, Michigan, 48109
UAB/CHS Cystic Fibrosis Center
Birmingham, Alabama, 35233
Children's Hospital Boston
Boston, Massachusetts, 02115
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222
Children's Memorial Hospital
Chicago, Illinois, 60614
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
Duke University Medical Center
Durham, North Carolina, 27710
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Riley Hospital for Children
Indianapolis, Indiana, 46202
West Virginia University
Morgantown, West Virginia, 26506
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Maine Medical Center
Portland, Maine, 04101
University of Rochester Medical Center
Rochester, New York, 14642
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
Toledo Children's Hospital
Toledo, Ohio, 43606
About this study
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Comprehensive Adherence Program (CAP)
- Keywords
- Cystic Fibrosis, Adherence, Problem-Solving, Adolescents, Education, Skills Remediation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Adherence Program (CAP)Behavioural
The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Adherence Program (CAP) | Experimental | 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. Receives: Behavioral: Comprehensive Adherence Program (CAP) |
| Standard Care (SC) | Experimental | 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. Receives: Behavioral: Comprehensive Adherence Program (CAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Medication Possession Ratio (MPR) derived from pharmacy refill records
Measured: 12 Months
Secondary outcomes (6)
CF knowledge
Measured: 24 Months
Skills associated with CF treatments
Measured: 24 Months
Health Related Quality of Life (HRQOL)
Cystic Fibrosis Questionnaire- Revised
Measured: 24 Months
Lung Function
Forced expiratory volume in one second (FEV1) percent predicted (abstracted from CF registry)
Measured: 24 Months
Pulmonary exacerbation
IV antibiotic treatment (abstracted from CF registry)
Measured: 24 months
CF hospitalizations
Clinic report of pulmonary hospitalization (abstracted from CF registry)
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Cystic Fibrosis Foundation, Novartis, University of Miami
- Responsible party
- Sponsor
- Investigators
- Kristin A Riekert, PhD, Principal investigator, Johns Hopkins UniversityAlexandra L Quittner, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232478
- Sponsor's protocol ID
- iCARE
- Acronym
- iCARE
- Status last verified
- Mar 2015
- First submitted
- 28 Oct 2010
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Quittner AL, Eakin MN, Alpern AN, Ridge AK, McLean KA, Bilderback A, Criado KK, Chung SE, Riekert KA. Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis. J Cyst Fibros. 2019 Nov;18(6):879-885. doi: 10.1016/j.jcf.2019.05.004. Epub 2019 May 15.
PubMed 31103533
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I Change Adherence & Raise Expectations
- ClinicalTrials.gov ID
- NCT01232478
- Acronym / sponsor ID
- iCARE / iCARE
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Adherence, Problem-Solving, Adolescents, Education, Skills Remediation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc., Cystic Fibrosis Foundation, Novartis, University of Miami
- Study start
- Oct 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Adherence Program (CAP) | Experimental | Behavioral: 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. |
| Standard Care (SC) | Experimental | Behavioral: Comprehensive Adherence Program (CAP)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. |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Comprehensive Adherence Program (CAP), Standard Care (SC) |
Primary outcome
Medication Adherence
Time frame: 12 Months
Medication Possession Ratio (MPR) derived from pharmacy refill records
6 secondary outcomes
CF knowledge
Time frame: 24 Months
Skills associated with CF treatments
Time frame: 24 Months
Health Related Quality of Life (HRQOL)
Time frame: 24 Months
Lung Function
Time frame: 24 Months
Pulmonary exacerbation
Time frame: 24 months
CF hospitalizations
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Derived from this study: PubMed 31103533Quittner AL, Eakin MN, Alpern AN, Ridge AK, McLean KA, Bilderback A, Criado KK, Chung SE, Riekert KA. Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis. J Cyst Fibros. 2019 Nov;18(6):879-885. doi: 10.1016/j.jcf.2019.05.004. Epub 2019 May 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin A Riekert, PhD principal investigator
Johns Hopkins University
Alexandra L Quittner, PhD principal investigator
University of Miami
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Comprehensive Adherence Program (CAP) in people with Cystic Fibrosis, run by Johns Hopkins University at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.