Building Adherence to Live With And Navigate my Cystic Fibrosis (CF) Experience
NCT ID: NCT01013896
Last Updated: 2015-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2009-07-31
2014-05-31
Brief Summary
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The investigators propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group). Specifically, The investigators hypothesize that MI will result in improved regimen adherence and reduced CF morbidity compared to the CFE control group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Cystic Fibrosis Education
This intervention is designed to increase knowledge and enhance the skills needed to optimize CF-management. The strategies used to achieve improved adherence include providing didactic education and skills training, and proscriptively using behavioral modification strategies, such as positive reinforcement for desired behaviors, and problem-solving training to overcome barriers.
Cystic Fibrosis Education
Among a group of older adolescents and adults with CF, we propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group).
The Cystic Fibrosis Education serves as the attention control group.
Motivational Interviewing
The Counselor's overarching goal for the intervention is to motivate and assist the participant to improve his/her adherence to the CF pulmonary medications. The intervention will begin by providing the patient personal feedback on their adherence (using pharmacy refill data) and health outcomes (e.g., trajectory of lung function values, frequency of exacerbations) as well as clinic-level figures showing the association between adherence and health outcomes.
Motivational Interviewing
Among a group of older adolescents and adults with CF, we propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group).
Interventions
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Motivational Interviewing
Among a group of older adolescents and adults with CF, we propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group).
Cystic Fibrosis Education
Among a group of older adolescents and adults with CF, we propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group).
The Cystic Fibrosis Education serves as the attention control group.
Eligibility Criteria
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Inclusion Criteria
* Age 16 years old or older
* Prescribed an inhaled mucolytic, inhaled antibiotic therapy, chronic macrolide therapy and/or hypertonic saline therapy for the previous 12 months.
* Scheduled for a regular visit at either the pediatric or the adult CF clinic at Johns Hopkins Hospital.
Exclusion Criteria
* Had a lung transplant
* Participated in NA\_00008649 A pilot study of Motivational Interviewing for adults with CF.
16 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Kristin A. Riekert, PhD
Co-Director, The Johns Hopkins Adherence Research Center
Principal Investigators
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Kristin A Riekert, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Johns Hopkins Adherence Research Center
Locations
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Johns Hopkins
Baltimore, Maryland, United States
Countries
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Other Identifiers
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NA_00025417
Identifier Type: -
Identifier Source: org_study_id
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