An interventional study of Motivational Interviewing and Cystic Fibrosis Education in Cystic Fibrosis, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-03-31.
Sponsored by Johns Hopkins University · Not applicable and Interventional
The investigators research group and others have found that patient-reported adherence to all aspects of the regimen is suboptimal and objective measures suggest even poorer adherence. There is little data, however that identifies and examines the reason for nonadherence in an adult Cystic Fibrosis (CF) population or identifies effective strategies for improving adherence.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 128 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Cystic Fibrosis Education
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.
Behavioral: 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).
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.
A medication possession ratio (MPR) will be calculated for each prescribed drug that is being monitored for adherence.
Time frame: 12 months
Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted.
Time frame: 12 months
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University