Building Adherence to Live With And Navigate my Cystic Fibrosis (CF) Experience

Study Overview
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Brief Summary
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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.

Official Title
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Building Adherence to Live With And Navigate my CF Experience

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Other: Cystic Fibrosis Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a doctor confirmed diagnosis of CF 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: Burkholderia cepacia complex isolated from the respiratory tract within the past 2 years. Had a lung transplant Participated in NA_00008649 A pilot study of Motivational Interviewing for adults with CF.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cystic Fibrosis Education<br>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<br>* 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.<br>|
| Experimental: Motivational Interviewing<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A medication possession ratio (MPR) will be calculated for each prescribed drug that is being monitored for adherence. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted. |  | 12 months |