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

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Cystic Fibrosis Education; Behavioral: Motivational Interviewing

• Registration Number: NCT01013896
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2014-01
• Study Completion: 2014-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystic Fibrosis Education	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.
Motivational Interviewing	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.

Primary Outcome Measures

Name	Time	Method
A medication possession ratio (MPR) will be calculated for each prescribed drug that is being monitored for adherence.	12 months

Secondary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted.	12 months

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States