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

Johns Hopkins University

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: Motivational Interviewing; Other: Cystic Fibrosis Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01013896

R01HL087997-02 (U.S. NIH Grant/Contract)

NA_00025417

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

128 participants in 2 patient groups

Cystic Fibrosis Education

Active Comparator group

Description:

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.

Treatment:

Other: Cystic Fibrosis Education

Motivational Interviewing

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Interviewing