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

Building Adherence to Live With And Navigate my CF Experience

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01013896
Acronym
BALANCE
Enrollment
128
Registered
2009-11-16
Start date
2009-07-31
Completion date
2014-05-31
Last updated
2015-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Interventions

BEHAVIORALMotivational 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).

OTHERCystic 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted.12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026