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

Cystic Fibrosis Clinical Trial

— BALANCE  

Official title:

Building Adherence to Live With And Navigate my CF Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013896
• Other study ID #: NA_00025417
• Secondary ID: R01HL087997-02
• Status: Completed
• Phase: N/A
• First received: November 13, 2009
• Last updated: March 30, 2015
• Start date: July 2009
• Est. completion date: May 2014

Study information

• Verified date: March 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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).

Other:
• Cystic 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.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A medication possession ratio (MPR) will be calculated for each prescribed drug that is being monitored for adherence.		12 months	No
Secondary	Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted.		12 months	No