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OpenTrials
Completed

NCT Number: NCT01013896

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

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).

Cystic Fibrosis Education

Other

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.

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Building Adherence to Live With And Navigate my CF Experience

Acronym: BALANCE

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Nov 16, 2009
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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