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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kristin A. Riekert, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01013896
First received: November 13, 2009
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Cystic Fibrosis
 Behavioral: Motivational Interviewing
Other: Cystic Fibrosis Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Building Adherence to Live With And Navigate my CF Experience

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • A medication possession ratio (MPR) will be calculated for each prescribed drug that is being monitored for adherence. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 153
Study Start Date: July 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 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.
Experimental: 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.
 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).

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013896

Locations
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Kristin A Riekert, Ph.D. The Johns Hopkins Adherence Research Center
  More Information

No publications provided

Responsible Party: Kristin A. Riekert, PhD, Co-Director, The Johns Hopkins Adherence Research Center, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01013896     History of Changes
Other Study ID Numbers: NA_00025417, R01HL087997-02
Study First Received: November 13, 2009
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013