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

NCT01013896 | Completed DMC

• 2 other identifiers: NA_00025417R01HL087997-02
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

Cystic Fibrosis Education

ACTIVE COMPARATOR

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

Motivational Interviewing

EXPERIMENTAL

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

Interventions

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).

Motivational Interviewing

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.

Cystic Fibrosis Education

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kristin A Riekert, Ph.D.

  The Johns Hopkins Adherence Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, The Johns Hopkins Adherence Research Center

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 16, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (1)