Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis

Alexandra L Quittner; Michelle N Eakin; Adrianne N Alpern; Alana K Ridge; Katherine A McLean; Andrew Bilderback; Kristen K Criado; Shang-En Chung; Kristin A Riekert

doi:10.1016/j.jcf.2019.05.004

Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis

J Cyst Fibros. 2019 Nov;18(6):879-885. doi: 10.1016/j.jcf.2019.05.004. Epub 2019 May 15.

Authors

Alexandra L Quittner¹, Michelle N Eakin², Adrianne N Alpern³, Alana K Ridge², Katherine A McLean³, Andrew Bilderback², Kristen K Criado³, Shang-En Chung², Kristin A Riekert²

Affiliations

¹ Nicklaus Children's Research Institute, Nicklaus Children's Hospital, Miami, FL, USA. Electronic address: [email protected].
² Department of Medicine, Division of Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.
³ Department of Psychology, University of Miami, P.O. Box 248185, Miami, FL, USA.

PMID: 31103533
DOI: 10.1016/j.jcf.2019.05.004

Abstract

Background: In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence.

Methods: iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11-20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months.

Results: Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25-100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC.

Conclusions: The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified.

Trial registry: ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.

Keywords: Adherence; Adolescents; Education; Problem-solving.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adolescent Behavior
Ambulatory Care* / methods
Ambulatory Care* / psychology
Behavior Control / methods
Cystic Fibrosis* / drug therapy
Cystic Fibrosis* / psychology
Female
Health Knowledge, Attitudes, Practice
Humans
Internet-Based Intervention
Male
Medication Adherence / psychology*
Outcome Assessment, Health Care
Problem Solving
Quality of Life*
Respiratory System Agents / therapeutic use*
Telemedicine / methods*

Substances

Respiratory System Agents

Associated data

ClinicalTrials.gov/NCT01232478