Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial

Brooke L Reidy; Scott W Powers; Christopher S Coffey; Leigh A Chamberlin; Dixie J Ecklund; Elizabeth A Klingner; Jon W Yankey; Leslie L Korbee; Linda L Porter; James Peugh; Marielle A Kabbouche; Joanne Kacperski; Andrew D Hershey; CHAMP Investigators

doi:10.1093/jpepsy/jsab123

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Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial

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Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial

Brooke L Reidy, Scott W Powers, Christopher S Coffey, Leigh A Chamberlin, Dixie J Ecklund, Elizabeth A Klingner, Jon W Yankey, Leslie L Korbee, Linda L Porter, James Peugh, …

Journal of pediatric psychology, Vol.47(4), pp.376-387

12/03/2021

DOI: 10.1093/jpepsy/jsab123

PMCID: PMC9216483

PMID: 34865085

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Abstract

Abstract Objective Examine preventive medication adherence among youth with migraine. Methods Adherence (self-report, pill count, and blood serum drug levels) was assessed as an ancillary study that utilized data from 328 CHAMP Study participants (ages 8–17). CHAMP was a multisite trial of preventive medications. Participants completed a prospective headache diary during a six-month active treatment period during which youth took amitriptyline, topiramate, or placebo pill twice daily. Self-reported medication adherence was collected via daily diary. At monthly study visits, pill count measures were captured. At trial month 3 (trial midpoint) and 6 (end of active trial), blood serum drug levels were obtained. Self-report and pill count adherence percentages were calculated for the active trial period, at each monthly study visit, and in the days prior to participants’ mid-trial blood draw. Percentages of nonzero drug levels were calculated to assess blood serum drug level data. Adherence measures were compared and assessed in context of several sociodemographic factors. Multiple regression analyses investigated medication adherence as a predictor of headache outcomes. Results Self-report and pill count adherence rates were high (over 90%) and sustained over the course of the trial period. Serum drug level adherence rates were somewhat lower and decreased significantly (from 84% to 76%) across the trial period [t (198) = 3.23, p = .001]. Adherence measures did not predict headache days at trial end; trial midpoint serum drug levels predicted headache-related disability. Conclusions Youth with migraine can demonstrate and sustain relatively high levels of medication adherence over the course of a clinical trial.

Details

Title: Subtitle: Multimodal Assessment of Medication Adherence Among Youth With Migraine: An Ancillary Study of the CHAMP Trial
Creators: Brooke L Reidy - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical Center, USA, Department of Pediatrics, University of Cincinnati College of Medicine, USA
Scott W Powers - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical Center, USA, Department of Pediatrics, University of Cincinnati College of Medicine, USA
Christopher S Coffey - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa, USA
Leigh A Chamberlin - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical Center, USA
Dixie J Ecklund - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa, USA
Elizabeth A Klingner - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa, USA
Jon W Yankey - Department of Biostatistics, Clinical Trials Statistical and Data Management Center, University of Iowa, USA
Leslie L Korbee - Academic Regulatory & Monitoring Services, LLC, USA
Linda L Porter - The National Institute of Neurological Disorders and Stroke, USA
James Peugh - Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical Center, USA
Marielle A Kabbouche - Department of Pediatrics, University of Cincinnati College of Medicine, USA, Division of Neurology, Cincinnati Children’s Hospital Medical Center, USA
Joanne Kacperski - Department of Pediatrics, University of Cincinnati College of Medicine, USA, Division of Neurology, Cincinnati Children’s Hospital Medical Center, USA
Andrew D Hershey - Department of Pediatrics, University of Cincinnati College of Medicine, USA, Division of Neurology, Cincinnati Children’s Hospital Medical Center, USA
CHAMP Investigators
Resource Type: Journal article
Publication Details: Journal of pediatric psychology, Vol.47(4), pp.376-387
DOI: 10.1093/jpepsy/jsab123
PMID: 34865085
PMCID: PMC9216483
NLM abbreviation: J Pediatr Psychol
ISSN: 0146-8693
eISSN: 1465-735X
Grant note: DOI: 10.13039/100000065, name: National Institute of Neurological Disorders and Stroke; name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH, award: U01NS076788, U01NS077108; name: NIH-funded T32 fellowship, award: T32DK063929; name: Child Behavior and Nutrition at Cincinnati Children’s Hospital Medical Center; DOI: 10.13039/100000002, name: NIH
Language: English
Date published: 12/03/2021
Academic Unit: Biostatistics
Record Identifier: 9984214695902771

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