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Randomized Controlled Trial
. 2017 Sep;26(9):2333-2349.
doi: 10.1007/s11136-017-1571-z. Epub 2017 Apr 9.

Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial

E Ann Yeh  1   2 , Stephanie A Grover  3 , Victoria E Powell  4 , Gulay Alper  5 , Brenda L Banwell  6 , Kim Edwards  7 , Mark Gorman  8 , Jennifer Graves  9 , Timothy E Lotze  10 , Jean K Mah  11 , Lauren Mednick  8 , Jayne Ness  12 , Maya Obadia  13   14 , Ruth Slater  7 , Amy Waldman  6 , Emmanuelle Waubant  9 , Carolyn E Schwartz  4   15 ; Pediatric MS Adherence Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial

E Ann Yeh et al. Qual Life Res. 2017 Sep.

Erratum in

Abstract

Purpose: To report the results of a randomized controlled trial using an electronic monitoring device (EM) plus a motivational interviewing (MI) intervention to enhance adherence to disease-modifying therapies (DMT) in pediatric MS.

Methods: Fifty-two youth with MS (16.03 ± 2.2 years) were randomized to receive either MI (n = 25) (target intervention) or a MS medication video (n = 27) (attention control). Primary endpoint was change in adherence. Secondary outcomes included changes in quality of life, well-being and self-efficacy. Random effects modeling and Cohen's effect size computation evaluated intervention impact.

Results: Longitudinal random effect models revealed that the MI group decreased their EM adherence (GroupxTime interaction = -0.19), while increasing frequency of parental DMT reminder (26.01)/administration (11.69). We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23). Parental reminders about medication increased in MI subjects vs controls (d = 0.59 at 3 months; d = 0.70 at 6 months). We found increases in self-reported adherence (d = 0.21) at 3 but not 6 months, fewer barriers to adherence at three (d = -0.58) and six months (d = -0.31), better physical (d = 0.23 at 3 months; d = 0.45 at 6 months), emotional (d = 0.25 at 3 months) and self-efficacy function (d = 0.55 at 3 months; 0.48 at 6 months), but worse well-being, including self-acceptance (d = -0.53 at 6 months) and environmental mastery (d = -0.42 at 3 and 6 months) in intervention as compared to control patients.

Conclusions: Participants receiving MI + EM experienced worsening on objective measures of adherence and increased parental involvement, but improved on some self- and parent-reported measures. MI participants reported improvements in quality of life and self-efficacy, but worsened well-being.

Trial registration: ClinicalTrials.gov NCT02234713.

Keywords: Behavioral intervention; Multiple sclerosis; Pediatric; Quality of life; Well-being.

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Conflict of interest statement

Compliance with ethical standards

Conflict of interest The authors (SG, VEP, GA, KE, MG, TEM, JM, LM, JN, MO, RS, EW and CES) have no relevant conflicts of interest to disclose. EAY and CES wrote the first draft of the manuscript and neither received an honorarium, grant, or other form of payment to do so. BLB serves as a consultant to Novartis for the purposes of a clinical trial and as an unpaid advisor to Biogen, Teva neuroscience and Sanofi. She is also a chief editor for Multiple Sclerosis and Related Disorders and is on the editorial board for Neurology. JG has received grant funding from the Race to Erase MS, Biogen and Genentech. AW has received grant funding from the National Institutes of Health (USA) and Biogen Idec. EAY receives research funding from NMSS, CMSC, OIRM, SCN, CBMH Chase an Idea, SickKids Foundation, Rare Diseases Foundation, MS Scientific Foundation (Canada), McLaughlin Centre, Mario Batalli Foundation. She performs relapse adjudication for ACI, has received unrestricted funding for a symposium from the Guthy Jackson Charitable Foundation and Teva and has served on a Scientific Advisory Board for Neurotoxicity with Juno Pharmaceuticals.

Ethical approval All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent Informed consent was obtained from all individual participants and their parent or legal guardian included in this study.

Study Sites We are also grateful for the hard work and dedication of the investigators and study teams at each site (Table 7).

Figures

Fig. 1
Fig. 1
Recruitment flow chart
Fig. 2
Fig. 2
Study schema
Fig. 3
Fig. 3
Bar chart showing adherence results
See this image and copyright information in PMC

References

    1. Yeh EA, Waubant E, Krupp LB, Ness J, Chitnis T, Kuntz N, et al. Multiple sclerosis therapies in pediatric patients with refractory multiple sclerosis. Archives of Neurology. 2011;68(4):437–444. doi: 10.1001/archneurol.2010.325. - DOI - PubMed
    1. Thannhauser JE, Mah JK, Metz LM. Adherence of adolescents to multiple sclerosis disease-modifying therapy. Pediatric Neurology. 2009;41(2):119–123. doi: 10.1016/j.pediatrneurol.2009.03.004. - DOI - PubMed
    1. Giovannoni G, Southam E, Waubant E. Systematic review of disease-modifying therapies to assess unmet needs in multiple sclerosis: Tolerability and adherence. Multiple Sclerosis Journal. 2012;18(7):932–946. - PubMed
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    1. Kahana S, Drotar D, Frazier T. Meta-analysis of psychological interventions to promote adherence to treatment in pediatric chronic health conditions. Journal of Pediatric Psychology. 2008;33(6):590–611. - PubMed

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