title: Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Pediatric MS and Neuroinflammatory Disorders Program, Division of Neurology, Department of Pediatrics, Neuroscience and Mental Health, Hospital for Sick Children Research Institute, Hospital for Sick Children, 555 University Avenue, Rm 6D33, Toronto, ON, M5G1X8, Canada. ann.yeh@sickkids.ca.|Faculty of Medicine, The University of Toronto, 1 King's College Circle #3172, Toronto, ON, M5S 1A8, Canada. ann.yeh@sickkids.ca.
authors.forename: E Ann
authors.initials: EA
authors.lastname: Yeh
authors.affiliation: Pediatric MS and Neuroinflammatory Disorders Program, Division of Neurology, Department of Pediatrics, Neuroscience and Mental Health, Hospital for Sick Children Research Institute, Hospital for Sick Children, 555 University Avenue, Rm 6D33, Toronto, ON, M5G1X8, Canada.
authors.forename: Stephanie A
authors.initials: SA
authors.lastname: Grover
authors.affiliation: DeltaQuest Foundation Inc., 31 Mitchell Road, Concord, MA, 01742, USA.
authors.forename: Victoria E
authors.initials: VE
authors.lastname: Powell
authors.affiliation: Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, 4401 Penn Avenue, Pittsburgh, PA, 15224, USA.
authors.forename: Gulay
authors.initials: G
authors.lastname: Alper
authors.affiliation: Division of Neurology, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., Philadelphia, PA, 19104, USA.
authors.forename: Brenda L
authors.initials: BL
authors.lastname: Banwell
authors.affiliation: Department of Psychiatry, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G1X8, Canada.
authors.forename: Kim
authors.initials: K
authors.lastname: Edwards
authors.affiliation: Boston Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA, 02115, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Gorman
authors.affiliation: University of California San Francisco, 505 Parnassus Avenue, San Francisco, CA, 94143, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Graves
authors.affiliation: Texas Children's Hospital, Baylor College of Medicine, 6621 Fannin Street, Houston, TX, 77030, USA.
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Lotze
authors.affiliation: Alberta Children's Hospital, 2888 Shanganappi Trail NW, Calgary, AB, T3B 6A8, Canada.
authors.forename: Jean K
authors.initials: JK
authors.lastname: Mah
authors.affiliation: Boston Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA, 02115, USA.
authors.forename: Lauren
authors.initials: L
authors.lastname: Mednick
authors.affiliation: University of Alabama at Birmingham, 1720 2nd Avenue, Birmingham, AL, 35294, USA.
authors.forename: Jayne
authors.initials: J
authors.lastname: Ness
authors.affiliation: ELLICSR: Health, Wellness, and Cancer Survivorship Centre, University Health Network, 585 University Avenue, Toronto, ON, M5G 2C4, Canada.|Department of Psychology, Faculty of Medicine, University of Toronto, 1 King's College Circle #3172, Toronto, ON, M5S 1A8, Canada.
authors.forename: Maya
authors.initials: M
authors.lastname: Obadia
authors.affiliation: Department of Psychiatry, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G1X8, Canada.
authors.forename: Ruth
authors.initials: R
authors.lastname: Slater
authors.affiliation: Division of Neurology, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., Philadelphia, PA, 19104, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Waldman
authors.affiliation: University of California San Francisco, 505 Parnassus Avenue, San Francisco, CA, 94143, USA.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Waubant
authors.affiliation: DeltaQuest Foundation Inc., 31 Mitchell Road, Concord, MA, 01742, USA.|Departments of Medicine and Orthopaedic Surgery, Tufts University Medical School, 800 Washington Street, Boston, MA, 02111, USA.
authors.forename: Carolyn E
authors.initials: CE
authors.lastname: Schwartz
mesh_terms: D000293:Adolescent; D005260:Female; D015438:Health Behavior / Q000502:physiology*; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology*; D009103:Multiple Sclerosis / Q000473:pathology; D011788:Quality of Life / Q000523:psychology*
keywords: Behavioral intervention; Multiple sclerosis; Pediatric; Quality of life; Well-being