E Ann Yeh1,2, Stephanie A Grover3, Victoria E Powell4, Gulay Alper5, Brenda L Banwell6, Kim Edwards7, Mark Gorman8, Jennifer Graves9, Timothy E Lotze10, Jean K Mah11, Lauren Mednick8, Jayne Ness12, Maya Obadia13,14, Ruth Slater7, Amy Waldman6, Emmanuelle Waubant9, Carolyn E Schwartz4,15. 1. 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. 2. Faculty of Medicine, The University of Toronto, 1 King's College Circle #3172, Toronto, ON, M5S 1A8, Canada. ann.yeh@sickkids.ca. 3. 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. 4. DeltaQuest Foundation Inc., 31 Mitchell Road, Concord, MA, 01742, USA. 5. Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, 4401 Penn Avenue, Pittsburgh, PA, 15224, USA. 6. Division of Neurology, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., Philadelphia, PA, 19104, USA. 7. Department of Psychiatry, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G1X8, Canada. 8. Boston Children's Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA, 02115, USA. 9. University of California San Francisco, 505 Parnassus Avenue, San Francisco, CA, 94143, USA. 10. Texas Children's Hospital, Baylor College of Medicine, 6621 Fannin Street, Houston, TX, 77030, USA. 11. Alberta Children's Hospital, 2888 Shanganappi Trail NW, Calgary, AB, T3B 6A8, Canada. 12. University of Alabama at Birmingham, 1720 2nd Avenue, Birmingham, AL, 35294, USA. 13. ELLICSR: Health, Wellness, and Cancer Survivorship Centre, University Health Network, 585 University Avenue, Toronto, ON, M5G 2C4, Canada. 14. Department of Psychology, Faculty of Medicine, University of Toronto, 1 King's College Circle #3172, Toronto, ON, M5S 1A8, Canada. 15. Departments of Medicine and Orthopaedic Surgery, Tufts University Medical School, 800 Washington Street, Boston, MA, 02111, USA.
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.
RCT Entities:
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.
Entities:
Keywords:
Behavioral intervention; Multiple sclerosis; Pediatric; Quality of life; Well-being
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