TY - JOUR
T1 - Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth
T2 - results of a randomized trial
AU - On Behalf Of The Pediatric Ms Adherence Study Group
AU - Yeh, E. Ann
AU - Grover, Stephanie A.
AU - Powell, Victoria E.
AU - Alper, Gulay
AU - Banwell, Brenda L.
AU - Edwards, Kim
AU - Gorman, Mark
AU - Graves, Jennifer
AU - Lotze, Timothy E.
AU - Mah, Jean K.
AU - Mednick, Lauren
AU - Ness, Jayne
AU - Obadia, Maya
AU - Slater, Ruth
AU - Waldman, Amy
AU - Waubant, Emmanuelle
AU - Schwartz, Carolyn E.
AU - Aaen, Gregory
AU - Alper, Gulay
AU - Banwell, Brenda L.
AU - Belsole, Charlene
AU - Berenbaum, Tara
AU - Breiner, Petra
AU - Camposano, Susana
AU - Chohan, Hardeep
AU - Darrell, Carolynn
AU - Dowdy, Sarah
AU - Edwards, Kim
AU - Gorman, Mark
AU - Graves, Jennifer
AU - Grayson, La June
AU - Grover, Stephanie A.
AU - Haig, Tiffany
AU - Hamer, Sabrina
AU - Hart, Janace
AU - Jenkins, Kawonas
AU - Lavery, Amy
AU - Liu, Geraldine
AU - Lotze, Timothy
AU - Mahabir, Rory
AU - Mar, Soe
AU - Mednick, Lauren
AU - Mendoza, Elva R.
AU - Moodley, Manikum
AU - Ness, Jayne
AU - Noguera, Austin
AU - Obadia, Maya
AU - Petty, Marvin
AU - Pope, Sarah Planchon
AU - Tillema, Jan Mendelt
N1 - Funding Information:
This work was funded by the National Multiple Sclerosis Society (HC 0148).
Funding Information:
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.
Funding Information:
We are grateful for the involvement of the youth with MS and their parents, as well as to all the investigators and their institutions involved, without whom this study would not have been possible. This work was funded by the National Multiple Sclerosis Society (HC 0148). Gregory Aaen, Gulay Alper, Brenda L. Banwell, Charlene Belsole, Tara Berenbaum, Petra Breiner, Susana Camposano, Hardeep Chohan, Carolynn Darrell, Sarah Dowdy, Kim Edwards, Mark Gorman, Jennifer Graves, La June Grayson, Stephanie A. Grover, Tiffany Haig, Sabrina Hamer, Janace Hart, Kawonas Jenkins, Amy Lavery, Geraldine Liu, Timothy Lotze, Jean K. Mah, Rory Mahabir, Soe Mar, Lauren Mednick, Elva R. Mendoza, Manikum Moodley, Jayne Ness, Austin Noguera, Maya Obadia, Marvin Petty, Sarah Planchon Pope, Daniela Pohl, Mariam Pontifes, Victoria E. Powell, Elizabeth Quon, Mary Rensel, Jennifer Resto, Ian Rossman, Melissa Rundquist, Karla Sanchez, Teri Schreiner, Carolyn E. Schwartz, Ruth Slater, Maleka Smith, Jaime Sorum, Alexander Stein, Marija Stosic, Jan-Mendelt Tillema, Sunita Venkateswaran, Jennifer Vincent, Amy Waldman, Emmanuelle Waubant and E. Ann Yeh. Supporting documentation for our findings is provided in manuscript data and figures and tables. Scientists wishing to gain access to our data may contact the first author (EAY), who will consider such requests on a case-by-case basis, subject to the scientific rigor of the proposed research question. 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.
Publisher Copyright:
© 2017, Springer International Publishing Switzerland.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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.
AB - 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.
KW - Behavioral intervention
KW - Multiple sclerosis
KW - Pediatric
KW - Quality of life
KW - Well-being
UR - http://www.scopus.com/inward/record.url?scp=85017180430&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85017180430&partnerID=8YFLogxK
U2 - 10.1007/s11136-017-1571-z
DO - 10.1007/s11136-017-1571-z
M3 - Article
C2 - 28393317
AN - SCOPUS:85017180430
VL - 26
SP - 2333
EP - 2349
JO - Quality of Life Research
JF - Quality of Life Research
SN - 0962-9343
IS - 9
ER -