Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: Results of a randomized trial (P1.379)

Objective: We report the results of a randomized controlled trial using an electronic monitoring device plus a motivational interviewing (MI) informed intervention to enhance adherence to disease-modifying therapies (DMT) in pediatric MS. Background: Interventions to improve medication adherence have not been evaluated in youth with MS. Design/Methods: 52 youth with MS (16.03±2.2 years) from 9 pediatric MS centers were randomized to receive either MI (n=25) (target intervention) or a MS medication video (n=27) (attention control). Objective (“MEMs cap”, pharmacy refill) and self-report measures of adherence and quality of life were collected at baseline, three and six months from 9 Pediatric MS centers. 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-effects models revealed that the MI group decreased their MEMS cap adherence (GroupxTime interaction=−0.19), while increasing frequency of parental DMT reminder (26.01)/administration (11.69). Effect size analysis (ES) revealed decreased MEMS 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, 6 months). We found increases in self-reported adherence (d=0.21) at 3 but not 6 months, and fewer self-reported barriers to adherence at three (d=−0.58) and six months (d=−0.31) in intervention vs. control. MI subjects reported better physical (d=0.23 (3 months), d=0.45(6 months)), emotional (d=0.25, 3 months) and self-efficacy function (d=0.55 (3 months), 0.48 (6 months)), but worse well-being including self-acceptance (d=−0.53 6 months) and environmental mastery (d=−0.42, 3 and 6 months) as compared to control patients. Conclusions: We found increases in self-reported adherence, pharmacy refills, quality of life, and self-efficacy, but decreases in MEMS cap adherence, and worse well-being (self-acceptance/mastery) after the use of MI for medication adherence in youth with MS. Study Supported by: NMSS (HC 0148) Disclosure: Dr. Yeh has nothing to disclose. Dr. Grover has nothing to disclose. Dr. Powell has nothing to disclose. Dr. Noguera has nothing to disclose. Dr. Edwards has nothing to disclose. Dr. Slater has nothing to disclose. Dr. Banwell has received personal compensation for activities with Novartis. Dr. Banwell has received personal compensation in an editorial capacity for Multiple Sclerosis and Related Disorders. Dr. Gorman has nothing to disclose. Dr. Graves has received research support from Genentech, Biogen and S3 Group. Dr. Lotze has nothing to disclose. Dr. Mah has received research support from Biogen, Sanofi-Genzyme, and Novartis. Dr. Mednick has nothing to disclose. Dr. Ness has received research support from Novartis Pharmaceuticals. Dr. Schreiner has received personal compensation for activities with Genentech and MSAA as a consultant. Dr. Waldman has received royalty payments from UpToDate. Dr. Waubant has received research support from Roche, Biogen Idec and Novartis. Dr. Schwartz has nothing to disclose.