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

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A Correction to this article was published on 23 December 2017

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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.

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Change history

  • 23 December 2017

    The clinicaltrials.gov identifying number for the article titled “Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial” is NCT02234713 (https://clinicaltrials.gov/ct2/show/NCT02234713).

Abbreviations

DMT:

Disease-modifying therapy

EM:

Electronic monitoring

MI:

Motivational interviewing

MS:

Multiple sclerosis

MSSE:

MS Self-Efficacy Scale

MSTAQ:

Multiple Sclerosis Treatment Adherence Questionnaire

PedsQL:

Pediatric Quality of Life Inventory

SD:

Standard deviation

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Acknowledgements

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.

Funding

This work was funded by the National Multiple Sclerosis Society (HC 0148).

Pediatric MS Adherence Study Group

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.

Availability of data and supporting materials

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.

Author information

Authors and Affiliations

  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

    E. Ann Yeh & Stephanie A. Grover

  2. Faculty of Medicine, The University of Toronto, 1 King’s College Circle #3172, Toronto, ON, M5S 1A8, Canada

    E. Ann Yeh

  3. DeltaQuest Foundation Inc., 31 Mitchell Road, Concord, MA, 01742, USA

    Victoria E. Powell & Carolyn E. Schwartz

  4. Children’s Hospital of Pittsburgh, University of Pittsburgh School of Medicine, 4401 Penn Avenue, Pittsburgh, PA, 15224, USA

    Gulay Alper

  5. Division of Neurology, Children’s Hospital of Philadelphia, 3401 Civic Center Blvd., Philadelphia, PA, 19104, USA

    Brenda L. Banwell & Amy Waldman

  6. Department of Psychiatry, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G1X8, Canada

    Kim Edwards & Ruth Slater

  7. Boston Children’s Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA, 02115, USA

    Mark Gorman & Lauren Mednick

  8. University of California San Francisco, 505 Parnassus Avenue, San Francisco, CA, 94143, USA

    Jennifer Graves & Emmanuelle Waubant

  9. Texas Children’s Hospital, Baylor College of Medicine, 6621 Fannin Street, Houston, TX, 77030, USA

    Timothy E. Lotze

  10. Alberta Children’s Hospital, 2888 Shanganappi Trail NW, Calgary, AB, T3B 6A8, Canada

    Jean K. Mah

  11. University of Alabama at Birmingham, 1720 2nd Avenue, Birmingham, AL, 35294, USA

    Jayne Ness

  12. ELLICSR: Health, Wellness, and Cancer Survivorship Centre, University Health Network, 585 University Avenue, Toronto, ON, M5G 2C4, Canada

    Maya Obadia

  13. Department of Psychology, Faculty of Medicine, University of Toronto, 1 King’s College Circle #3172, Toronto, ON, M5S 1A8, Canada

    Maya Obadia

  14. Departments of Medicine and Orthopaedic Surgery, Tufts University Medical School, 800 Washington Street, Boston, MA, 02111, USA

    Carolyn E. Schwartz

Authors
  1. E. Ann Yeh
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  2. Stephanie A. Grover
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  3. Victoria E. Powell
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  7. Mark Gorman
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  8. Jennifer Graves
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  10. Jean K. Mah
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  11. Lauren Mednick
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  12. Jayne Ness
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  13. Maya Obadia
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  14. Ruth Slater
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  15. Amy Waldman
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  16. Emmanuelle Waubant
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Consortia

on behalf of the Pediatric MS Adherence Study Group

  • 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
  •  & E. Ann Yeh

Corresponding author

Correspondence to E. Ann Yeh.

Ethics declarations

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).

Table 7 Site investigators and study coordinators
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Yeh, E., Grover, S.A., Powell, V.E. et al. Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial. Qual Life Res 26, 2333–2349 (2017). https://doi.org/10.1007/s11136-017-1571-z

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