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Completed

NCT Number: NCT02234713

Adherence in Pediatric Multiple Sclerosis

Disease modifying therapies (DMT) are widely used for children and adolescents with MS. Nonetheless, many pediatric patients continue to relapse and therefore require changes in therapy. We designed this research study to learn more about medication use in children and adolescents with MS. We are also interested in learning what a behavioral feedback intervention can tell us about adherence to medicine. Finally, we hope this research project will inform the way we provide clinical care for children and adolescents with MS.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescent boys/girls who are 10 to 17 years 11 months old;
  • Have a diagnosis of MS, as per revised McDonald diagnostic criteria and International Pediatric MS Study Group criteria;
  • Prescribed with an oral or injectable disease-modifying therapy for MS for at least six months.

Exclusion criteria

  • Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities. This is indicative of not having a true diagnosis of MS.
  • Patients on IV DMT will not be included in the study.
  • Non-English speaking patients

Treatment and study plan

Motivational interview

Behavioral

Video Attention Control

Other

Primary outcomes

  1. Change in Level of Adherence in Subjects (Objective Measure)

    Time frame: Baseline, 3 months, 6 months

    Objective measures included: (A) pharmacy refill data provided by site coordinators for 12 months prior to study entry and for 6 months post-study entry and (B) the MEMS cap, an EM device (MEMS, AARDEX) that captures each time the patient discards a needle from their injection or opens their pill bottle. Adherence information from MEMS caps is downloaded and stored on a secured web-platform (medAmigo™). These data were used to compile drug-dosing history data and to calculate medication adherence during the course of the study.

  2. Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ

    Time frame: Baseline, 3 months, 6 months

    Multiple Sclerosis Treatment Adherence Questionnaire (MSTAQ): Assesses missed doses, side effects and barriers of taking DMTs, and behavioral coping strategies used (e.g., icing the injection site, taking pain medication) over the past four weeks. We adapted the MSTAQ to include both oral and injectable medications. We used a standardized scoring algorithm (0-100), where higher scores reflected higher numbers of missed doses, side effects, barriers, or behavioral coping strategies. Subjects completed only the barriers items, and the parent completed all items.

  3. Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky

    Time frame: Baseline, 3 months, 6 months

    Morisky Adherence Scale (Morisky): A widely used 8-item patient-/parent-reported measure with documented reliability and validity. Total scores range from 0 to 8.The following scoring algorithm was used: 8 = high adherence, 6-7 = medium adherence, and <6=low adherence.

  4. Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement

    Time frame: Baseline, 3 months, 6 months

    Parental involvement in DMT administration (Parental Involvement): Percentage of time the parent reported (1) reminding the child to take her/his DMT; (2) being present when the child took her/his DMT; and (3) administering the child's DMT.

Secondary outcomes

  1. Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL

    Time frame: Baseline, 3 months, 6 months

    Pediatric Quality of Life Inventory (PedsQL): A 23-item tool with subscales for physical, social, emotional, and school functioning. The PedsQL has documented reliability and validity, and has been used in a large number of pediatric quality-of-life studies. Subscale scores range from 0 to 100 with higher scores representing better functioning.

  2. Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ

    Time frame: Baseline, 3 months, 6 months

    Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ): Neurocognitive Functioning will be assessed using the informant-report version of the Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ). This 15-item tool has documented high test-retest stability, predictive validity, and construct validity. Informant reports are documented to be reliably correlated with cognitive dysfunction and be less biased by patient depression. Total scores range from 0 to 60 with a higher score indicating worse cognitive functioning.

Other outcomes

  1. Well-Being

    Time frame: baseline, three months, and six months

    Autonomy and Environmental Mastery subscale scores (Ryff Scales of Psychological Well-Being) will be compared at baseline, three months, and six months between the two study arms.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Alberta Children's Hospital
  • Baylor College of Medicine
  • Boston Children's Hospital
  • Children's Hospital of Philadelphia
  • DeltaQuest Foundation
  • Loma Linda University
  • Mayo Clinic
  • National Multiple Sclerosis Society
  • The Cleveland Clinic
  • University of Alabama at Birmingham
  • University of California, San Francisco
  • University of Colorado, Denver
  • University of Pittsburgh
  • Washington University School of Medicine

Registry information

Official study title

Treatment Adherence in Pediatric Multiple Sclerosis

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2014
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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