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Trial record 1 of 1 for:    NCT02234713
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Adherence in Pediatric Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234713
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Loma Linda University
University of Pittsburgh
Children's Hospital of Philadelphia
Boston Children’s Hospital
Baylor College of Medicine
University of Alabama at Birmingham
Mayo Clinic
University of Colorado, Denver
University of California, San Francisco
Washington University School of Medicine
Alberta Children's Hospital
The Cleveland Clinic
DeltaQuest Foundation
Information provided by (Responsible Party):
E. Ann Yeh, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE September 5, 2014
First Posted Date  ICMJE September 9, 2014
Results First Submitted Date  ICMJE July 3, 2019
Results First Posted Date  ICMJE January 18, 2020
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE January 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Adherence [ Time Frame: baseline to three months & three months to six months ]
Adherence will be estimated pre- and post-intervention by computing the proportion of missed doses to expected doses from baseline to three months (i.e. pre-intervention) and three months to six months (i.e. post-intervention).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Self-Efficacy [ Time Frame: baseline, three months, and six months ]
Self-efficacy scores (MS Self-Efficacy Measure) will be compared at baseline, three months, and six months between the two study arms.
Current Other Pre-specified Outcome Measures
 (submitted: September 8, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Adherence in Pediatric Multiple Sclerosis
Official Title  ICMJE Treatment Adherence in Pediatric Multiple Sclerosis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Behavioral: Motivational Interview
  • Other: Video Attention Control
Study Arms  ICMJE
  • Experimental: Behavioural Intervention/Feedback
    The behavioral interventionist will contact the patient and parent by email and telephone to schedule a telephone call to review the downloaded adherence information and discuss barriers experienced by the patient/parent using a standard script. The behavioral feedback will be administered three times: at 1-, 2- and 3-months post-baseline.
    Intervention: Behavioral: Motivational Interview
  • Active Comparator: Video Attention Control
    The patients in this arm of the study will be emailed a link to an educational video about Pediatric MS and therapy for MS at three time points: 1-, 2-, and 3-months post-baseline.
    Intervention: Other: Video Attention Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2016)
71
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2014)
160
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02234713
Other Study ID Numbers  ICMJE 1000035924
HC 0148 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party E. Ann Yeh, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE
  • National Multiple Sclerosis Society
  • Loma Linda University
  • University of Pittsburgh
  • Children's Hospital of Philadelphia
  • Boston Children’s Hospital
  • Baylor College of Medicine
  • University of Alabama at Birmingham
  • Mayo Clinic
  • University of Colorado, Denver
  • University of California, San Francisco
  • Washington University School of Medicine
  • Alberta Children's Hospital
  • The Cleveland Clinic
  • DeltaQuest Foundation
Investigators  ICMJE
Principal Investigator: E. Ann Yeh, MD University of Toronto, The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP