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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Motivational Interview Other: Video Attention Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Treatment Adherence in Pediatric Multiple Sclerosis
Study Start Date : January 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 Other: Video Attention Control


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234713


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
The Regents of the University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado at Denver
Denver, Colorado, United States, 80202
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63130
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
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
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Principal Investigator: E. Ann Yeh, MD University of Toronto, The Hospital for Sick Children
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: E. Ann Yeh, Staff Neurologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02234713    
Other Study ID Numbers: 1000035924
HC 0148 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
First Posted: September 9, 2014    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases