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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02234713
First Posted: September 9, 2014
Last Update Posted: September 20, 2016
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.
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):
Ann Yeh, The Hospital for Sick Children
  Purpose
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 Intervention
Multiple Sclerosis Behavioral: Motivational Interview Other: Video Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Treatment Adherence in Pediatric Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Ann Yeh, The Hospital for Sick Children:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 71
Study Start Date: January 2013
Study Completion Date: September 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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
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
St. 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
Principal Investigator: E. Ann Yeh, MD University of Toronto, The Hospital for Sick Children
  More Information

Responsible Party: Ann Yeh, Staff Neurologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02234713     History of Changes
Other Study ID Numbers: 1000035924
HC 0148 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
First Submitted: September 5, 2014
First Posted: September 9, 2014
Last Update Posted: September 20, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases