Adherence in Pediatric Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02234713
• Date of registration: 05/09/2014
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children
• Public title: Adherence in Pediatric Multiple Sclerosis
• Scientific title: Treatment Adherence in Pediatric Multiple Sclerosis
• Date of first enrolment: January 2013
• Target sample size: 71
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02234713
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada, United States

Contacts

• Name: E. Ann Yeh, MD
• Affiliation: University of Toronto, The Hospital for Sick Children

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Behavioral: Motivational Interview

Other: Video Attention Control

Primary Outcome(s)

Change in Level of Adherence in Subjects (Objective Measure) [Time Frame: Baseline, 3 months, 6 months]

Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky [Time Frame: Baseline, 3 months, 6 months]

Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ [Time Frame: Baseline, 3 months, 6 months]

Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement [Time Frame: Baseline, 3 months, 6 months]

Secondary Outcome(s)

Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ [Time Frame: Baseline, 3 months, 6 months]

Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL [Time Frame: Baseline, 3 months, 6 months]

Secondary ID(s)

HC 0148

1000035924

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boston Children's Hospital

Children's Hospital of Philadelphia

The Cleveland Clinic

Washington University School of Medicine

National Multiple Sclerosis Society

University of California, San Francisco

University of Colorado, Denver

Baylor College of Medicine

Loma Linda University

University of Alabama at Birmingham

University of Pittsburgh

Alberta Children's Hospital

DeltaQuest Foundation

Mayo Clinic

Results

• Results available: Yes
• Date Posted: 18/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02234713