Adherence in Pediatric Multiple Sclerosis

The Hospital for Sick Children

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Video Attention Control; Behavioral: Motivational Interview

Study type: Interventional

Funder types: Other

Identifiers

NCT02234713

1000035924

HC 0148 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Behavioural Intervention/Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Interview

Video Attention Control

Active Comparator group

Description:

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.

Treatment:

Other: Video Attention Control