Adherence in Pediatric Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Treatment Adherence in Pediatric Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Motivational Interview
* Other: Video Attention Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioural Intervention/Feedback<br>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<br> <br> |
| Active Comparator: Video Attention Control<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Level of Adherence in Subjects (Objective Measure) | 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. | Baseline, 3 months, 6 months | 
| Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ | 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. | Baseline, 3 months, 6 months | 
| Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky | 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. | Baseline, 3 months, 6 months | 
| Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement | 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. | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL | 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. | Baseline, 3 months, 6 months | 
| Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ | 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. | Baseline, 3 months, 6 months |