Adherence in Pediatric Multiple Sclerosis

Treatment Adherence in Pediatric Multiple Sclerosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02234713

Enrollment

Registered

2014-09-09

Start date

2013-01-31

Completion date

2016-09-30

Last updated

2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

BEHAVIORALMotivational Interview

OTHERVideo Attention Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Level of Adherence in Subjects (Objective Measure)	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.
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ	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.
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky	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.
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement	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

Measure	Time frame	Description
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL	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.
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ	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

Measure	Time frame	Description
Well-Being	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.

Countries

Canada, United States

Participant flow

Pre-assignment details

Participants were assigned to a study arm after completion of the enrollment visit. Thus, any participants who consented but did not complete the enrollment visit were not assigned to a study arm.

Participants by arm

Arm	Count
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. Motivational Interview	25
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. Video Attention Control	27
Total	52

Baseline characteristics

Characteristic	Behavioural Intervention/Feedback	Video Attention Control	Total
Age, Categorical <=18 years	25 Participants	27 Participants	52 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	16.32 years STANDARD_DEVIATION 1.81	15.76 years STANDARD_DEVIATION 2.52	16.03 years STANDARD_DEVIATION 2.2
Race/Ethnicity, Customized Other	13 participants	16 participants	29 participants
Race/Ethnicity, Customized White	12 participants	11 participants	23 participants
Region of Enrollment Canada	13 participants	10 participants	23 participants
Region of Enrollment United States	12 participants	17 participants	29 participants
Sex: Female, Male Female	18 Participants	16 Participants	34 Participants
Sex: Female, Male Male	7 Participants	11 Participants	18 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 25	0 / 27
serious Total, serious adverse events	0 / 25	0 / 27

Outcome results

Primary

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.