Adherence in Pediatric Multiple Sclerosis
Treatment Adherence in Pediatric Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Motivational Interview
Compared with
- Video Attention Control
Results by group
Change in Level of Adherence in Subjects (Objective Measure)
Baseline, 3 months, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Baseline | 0.95 Proportion of doses (actual vs expected) | 0.12 (Standard Deviation) | 51 |
| 3-month Follow up | 0.86 Proportion of doses (actual vs expected) | 0.2 (Standard Deviation) | 52 |
| 6-month Follow up | 0.85 Proportion of doses (actual vs expected) | 0.22 (Standard Deviation) | 49 |
| Baseline | 0.81 Proportion of doses (actual vs expected) | 0.22 (Standard Deviation) | 51 |
| 3-month Follow up | 0.82 Proportion of doses (actual vs expected) | 0.18 (Standard Deviation) | 52 |
| 6-month Follow up | 0.66 Proportion of doses (actual vs expected) | 0.32 (Standard Deviation) | 49 |
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Baseline, 3 months, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Baseline | 0.06 Score on a scale | 0.18 (Standard Deviation) | 47 |
| 3-month Follow up | 0.07 Score on a scale | 0.19 (Standard Deviation) | 45 |
| 6-month Follow up | 0.07 Score on a scale | 0.22 (Standard Deviation) | 47 |
| Baseline | 49.64 Score on a scale | 9.58 (Standard Deviation) | 47 |
| 3-month Follow up | 49.24 Score on a scale | 8.28 (Standard Deviation) | 45 |
| 6-month Follow up | 49.33 Score on a scale | 10.76 (Standard Deviation) | 47 |
| Baseline | 50.03 Score on a scale | 9.63 (Standard Deviation) | 47 |
| 3-month Follow up | 49.48 Score on a scale | 9.58 (Standard Deviation) | 45 |
| 6-month Follow up | 49.04 Score on a scale | 10.63 (Standard Deviation) | 47 |
| Baseline | 50.12 Score on a scale | 10.42 (Standard Deviation) | 47 |
| 3-month Follow up | 48.66 Score on a scale | 8.6 (Standard Deviation) | 45 |
| 6-month Follow up | 49.31 Score on a scale | 9.74 (Standard Deviation) | 47 |
| Baseline | 48.88 Score on a scale | 9.22 (Standard Deviation) | 47 |
| 3-month Follow up | 50.40 Score on a scale | 9.57 (Standard Deviation) | 45 |
| 6-month Follow up | 50.09 Score on a scale | 10.9 (Standard Deviation) | 47 |
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
Baseline, 3 months, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Baseline | 6.28 Score on a scale | 1.46 (Standard Deviation) | 52 |
| 3-month Follow up | 6.40 Score on a scale | 1.5 (Standard Deviation) | 48 |
| 6-month Follow up | 6.20 Score on a scale | 1.85 (Standard Deviation) | 49 |
| Baseline | 5.93 Score on a scale | 1.74 (Standard Deviation) | 52 |
| 3-month Follow up | 6.00 Score on a scale | 1.82 (Standard Deviation) | 48 |
| 6-month Follow up | 5.94 Score on a scale | 1.91 (Standard Deviation) | 49 |
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
Baseline, 3 months, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Baseline | 44.61 Percentage of time | 38.83 (Standard Deviation) | 51 |
| 3-month Follow up | 37.50 Percentage of time | 37.9 (Standard Deviation) | 48 |
| 6-month Follow up | 33.16 Percentage of time | 34.76 (Standard Deviation) | 49 |
| Baseline | 65.20 Percentage of time | 37.11 (Standard Deviation) | 51 |
| 3-month Follow up | 55.21 Percentage of time | 39.26 (Standard Deviation) | 48 |
| 6-month Follow up | 57.14 Percentage of time | 39.53 (Standard Deviation) | 49 |
| Baseline | 36.27 Percentage of time | 41.33 (Standard Deviation) | 51 |
| 3-month Follow up | 32.81 Percentage of time | 41.95 (Standard Deviation) | 48 |
| 6-month Follow up | 30.10 Percentage of time | 40.82 (Standard Deviation) | 49 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Behavioural Intervention/Feedback | 25 | 0 (0.0%) | |
| Video Attention Control | 27 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Level of Adherence in Subjects (Objective Measure)
Baseline, 3 months, 6 months
Quality of life (reported by participants)Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Baseline, 3 months, 6 months
PainQuality of life (reported by participants)SafetyChange in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
Baseline, 3 months, 6 months
Quality of life (reported by participants)Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
Baseline, 3 months, 6 months
Quality of life (reported by participants)
Other measures (2)
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Baseline, 3 months, 6 months
Quality of life (reported by participants)Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ
Baseline, 3 months, 6 months
Thinking and memoryMood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified) · 10 to 18
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Yeh EA, Chiang N, Darshan B, Nejati N, Grover SA, Schwartz CE, Slater R, Finlayson M; Pediatric MS Adherence Study Group. Adherence in Youth With Multiple Sclerosis: A Qualitative Assessment of Habit Formation, Barriers, and Facilitators. Qual Health Res. 2019 Apr;29(5):645-657. doi: 10.1177/1049732318779039. Epub 2018 Jun 17.Results
Yeh EA, Grover SA, Powell VE, Alper G, Banwell BL, Edwards K, Gorman M, Graves J, Lotze TE, Mah JK, Mednick L, Ness J, Obadia M, Slater R, Waldman A, Waubant E, Schwartz CE; Pediatric MS Adherence Study Group. Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial. Qual Life Res. 2018 ApResults
Yeh EA, Grover SA, Powell VE, Alper G, Banwell BL, Edwards K, Gorman M, Graves J, Lotze TE, Mah JK, Mednick L, Ness J, Obadia M, Slater R, Waldman A, Waubant E, Schwartz CE; Pediatric MS Adherence Study Group. Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial. Qual Life Res. 2017 Sep;26(9):2333-234Results
Schwartz CE, Grover SA, Powell VE, Noguera A, Mah JK, Mar S, Mednick L, Banwell BL, Alper G, Rensel M, Gorman M, Waldman A, Schreiner T, Waubant E, Yeh EA. Risk factors for non-adherence to disease-modifying therapy in pediatric multiple sclerosis. Mult Scler. 2018 Feb;24(2):175-185. doi: 10.1177/1352458517695469. Epub 2017 Feb 1.
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History
Started
Jan 2013
Main results due
Jul 2016
Finished
Sept 2016
Results posted
Jan 2020