Trial Outcomes & Findings for Adherence in Pediatric Multiple Sclerosis (NCT NCT02234713)
NCT ID: NCT02234713
Last Updated: 2020-01-18
Results Overview
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.
COMPLETED
NA
71 participants
Baseline, 3 months, 6 months
2020-01-18
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adherence in Pediatric Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Behavioural Intervention/Feedback
n=25 Participants
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
|
Video Attention Control
n=27 Participants
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
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.32 years
STANDARD_DEVIATION 1.81 • n=5 Participants
|
15.76 years
STANDARD_DEVIATION 2.52 • n=7 Participants
|
16.03 years
STANDARD_DEVIATION 2.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
17 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 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.
Outcome measures
| Measure |
Baseline
n=51 Participants
|
3-month Follow up
n=52 Participants
|
6-month Follow up
n=49 Participants
|
|---|---|---|---|
|
Change in Level of Adherence in Subjects (Objective Measure)
Pharmacy refill adherence
|
0.95 Proportion of doses (actual vs expected)
Standard Deviation 0.12
|
0.86 Proportion of doses (actual vs expected)
Standard Deviation 0.20
|
0.85 Proportion of doses (actual vs expected)
Standard Deviation 0.22
|
|
Change in Level of Adherence in Subjects (Objective Measure)
MEMs cap adherence
|
0.81 Proportion of doses (actual vs expected)
Standard Deviation 0.22
|
0.82 Proportion of doses (actual vs expected)
Standard Deviation 0.18
|
0.66 Proportion of doses (actual vs expected)
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 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.
Outcome measures
| Measure |
Baseline
n=47 Participants
|
3-month Follow up
n=45 Participants
|
6-month Follow up
n=47 Participants
|
|---|---|---|---|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Parent MSTAQ missed doses
|
0.06 Score on a scale
Standard Deviation 0.18
|
0.07 Score on a scale
Standard Deviation 0.19
|
0.07 Score on a scale
Standard Deviation 0.22
|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Parent MSTAQ behavioural coping strategies
|
49.64 Score on a scale
Standard Deviation 9.58
|
49.24 Score on a scale
Standard Deviation 8.28
|
49.33 Score on a scale
Standard Deviation 10.76
|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Parent MSTAQ side effects
|
50.03 Score on a scale
Standard Deviation 9.63
|
49.48 Score on a scale
Standard Deviation 9.58
|
49.04 Score on a scale
Standard Deviation 10.63
|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Parent MSTAQ barriers
|
50.12 Score on a scale
Standard Deviation 10.42
|
48.66 Score on a scale
Standard Deviation 8.60
|
49.31 Score on a scale
Standard Deviation 9.74
|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Patient MSTAQ barriers
|
48.88 Score on a scale
Standard Deviation 9.22
|
50.40 Score on a scale
Standard Deviation 9.57
|
50.09 Score on a scale
Standard Deviation 10.90
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 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.
Outcome measures
| Measure |
Baseline
n=52 Participants
|
3-month Follow up
n=48 Participants
|
6-month Follow up
n=49 Participants
|
|---|---|---|---|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
Parent Morisky
|
6.28 Score on a scale
Standard Deviation 1.46
|
6.40 Score on a scale
Standard Deviation 1.50
|
6.20 Score on a scale
Standard Deviation 1.85
|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
Patient Morisky
|
5.93 Score on a scale
Standard Deviation 1.74
|
6.00 Score on a scale
Standard Deviation 1.82
|
5.94 Score on a scale
Standard Deviation 1.91
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 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.
Outcome measures
| Measure |
Baseline
n=51 Participants
|
3-month Follow up
n=48 Participants
|
6-month Follow up
n=49 Participants
|
|---|---|---|---|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
Parent remind
|
44.61 Percentage of time
Standard Deviation 38.83
|
37.50 Percentage of time
Standard Deviation 37.90
|
33.16 Percentage of time
Standard Deviation 34.76
|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
Parent present
|
65.20 Percentage of time
Standard Deviation 37.11
|
55.21 Percentage of time
Standard Deviation 39.26
|
57.14 Percentage of time
Standard Deviation 39.53
|
|
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
Parent administer
|
36.27 Percentage of time
Standard Deviation 41.33
|
32.81 Percentage of time
Standard Deviation 41.95
|
30.10 Percentage of time
Standard Deviation 40.82
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: The number analyzed may differ from the overall number analyzed when not all participants completed each measure.
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.
Outcome measures
| Measure |
Baseline
n=52 Participants
|
3-month Follow up
n=48 Participants
|
6-month Follow up
n=49 Participants
|
|---|---|---|---|
|
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Parent: PedsQL physical functioning
|
80.39 Score on a scale
Standard Deviation 22.32
|
76.69 Score on a scale
Standard Deviation 24.60
|
80.93 Score on a scale
Standard Deviation 21.34
|
|
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Parent: PedsQL emotional functioning
|
73.04 Score on a scale
Standard Deviation 21.61
|
73.23 Score on a scale
Standard Deviation 19.03
|
72.30 Score on a scale
Standard Deviation 20.09
|
|
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Parent: PedsQL social functioning
|
82.35 Score on a scale
Standard Deviation 18.56
|
84.27 Score on a scale
Standard Deviation 17.74
|
84.72 Score on a scale
Standard Deviation 20.06
|
|
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Parent: PedsQL school functioning
|
68.24 Score on a scale
Standard Deviation 16.27
|
68.13 Score on a scale
Standard Deviation 18.24
|
68.27 Score on a scale
Standard Deviation 19.75
|
|
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Patient: PedsQL physical functioning
|
82.23 Score on a scale
Standard Deviation 17.85
|
81.51 Score on a scale
Standard Deviation 15.95
|
79.21 Score on a scale
Standard Deviation 20.64
|
|
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Patient: PedsQL emotional functioning
|
71.15 Score on a scale
Standard Deviation 20.52
|
69.57 Score on a scale
Standard Deviation 21.44
|
66.63 Score on a scale
Standard Deviation 20.50
|
|
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Patient: PedsQL social functioning
|
83.56 Score on a scale
Standard Deviation 15.85
|
80.63 Score on a scale
Standard Deviation 19.34
|
82.65 Score on a scale
Standard Deviation 20.36
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: The number analyzed may differ from the overall number analyzed when not all participants completed each measure.
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.
Outcome measures
| Measure |
Baseline
n=49 Participants
|
3-month Follow up
n=47 Participants
|
6-month Follow up
n=49 Participants
|
|---|---|---|---|
|
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ
|
17.90 Score on a scale
Standard Deviation 13.42
|
17.55 Score on a scale
Standard Deviation 12.41
|
20.24 Score on a scale
Standard Deviation 14.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, three months, and six monthsAutonomy 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.
Outcome measures
Outcome data not reported
Adverse Events
Behavioural Intervention/Feedback
Video Attention Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place