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Trial record 1 of 1 for:    NCT02234713
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Adherence in Pediatric Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234713
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Loma Linda University
University of Pittsburgh
Children's Hospital of Philadelphia
Boston Children’s Hospital
Baylor College of Medicine
University of Alabama at Birmingham
Mayo Clinic
University of Colorado, Denver
University of California, San Francisco
Washington University School of Medicine
Alberta Children's Hospital
The Cleveland Clinic
DeltaQuest Foundation
Information provided by (Responsible Party):
E. Ann Yeh, The Hospital for Sick Children

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Multiple Sclerosis
Interventions Behavioral: Motivational Interview
Other: Video Attention Control
Enrollment 71
Recruitment Details  
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.
Arm/Group Title Behavioural Intervention/Feedback Video Attention Control
Hide Arm/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.

Motivational Interview

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

Period Title: Overall Study
Started 31 32
Completed 25 27
Not Completed 6 5
Arm/Group Title Behavioural Intervention/Feedback Video Attention Control Total
Hide Arm/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.

Motivational Interview

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 of all reporting groups
Overall Number of Baseline Participants 25 27 52
Hide Baseline Analysis Population Description
Analysis population included those participating the full trial (had two or three time points)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
<=18 years
25
 100.0%
27
 100.0%
52
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 52 participants
16.32  (1.81) 15.76  (2.52) 16.03  (2.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Female
18
  72.0%
16
  59.3%
34
  65.4%
Male
7
  28.0%
11
  40.7%
18
  34.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
White 12 11 23
Other 13 16 29
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Canada 13 10 23
United States 12 17 29
1.Primary Outcome
Title Change in Level of Adherence in Subjects (Objective Measure)
Hide Description 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.
Time Frame Baseline, 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)
Arm/Group Title Baseline 3-month Follow up 6-month Follow up
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 51 52 49
Mean (Standard Deviation)
Unit of Measure: Proportion of doses (actual vs expected)
Pharmacy refill adherence Number Analyzed 51 participants 52 participants 49 participants
0.95  (0.12) 0.86  (0.20) 0.85  (0.22)
MEMs cap adherence Number Analyzed 46 participants 47 participants 45 participants
0.81  (0.22) 0.82  (0.18) 0.66  (0.32)
2.Primary Outcome
Title Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
Hide Description 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.
Time Frame Baseline, 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)
Arm/Group Title Baseline 3-month Follow up 6-month Follow up
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 47 45 47
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Parent MSTAQ missed doses Number Analyzed 47 participants 45 participants 47 participants
0.06  (0.18) 0.07  (0.19) 0.07  (0.22)
Parent MSTAQ behavioural coping strategies Number Analyzed 35 participants 33 participants 34 participants
49.64  (9.58) 49.24  (8.28) 49.33  (10.76)
Parent MSTAQ side effects Number Analyzed 37 participants 34 participants 35 participants
50.03  (9.63) 49.48  (9.58) 49.04  (10.63)
Parent MSTAQ barriers Number Analyzed 47 participants 41 participants 46 participants
50.12  (10.42) 48.66  (8.60) 49.31  (9.74)
Patient MSTAQ barriers Number Analyzed 45 participants 41 participants 46 participants
48.88  (9.22) 50.40  (9.57) 50.09  (10.90)
3.Primary Outcome
Title Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
Hide Description 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.
Time Frame Baseline, 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)
Arm/Group Title Baseline 3-month Follow up 6-month Follow up
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 52 48 49
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Parent Morisky Number Analyzed 49 participants 47 participants 49 participants
6.28  (1.46) 6.40  (1.50) 6.20  (1.85)
Patient Morisky Number Analyzed 52 participants 48 participants 49 participants
5.93  (1.74) 6.00  (1.82) 5.94  (1.91)
4.Primary Outcome
Title Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
Hide Description 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.
Time Frame Baseline, 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)
Arm/Group Title Baseline 3-month Follow up 6-month Follow up
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 51 48 49
Mean (Standard Deviation)
Unit of Measure: Percentage of time
Parent remind 44.61  (38.83) 37.50  (37.90) 33.16  (34.76)
Parent present 65.20  (37.11) 55.21  (39.26) 57.14  (39.53)
Parent administer 36.27  (41.33) 32.81  (41.95) 30.10  (40.82)
5.Secondary Outcome
Title Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
Hide Description 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.
Time Frame Baseline, 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed may differ from the overall number analyzed when not all participants completed each measure.
Arm/Group Title Baseline 3-month Follow up 6-month Follow up
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 52 48 49
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Parent: PedsQL physical functioning Number Analyzed 51 participants 48 participants 49 participants
80.39  (22.32) 76.69  (24.60) 80.93  (21.34)
Parent: PedsQL emotional functioning Number Analyzed 51 participants 48 participants 49 participants
73.04  (21.61) 73.23  (19.03) 72.30  (20.09)
Parent: PedsQL social functioning Number Analyzed 51 participants 48 participants 49 participants
82.35  (18.56) 84.27  (17.74) 84.72  (20.06)
Parent: PedsQL school functioning Number Analyzed 51 participants 48 participants 49 participants
68.24  (16.27) 68.13  (18.24) 68.27  (19.75)
Patient: PedsQL physical functioning Number Analyzed 52 participants 48 participants 49 participants
82.23  (17.85) 81.51  (15.95) 79.21  (20.64)
Patient: PedsQL emotional functioning Number Analyzed 52 participants 47 participants 49 participants
71.15  (20.52) 69.57  (21.44) 66.63  (20.50)
Patient: PedsQL social functioning Number Analyzed 52 participants 48 participants 49 participants
83.56  (15.85) 80.63  (19.34) 82.65  (20.36)
6.Secondary Outcome
Title Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ
Hide Description 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.
Time Frame Baseline, 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed may differ from the overall number analyzed when not all participants completed each measure.
Arm/Group Title Baseline 3-month Follow up 6-month Follow up
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 47 49
Mean (Standard Deviation)
Unit of Measure: Score on a scale
17.90  (13.42) 17.55  (12.41) 20.24  (14.60)
7.Other Pre-specified Outcome
Title Well-Being
Hide Description 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.
Time Frame baseline, three months, and six months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioural Intervention/Feedback Video Attention Control
Hide Arm/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.

Motivational Interview

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

All-Cause Mortality
Behavioural Intervention/Feedback Video Attention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Behavioural Intervention/Feedback Video Attention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavioural Intervention/Feedback Video Attention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ann Yeh
Organization: Hospital for Sick Children
Phone: 416-813-7353 ext 207353
EMail: ann.yeh@sickkids.ca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: E. Ann Yeh, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02234713    
Other Study ID Numbers: 1000035924
HC 0148 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
First Submitted: September 5, 2014
First Posted: September 9, 2014
Results First Submitted: July 3, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020