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| ID | Type | Description | Link |
|---|---|---|---|
| HC 0148 | Other Grant/Funding Number | National Multiple Sclerosis Society |
Not provided
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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
| Loma Linda University | OTHER |
| University of Pittsburgh | OTHER |
| Children's Hospital of Philadelphia |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioural Intervention/Feedback | Experimental | 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. |
|
| Video Attention Control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interview | Behavioral |
| ||
| Video Attention Control |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Well-Being | 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. | baseline, three months, and six months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E. Ann Yeh, MD | University of Toronto, The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Loma Linda University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29911511 | Derived | 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. | |
| 29274015 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included those participating the full trial (had two or three time points)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months) | Posted | Mean | Standard Deviation | Proportion of doses (actual vs expected) | Baseline, 3 months, 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann Yeh | Hospital for Sick Children | 416-813-7353 | 207353 | ann.yeh@sickkids.ca |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| OTHER |
| Boston Children's Hospital | OTHER |
| Baylor College of Medicine | OTHER |
| University of Alabama at Birmingham | OTHER |
| Mayo Clinic | OTHER |
| University of Colorado, Denver | OTHER |
| University of California, San Francisco | OTHER |
| Washington University School of Medicine | OTHER |
| Alberta Children's Hospital | OTHER |
| The Cleveland Clinic | OTHER |
| DeltaQuest Foundation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
| Other |
|
| Baseline, 3 months, 6 months |
| 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 |
| Loma Linda |
| California |
| 92354 |
| United States |
| The Regents of the University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado at Denver | Denver | Colorado | 80202 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| 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 Apr;27(4):1117. doi: 10.1007/s11136-017-1773-4. |
| 28393317 | Derived | 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):2333-2349. doi: 10.1007/s11136-017-1571-z. Epub 2017 Apr 9. |
| 28273780 | Derived | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 3-month Follow up |
| OG002 | 6-month Follow up |
|
|
| Primary | 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. | Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months) | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | 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. | The number analyzed may differ from the overall number analyzed when not all participants completed each measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 months, 6 months |
|
|
|
| Other Pre-specified | Well-Being | 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. | Not Posted | baseline, three months, and six months | Participants |
| Primary | 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. | Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months) | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 months, 6 months |
|
|
|
| Primary | 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. | Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months) | Posted | Mean | Standard Deviation | Percentage of time | Baseline, 3 months, 6 months |
|
|
|
| Secondary | 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. | The number analyzed may differ from the overall number analyzed when not all participants completed each measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 months, 6 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 27 | 0 | 27 |
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Parent MSTAQ behavioural coping strategies |
|
|
| Parent MSTAQ side effects |
|
|
| Parent MSTAQ barriers |
|
|
| Patient MSTAQ barriers |
|
|
| Parent: PedsQL emotional functioning |
|
|
| Parent: PedsQL social functioning |
|
|
| Parent: PedsQL school functioning |
|
|
| Patient: PedsQL physical functioning |
|
|
| Patient: PedsQL emotional functioning |
|
|
| Patient: PedsQL social functioning |
|
|
| Patient Morisky |
|
|
|
| Parent administer |
|