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Adherence in Pediatric Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Motivational Interview
Video Attention Control
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama
  • Loma Linda University
  • The Regents of the University of California, San Francisco
  • University of Colorado at Denver
  • Boston Children's Hospital
  • Mayo Clinic
  • Washington University
  • Cleveland Clinic
  • The Children's Hospital of Philadelphia
  • University of Pittsburgh
  • Baylor College of Medicine
  • Alberta Children's Hospital
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioural Intervention/Feedback

Video Attention Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 5, 2014
Last Updated
January 8, 2020
Sponsor
The Hospital for Sick Children
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
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1. Study Identification

Unique Protocol Identification Number
NCT02234713
Brief Title
Adherence in Pediatric Multiple Sclerosis
Official Title
Treatment Adherence in Pediatric Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioural Intervention/Feedback
Arm Type
Experimental
Arm 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.
Arm Title
Video Attention Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview
Intervention Type
Other
Intervention Name(s)
Video Attention Control
Primary Outcome Measure Information:
Title
Change in Level of Adherence in Subjects (Objective Measure)
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
Title
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
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
Title
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
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
Title
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
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
Secondary Outcome Measure Information:
Title
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
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
Title
Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ
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
Other Pre-specified Outcome Measures:
Title
Well-Being
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Ann Yeh, MD
Organizational Affiliation
University of Toronto, The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
The Regents of the University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado at Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29911511
Citation
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 Reference
derived
PubMed Identifier
29274015
Citation
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.
Results Reference
derived
PubMed Identifier
28393317
Citation
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. Erratum In: Qual Life Res. 2017 Dec 23;:
Results Reference
derived
PubMed Identifier
28273780
Citation
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.
Results Reference
derived

Learn more about this trial

Adherence in Pediatric Multiple Sclerosis

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