Clinical trial NCT02234713: Adherence in Pediatric Multiple Sclerosis
Official title: Treatment Adherence in Pediatric Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: Loma Linda University
name: University of Pittsburgh
name: Children's Hospital of Philadelphia
name: Boston Children's Hospital
name: Baylor College of Medicine
name: University of Alabama at Birmingham
name: Mayo Clinic
name: University of Colorado, Denver
name: University of California, San Francisco
name: Washington University School of Medicine
name: Alberta Children's Hospital
name: The Cleveland Clinic
name: DeltaQuest Foundation
First posted: 2014-09-09
Enrollment: 71
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in Level of Adherence in Subjects (Objective Measure)
timeFrame: Baseline, 3 months, 6 months
measure: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
timeFrame: Baseline, 3 months, 6 months
measure: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky
timeFrame: Baseline, 3 months, 6 months
measure: Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL
timeFrame: Baseline, 3 months, 6 months
measure: Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Well-Being
timeFrame: baseline, three months, and six months
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: San Francisco
country: United States
facility: The Regents of the University of California, San Francisco
state: California
city: Denver
country: United States
facility: University of Colorado at Denver
state: Colorado
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: University of Toronto, The Hospital for Sick Children
name: E. Ann Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.