Adherence in Pediatric Multiple Sclerosis

NCT02234713 | Completed Results

• 2 other identifiers: 1000035924HC 0148
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 13

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline, 3 months, 6 months

Secondary Outcomes (2)

• Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL

  Baseline, 3 months, 6 months

• Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ

  Baseline, 3 months, 6 months

Other Outcomes (1)

• Well-Being

  baseline, three months, and six months

Study Arms (2)

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.

Behavioral: Motivational Interview

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.

Other: Video Attention Control

Interventions

Motivational Interview BEHAVIORAL

Behavioural Intervention/Feedback

Video Attention Control OTHER

Video Attention Control

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• National Multiple Sclerosis Society: collaborator
• Loma Linda University: collaborator
• University of Pittsburgh: collaborator
• Children's Hospital of Philadelphia: collaborator
• Boston Children's Hospital: collaborator
• Baylor College of Medicine: collaborator
• University of Alabama at Birmingham: collaborator
• Mayo Clinic: collaborator
• University of Colorado, Denver: collaborator
• University of California, San Francisco: collaborator
• Washington University School of Medicine: collaborator
• Alberta Children's Hospital: collaborator
• The Cleveland Clinic: collaborator
• DeltaQuest Foundation: collaborator

Study Sites (13)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

The Regents of the University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado at Denver

Denver, Colorado, 80202, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (4)

• 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.

  PMID: 29911511 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. 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.

  PMID: 29274015 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.

  PMID: 28393317 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.

  PMID: 28273780 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Ann Yeh
• Organization: Hospital for Sick Children

ann.yeh@sickkids.ca

416-813-7353

Study Officials

• E. Ann Yeh, MD

  University of Toronto, The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neurologist

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: January 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Locations

US (11); CA (2)