Adherence in Pediatric Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Treatment Adherence in Pediatric Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234713
• Other study ID #: 1000035924
• Secondary ID: HC 0148
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: September 2016

Study information

• Verified date: January 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Motivational Interview

Other:
• Video Attention Control

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	University of Alabama	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Colorado at Denver	Denver	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	Loma Linda University	Loma Linda	California
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	The Regents of the University of California, San Francisco	San Francisco	California

Sponsors (15)

Lead Sponsor

Collaborator

The Hospital for Sick Children

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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.	Baseline, 3 months, 6 months
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.	Baseline, 3 months, 6 months
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.	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.	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.	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.	Baseline, 3 months, 6 months