Adherence in Pediatric Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT02234713|
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Motivational Interview Other: Video Attention Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment Adherence in Pediatric Multiple Sclerosis|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||September 2016|
Experimental: 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.
Behavioral: Motivational Interview
Active Comparator: 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.
Other: Video Attention Control
- Change in Level of Adherence in Subjects (Objective Measure) [ Time Frame: Baseline, 3 months, 6 months ]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 [ Time Frame: Baseline, 3 months, 6 months ]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 [ Time Frame: Baseline, 3 months, 6 months ]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 [ Time Frame: Baseline, 3 months, 6 months ]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.
- Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL [ Time Frame: Baseline, 3 months, 6 months ]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 [ Time Frame: Baseline, 3 months, 6 months ]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.
- Well-Being [ Time Frame: baseline, three months, and six months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234713
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Loma Linda University|
|Loma Linda, California, United States, 92354|
|The Regents of the University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, Colorado|
|University of Colorado at Denver|
|Denver, Colorado, United States, 80202|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63130|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Alberta Children's Hospital|
|Calgary, Alberta, Canada, T3B 6A8|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||E. Ann Yeh, MD||University of Toronto, The Hospital for Sick Children|