Treatment Adherence in Pediatric Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 26
- 主要终点
- Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ
时间窗: 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
时间窗: 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
时间窗: 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.
Change in Level of Adherence in Subjects (Objective Measure)
时间窗: 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.
次要结局
- 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)
研究者
E. Ann Yeh
Staff Neurologist
The Hospital for Sick Children