跳至主要内容
临床试验/NCT03137602
NCT03137602已完成不适用

ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Utility of the ATOMIC program

研究概览

简要总结

Taking part in recommended levels of physical activity in youth with MS may have an important and positive impact on disease symptoms, long-term disability and health outcomes. Unfortunately, youth with MS are highly inactive. In order to address this issue, the investigators have developed an MS-specific mobile application for teens called Active Teens with Multiple Sclerosis (ATOMIC). In this research the investigators will evaluate the feasibility of using the ATOMIC program in youth with MS. The results of this pilot study will provide the data necessary to ensure the ATOMIC program aligns with the needs of youth with MS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • MS diagnosis following standard definitions (IPMSSG);
  • EDSS <4.0;
  • Ability to speak English.

排除标准

  • Known cardiac disease, including cyanotic congenital heart disease;
  • inability to understand instructions and tolerate proposed testing or vigorous PA.

研究组 & 干预措施

ATOMIC mobile app

Other

The proposed ATOMIC intervention consists of four primary components: (a) one-on-one chats with a PA coach, (b) informational posts, (c) PA self-monitoring through an activity tracker and (d) educational modules regarding different aspects of becoming PA delivered through our MS specific PA app.

干预措施: ATOMIC mobile app (Device)

结局指标

主要结局

Utility of the ATOMIC program

时间窗: Interview [30 minutes] at 12 weeks

Utility will be addressed through semi-structured interviews that includes both open and closed ended questions. The interviews will be used to elicit the perceptions and preferences of the participants surrounding the use and method of delivery of the PA coaching and program content (e.g. phone, text messaging, posts to app); the usefulness, relevance, and applicability of the ATOMIC program content; as well as facilitators and barriers to use of the program. Semi-structured interviews will be conducted at baseline, six weeks, and post-intervention (twelve weeks). To supplement the interview data, utility will also be captured by counting the number of log-ins to the app and the number of completed coaching sessions and modules.

Feasibility of the ATOMIC program

时间窗: Entire study - up to 24 weeks

Determined by calculating accrual rates, drop-out rates, adherence rates with intervention, adverse event rates, proportion of completed study questionnaires, accelerometry and proportion of complete data extraction from ATOMIC app

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

E. Ann Yeh

Associate Scientist, Research Institute

The Hospital for Sick Children

研究点 (2)

Loading locations...

相似试验