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

Not Applicable

Completed

• Conditions: Pediatric Multiple Sclerosis
• Interventions: Device: ATOMIC mobile app

• Registration Number: NCT03137602
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-03
• Study Start: 2018-03-07
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ATOMIC mobile app	ATOMIC mobile app	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.

Primary Outcome Measures

Name	Time	Method
Utility of the ATOMIC program	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	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

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada