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Clinical Trials/NCT03137602
NCT03137602
Completed
Not Applicable

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

The Hospital for Sick Children1 site in 1 country14 target enrollmentMarch 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Multiple Sclerosis
Sponsor
The Hospital for Sick Children
Enrollment
14
Locations
1
Primary Endpoint
Utility of the ATOMIC program
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2018
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

E. Ann Yeh

Associate Scientist, Research Institute

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Utility of the ATOMIC program

Time Frame: 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

Time Frame: 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

Study Sites (1)

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