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Completed

NCT Number: NCT03137602

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

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.

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Key information

Conditions

Pediatric Multiple Sclerosis

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATOMIC mobile app

Device

(a) PA Coach, One-on-one Chats. Coaches will conduct three one-on-one phone or video conferencing sessions and will also conduct a text messaging session once per week to reinforce and follow-up on the one-on-one phone sessions during the course of the intervention. (b) PA-Self Monitoring. An activity tracker (Fitbit Charge 2) will be used to allow participants to monitor their activity behaviors (e.g. step counts). (c) PA Information. In addition the coach will send weekly tailored PA informational posts/messages aligned with Social Cognitive Theory (SCT) to all participants. (d) Educational Modules. MS specific web-based interactive PA modules will be provided to patients.

Primary outcomes

  1. 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

  2. Utility of the ATOMIC program

    Time frame: Interview [30 minutes] at baseline

    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.

  3. Utility of the ATOMIC program

    Time frame: Interview [30 minutes] at 6 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.

  4. 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.

Other outcomes

  1. Effect of our physical activity (PA) intervention on MVPA level and the mediators of SCT

    Time frame: Entire study - Social Cognitive Mediators and Moderators of Physical Activity scales are completed at baseline, 6 weeks, 12 weeks, and 24 weeks.

    The effect of our PA intervention on MVPA level and the mediators and moderators of SCT (e.g. self efficacy) will be determined by calculating the change in time spent in MVPA and mediators and moderators of SCT at the completion of the intervention.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Queen's University
  • University of Alabama at Birmingham

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 3, 2017
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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