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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03137602
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : March 9, 2018
University of Alabama at Birmingham
Queen's University
Information provided by (Responsible Party):
E. Ann Yeh, 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.

Condition or disease Intervention/treatment Phase
Pediatric Multiple Sclerosis Device: ATOMIC mobile app Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Device: ATOMIC mobile app
(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 Outcome Measures :
  1. Feasibility [ Time Frame: Entire study ]
    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: Entire study - Interviews [30 minutes] at baseline, 6 weeks and 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 Outcome Measures:
  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 and 12 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03137602

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Contact: E. Ann Yeh, M.D. 416-813-7654 ext 207353

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Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Stephanie Grover, MSc    416-813-7654 ext 203796   
Contact: Samantha Stephens, PhD    416-813-7654 ext 328936   
Sponsors and Collaborators
The Hospital for Sick Children
University of Alabama at Birmingham
Queen's University

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Responsible Party: E. Ann Yeh, Associate Scientist, Research Institute, The Hospital for Sick Children Identifier: NCT03137602     History of Changes
Other Study ID Numbers: 1000055499
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases