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.

Study Overview

• Status: Completed
• Conditions: Pediatric Multiple Sclerosis
• Intervention / Treatment: Device: ATOMIC mobile app

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • Hospital for sick children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the ATOMIC program	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	Entire study - up to 24 weeks
Utility of the ATOMIC program	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.	Interview [30 minutes] at baseline
Utility of the ATOMIC program	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.	Interview [30 minutes] at 6 weeks
Utility of the ATOMIC program	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.	Interview [30 minutes] at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of our physical activity (PA) intervention on MVPA level and the mediators of SCT	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.	Entire study - Social Cognitive Mediators and Moderators of Physical Activity scales are completed at baseline, 6 weeks, 12 weeks, and 24 weeks.

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: University of Alabama at Birmingham; Queen's University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (ACTUAL): May 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 1000055499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No