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

Pediatric Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137602
• Other study ID #: 1000055499
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pediatric Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Queen's University, University of Alabama at Birmingham

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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
Primary	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
Primary	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
Primary	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