ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study
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|ClinicalTrials.gov Identifier: NCT03137602|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Multiple Sclerosis||Device: ATOMIC mobile app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03137602
|Contact: E. Ann Yeh, M.D.||416-813-7654 ext firstname.lastname@example.org|
|Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G1X8|
|Contact: Stephanie Grover, MSc 416-813-7654 ext 203796 email@example.com|
|Contact: Samantha Stephens, PhD 416-813-7654 ext 328936 firstname.lastname@example.org|