- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03137602
ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study
October 15, 2019 updated by: E. Ann Yeh, The Hospital for Sick Children
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X8
- Hospital for sick children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
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.
|
(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
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
|
Entire study - up to 24 weeks
|
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.
|
Interview [30 minutes] at baseline
|
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.
|
Interview [30 minutes] at 6 weeks
|
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.
|
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
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.
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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