Pediatric Multiple SclerosisNCT03137602
ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study
A study testing ATOMIC mobile app in people with Pediatric Multiple Sclerosis, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Pediatric Multiple Sclerosis
- What is being tested?
- ATOMIC mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- MS diagnosis following standard definitions (IPMSSG);
- EDSS <4.0;
- Ability to speak English.
Who cannot join
- Known cardiac disease, including cyanotic congenital heart disease;
- inability to understand instructions and tolerate proposed testing or vigorous PA.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Pediatric Multiple Sclerosis
- Being tested
- ATOMIC mobile app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATOMIC mobile appDevice
(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.
| Study group | Role | What they receive |
|---|---|---|
| ATOMIC mobile app | Other | 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. Receives: Device: ATOMIC mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Interview [30 minutes] at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start7 Mar 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Queen's University
- Responsible party
- Principal investigator, E. Ann Yeh, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137602
- Sponsor's protocol ID
- 1000055499
- Status last verified
- Oct 2019
- First submitted
- 3 Jan 2017
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03137602
- Acronym / sponsor ID
- 1000055499
- Conditions
- Pediatric Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Queen's University
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATOMIC mobile app | Other | Device: ATOMIC mobile appThe 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. |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- MS diagnosis following standard definitions (IPMSSG);
- EDSS <4.0;
- Ability to speak English.
Key exclusion criteria (2 listed)
- Known cardiac disease, including cyanotic congenital heart disease;
- inability to understand instructions and tolerate proposed testing or vigorous PA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ATOMIC mobile app |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATOMIC mobile app in people with Pediatric Multiple Sclerosis, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the ATOMIC program (time frame: Entire study - up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.