ConcussionOnTRACKNCT05065099
Online Treatment Recovery Assistance for Concussion in Kids
A study testing Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK) in people with Concussion and MTBI - Mild Traumatic Brain Injury, run by Children's National Research Institute at 1 site in United States.
Trial summary
The investigators propose to develop a software platform, OnTRACK (Online Treatment Recovery Assistance for Concussion in Kids), for children and adolescents recovering from concussion or mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Concussion, MTBI - Mild Traumatic Brain Injury
- What is being tested?
- Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2022to 31 Dec 2022
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthcare providers (HCP) (n =28):
- Primary care practitioners and their clinical assistants (e.g., nurse, PA) (n = 22)
- Practitioners from the SCORE Concussion and Neurology clinics at Children's National (n = 6)
- Patient/ Parent (n = 134 pairs):
- Children aged 8-17 years old
- Children who sustained a concussion within 7 days prior to visiting their primary care practice, and within 30 days of visiting the specialty clinics
Show all 14Show fewer
- Children and parents must be fluent English speakers
- Children and parents must be agreeable to the study conditions, and able to provide informed assent/ parent consent
- School Staff member (n = 134):
- Members of faculty at the school the patient attends
- Pre-selected by child/parent
- Fluent in English language
- Agreeable to study conditions, and able to sign consent forms
- Children/parents who's school will not participate will still be eligible to participate
Who cannot join
- Children with significant developmental, cognitive, language, psychiatric, other neurological disease, or significant motor or visual impairments, specifically if they do not allow adequate comprehension of the study goals and materials
- Patients with pre-injury histories of developmental disorders (e.g., ADHD, LD), mild-moderate anxiety or mood disorders, and other medical diseases that are under control (e.g., asthma, diabetes, headaches, seizures) are all eligible to participate in the study
- Children who have suffered a severe prior brain injury or have had a prior concussion within the past 3 months
- Caregivers who have significant cognitive limitations
- Individuals with English-language comprehension limitations
- School staff who are unable to meet with the student on a regular basis to review the app information and/or complete the questionnaires during the workday
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Safe Concussion Outcome Recovery & Education (SCORE) Clinic at Children's National Hospital
Rockville, Maryland, 20850
Dean R Allen, ma, 301-765-5458, drallen@childrensnational.org
About this study
Official title: OnTRACK: Mobile Application for Pediatric Post-Concussion Patient Management - Phase 2
The investigators propose to develop a software platform, OnTRACK (Online Treatment Recovery Assistance for Concussion in Kids), for children and adolescents recovering from concussion or mild traumatic brain injury (mTBI). The platform includes a mobile application (app) for the patients and their care team (parents, teachers, coaches, etc.), a database server, and a decision support dashboard for healthcare providers. The OnTRACK app prompts the patient to report post-concussion symptoms across recovery in two distinct but equally important ways: a weekly cross-recovery graded symptom ratings to track overall recovery progress, and short-term daily dynamic exertional symptom responses to guide tolerable daily activity. Teachers and parents and other authorized members of the patient care team also report patient progress when prompted. Beyond symptom reporting, the app provides access to education in the form of short multimedia clips that cover various topics related to concussion recovery based on the PACE (Progressive Activities of Controlled Exertion) model. Using several large existing datasets on recovery trajectories, the serial symptom reports indicate (a) level of symptom severity, change over time, and whether recovery is following a typical or atypical pattern. The healthcare provider is regularly updated regarding recovery progress and, if an atypical pattern is reported, he/she receives an alert to assess further and consider referral for additional treatment. To guide daily recovery, OnTRACK uses empirically-derived algorithms to determine when the level of symptom exacerbation reaches a certain threshold, delivering an alert to the healthcare provider who can give feedback to the child to manage daily activities and reduce disruptive symptoms. The primary goal of the OnTRACK system is to afford the healthcare provider, patient, and family greater confidence with data-driven decisions upon which to follow evidence-based treatment guidelines and to improve communication between family and provider.
Read the detailed description
The investigators will study the usability of a smartphone app (Online Treatment Recovery Assistant for Concussion in Kids, OnTRACK), its effect on provider management confidence, and communication plus a preliminary analysis of the benefits on patient recovery outcomes. The study will recruit 126 children, parent, school staff triads (n=378) along with their healthcare provider (HCP) including 22 primary care from the CN Pediatric Health Network and 8 specialists from the CN Safe Concussion Outcome, Recovery \& Education (SCORE) clinics and Neurology clinics. The participants will track and monitor the child's symptoms and respond to HCP guidance over the course of recovery (up to 12 weeks), employing evidence-based algorithms related to recovery progress. The investigators hypothesize that the HCP will experience: (1) positive satisfaction in using the app, (2) increased confidence in their management guidance, and (3) increased communication with patients, families and school staff when using the OnTRACK app as compared to a control group who receives standard treatment without the OnTRACK app. The investigators further hypothesize that in using the OnTRACK app as compared with control group, patients, parents and school personnel will report: (1) positive satisfaction in using the app, (2) increased confidence in their symptom management, and (3) increased communication with the HCP. Additionally, the investigators hypothesize that the OnTRACK educational videos will be rated as useful and improve the understanding of the patient, parent and school regarding concussion and its management. Finally, the investigators hypothesize that patients will develop a better understanding of the dynamics of their exertional symptoms as related to school and home activities by tracking their occurrence and learning productive strategies to manage them.
- Conditions
- Concussion, MTBI - Mild Traumatic Brain Injury
- Being tested
- Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)
- Keywords
- Concussion, mTBI, Mild Traumatic Brain Injury, Mobile Application, Symptom Monitoring, Pediatric, Children, Healthcare Provider Support
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)Device
Also called OnTRACK
Patients and families will be provided the smartphone app on their personal mobile phone (Android, iPhone) or provided with a phone if they do not own one. The patients will view educational videos on concussion management, input their daily exertional status and weekly symptom status upon receiving pre-programmed notification prompts on their phone. Healthcare Providers will monitor symptom recovery via an HCP dashboard and make management recommendations using evidence-based algorithms regarding symptom recovery status. School personnel will monitor progress via a dashboard and provide targeted supports, they may also view educational videos on concussion management. Opportunities for communication between the HCP, parent/patient and school will be provided by the app.
| Study group | Role | What they receive |
|---|---|---|
| OnTRACK Intervention | Experimental | In the intervention condition, HCPs will be trained in the usage of the OnTRACK system.
They will be oriented to the educational videos, the symptom tracking, and the interpretation of the data that is provided by the patients and families, and the associated management strategies based on that data. Additionally, patients and parents will be trained to use the OnTRACK smartphone app on their phone from diagnosis to recovery (or 12 weeks if not recovered), including daily exertional monitoring symptom ratings and use of the educational videos. School personnel will be introduced to the OnTRACK app and the data summary features in the school dashboard and the associated supports that can be provided to the student based on that data. Receives: Device: Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK) |
| Treatment as Usual | No intervention | In the control condition, the HCP provides "usual/standard care" to the patients and parents as is the practice within the specific clinic. The OnTRACK app and the educational modules are not provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The usability of the OnTRACK symptom monitoring system
Patients, Parents, HCPs, and School Personnel in the intervention group will complete an OnTRACK App/Portal User Satisfaction Survey
Measured: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.
The OnTRACK symptom monitoring system's effect on the HCP confidence in clinical decision-making, patient/ parent/ school confidence in carrying out management guidance
Parents, HCPs, and School Personnel will each complete the Concussion Management Self-Efficacy Scale. Scores range from 0-120 on the Parent scale, 0-190 on the HCP scale, and 0-170 on the Teacher scale. Patients will complete the Progressive Activities of Cognitive Exertion scale- Self (score range: 0-170), with higher scores representing higher levels of confidence/self-efficacy for each of the four scales.
Measured: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.
Communication with Patients, Parents, HCPs and School Staff
A measure of satisfaction with the communication process between the family and HCP as well as between the HCP and school will be administered. Patient families, HCPs, and School Staff will complete the Communication Effectiveness Scale. Score ranges for the Patients/Parents scale is 0-90, HCP is 0-70, and School Staff is 0-80.
Measured: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.
Secondary outcomes (5)
Examine patient symptom recovery outcomes (self-reported)
Symptom Recovery Status: Self-reported via Post-Concussion Symptom Inventory (PCSI) PCSI-Self score range: 0-126 (Adolescent), 0-34 (Child)
Measured: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Examine patient symptom recovery outcomes (parent reported)
Symptom Recovery Status: Parent-reported via Post-Concussion Symptom Inventory (PCSI) PCSI-Parent score range: 0-120
Measured: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Examine patient symptom recovery outcomes relating to school (self-reported)
Symptom Recovery Status: Self-reported via Concussion Learning Assessment and School Survey (CLASS-3) The CLASS-3 collects information regarding the patient's academic performance, across several areas: General Concern (0-3), Total Problems (0-14, total sum = 0-42), Total Stresses (0-6, total sum = 0-18), New/Worsening Trouble (total sum = 0-16), and Total Supports Needed/Received (0-unlimited), with higher scores reflecting greater academic difficulty/more support required.
Measured: Participants will complete the survey when they are no longer symptomatic and are deemed recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Examine patient symptom recovery outcomes relating to school (school-reported)
Symptom Recovery Status: School-reported via Concussion Learning Assessment and School Survey (CLASS-3) The CLASS-3 collects information regarding the patient's academic performance, across several areas: General Concern (0-3), Total Problems (0-14, total sum = 0-42), Total Stresses (0-6, total sum = 0-18), New/Worsening Trouble (total sum = 0-16), and Total Supports Needed/Received (0-unlimited), with higher scores reflecting greater academic difficulty/more support required.
Measured: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Change in knowledge associated with the educational videos
Patients, Parents, HCPs, and School Personnel will complete an Educational video user survey
Measured: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study startFeb 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will employ a quasi-experimental mixed design occurring in two sequential phases, assigning the first half of the sample to the control (standard care) group, and the second half to the OnTRACK intervention group. The between-subjects variable will be assignment to intervention or control condition and the within-subjects variable being time (beginning of recovery, end of recovery) to address the specific aims of the study.
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Creare, Inc.
- Responsible party
- Principal investigator, Gerard A. Gioia, Children's National Research Institute
- Investigators
- Gerard Gioia, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065099
- Sponsor's protocol ID
- Pro00014094
- Acronym
- OnTRACK
- Status last verified
- Jan 2022
- First submitted
- 26 Jul 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OnTRACK: Mobile Application for Pediatric Post-Concussion Patient Management - Phase 2
- ClinicalTrials.gov ID
- NCT05065099
- Acronym / sponsor ID
- OnTRACK / Pro00014094
- Conditions
- Concussion, MTBI - Mild Traumatic Brain Injury
- Keywords
- Concussion, mTBI, Mild Traumatic Brain Injury, Mobile Application, Symptom Monitoring, Pediatric, Children, Healthcare Provider Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Creare, Inc.
- Study start
- Feb 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Oct 2021 (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.
The investigators propose to develop a software platform, OnTRACK (Online Treatment Recovery Assistance for Concussion in Kids), for children and adolescents recovering from concussion or mild traumatic brain injury (mTBI). The platform includes a mobile application (app) for the patients and their care team (parents, teachers, coaches, etc.), a database server, and a decision support dashboard for healthcare providers. The OnTRACK app prompts the patient to report post-concussion symptoms across recovery in two distinct but equally important ways: a weekly cross-recovery graded symptom ratings to track overall recovery progress, and short-term daily dynamic exertional symptom responses to guide tolerable daily activity. Teachers and parents and other authorized members of the patient care team also report patient progress when prompted. Beyond symptom reporting, the app provides access to education in the form of short multimedia clips that cover various topics related to concussion recovery based on the PACE (Progressive Activities of Controlled Exertion) model. Using several large existing datasets on recovery trajectories, the serial symptom reports indicate (a) level of symptom severity, change over time, and whether recovery is following a typical or atypical pattern. The healthcare provider is regularly updated regarding recovery progress and, if an atypical pattern is reported, he/she receives an alert to assess further and consider referral for additional treatment. To guide daily recovery, OnTRACK uses empirically-derived algorithms to determine when the level of symptom exacerbation reaches a certain threshold, delivering an alert to the healthcare provider who can give feedback to the child to manage daily activities and reduce disruptive symptoms. The primary goal of the OnTRACK system is to afford the healthcare provider, patient, and family greater confidence with data-driven decisions upon which to follow evidence-based treatment guidelines and to improve communication between family and provider.
Detailed description
The investigators will study the usability of a smartphone app (Online Treatment Recovery Assistant for Concussion in Kids, OnTRACK), its effect on provider management confidence, and communication plus a preliminary analysis of the benefits on patient recovery outcomes. The study will recruit 126 children, parent, school staff triads (n=378) along with their healthcare provider (HCP) including 22 primary care from the CN Pediatric Health Network and 8 specialists from the CN Safe Concussion Outcome, Recovery \& Education (SCORE) clinics and Neurology clinics. The participants will track and monitor the child's symptoms and respond to HCP guidance over the course of recovery (up to 12 weeks), employing evidence-based algorithms related to recovery progress. The investigators hypothesize that the HCP will experience: (1) positive satisfaction in using the app, (2) increased confidence in their management guidance, and (3) increased communication with patients, families and school staff when using the OnTRACK app as compared to a control group who receives standard treatment without the OnTRACK app. The investigators further hypothesize that in using the OnTRACK app as compared with control group, patients, parents and school personnel will report: (1) positive satisfaction in using the app, (2) increased confidence in their symptom management, and (3) increased communication with the HCP. Additionally, the investigators hypothesize that the OnTRACK educational videos will be rated as useful and improve the understanding of the patient, parent and school regarding concussion and its management. Finally, the investigators hypothesize that patients will develop a better understanding of the dynamics of their exertional symptoms as related to school and home activities by tracking their occurrence and learning productive strategies to manage them.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will employ a quasi-experimental mixed design occurring in two sequential phases, assigning the first half of the sample to the control (standard care) group, and the second half to the OnTRACK intervention group. The between-subjects variable will be assignment to intervention or control condition and the within-subjects variable being time (beginning of recovery, end of recovery) to address the specific aims of the study.
| Arm | Type | Receives |
|---|---|---|
| OnTRACK Intervention | Experimental | Device: Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)In the intervention condition, HCPs will be trained in the usage of the OnTRACK system. They will be oriented to the educational videos, the symptom tracking, and the interpretation of the data that is provided by the patients and families, and the associated management strategies based on that data. Additionally, patients and parents will be trained to use the OnTRACK smartphone app on their phone from diagnosis to recovery (or 12 weeks if not recovered), including daily exertional monitoring symptom ratings and use of the educational videos. School personnel will be introduced to the OnTRACK app and the data summary features in the school dashboard and the associated supports that can be provided to the student based on that data. |
| Treatment as Usual | No intervention | –In the control condition, the HCP provides "usual/standard care" to the patients and parents as is the practice within the specific clinic. The OnTRACK app and the educational modules are not provided. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Primary care practitioners and their clinical assistants (e.g., nurse, PA) (n = 22)
- Practitioners from the SCORE Concussion and Neurology clinics at Children's National (n = 6)
- Children aged 8-17 years old
- Children who sustained a concussion within 7 days prior to visiting their primary care practice, and within 30 days of visiting the specialty clinics
- Children and parents must be fluent English speakers
Key exclusion criteria (6 listed)
- Children with significant developmental, cognitive, language, psychiatric, other neurological disease, or significant motor or visual impairments, specifically if they do not allow adequate comprehension of the study goals and materials
- Children who have suffered a severe prior brain injury or have had a prior concussion within the past 3 months
- Caregivers who have significant cognitive limitations
- Individuals with English-language comprehension limitations
- School staff who are unable to meet with the student on a regular basis to review the app information and/or complete the questionnaires during the workday
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 |
|---|---|---|
| Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)Also: OnTRACKPatients and families will be provided the smartphone app on their personal mobile phone (Android, iPhone) or provided with a phone if they do not own one. The patients will view educational videos on concussion management, input their daily exertional status and weekly symptom status upon receiving pre-programmed notification prompts on their phone. Healthcare Providers will monitor symptom recovery via an HCP dashboard and make management recommendations using evidence-based algorithms regarding symptom recovery status. School personnel will monitor progress via a dashboard and provide targeted supports, they may also view educational videos on concussion management. Opportunities for communication between the HCP, parent/patient and school will be provided by the app. | Device | OnTRACK Intervention |
Primary outcome
The usability of the OnTRACK symptom monitoring system
Time frame: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.
Patients, Parents, HCPs, and School Personnel in the intervention group will complete an OnTRACK App/Portal User Satisfaction Survey
The OnTRACK symptom monitoring system's effect on the HCP confidence in clinical decision-making, patient/ parent/ school confidence in carrying out management guidance
Time frame: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.
Parents, HCPs, and School Personnel will each complete the Concussion Management Self-Efficacy Scale. Scores range from 0-120 on the Parent scale, 0-190 on the HCP scale, and 0-170 on the Teacher scale. Patients will complete the Progressive Activities of Cognitive Exertion scale- Self (score range: 0-170), with higher scores representing higher levels of confidence/self-efficacy for each of the four scales.
Communication with Patients, Parents, HCPs and School Staff
Time frame: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.
A measure of satisfaction with the communication process between the family and HCP as well as between the HCP and school will be administered. Patient families, HCPs, and School Staff will complete the Communication Effectiveness Scale. Score ranges for the Patients/Parents scale is 0-90, HCP is 0-70, and School Staff is 0-80.
5 secondary outcomes
Examine patient symptom recovery outcomes (self-reported)
Time frame: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Examine patient symptom recovery outcomes (parent reported)
Time frame: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Examine patient symptom recovery outcomes relating to school (self-reported)
Time frame: Participants will complete the survey when they are no longer symptomatic and are deemed recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Examine patient symptom recovery outcomes relating to school (school-reported)
Time frame: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Change in knowledge associated with the educational videos
Time frame: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. The questionnaire will take five minutes to complete.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
Gerard Gioia, PhD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK) in people with Concussion and MTBI - Mild Traumatic Brain Injury, run by Children's National Research Institute at 1 site in United States.
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 14 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dean R Allen, MA ((301)765-5458, drallen@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The usability of the OnTRACK symptom monitoring system (time frame: Participants will complete the survey when they are no longer symptomatic and are deemed clinically recovered, or at 12 weeks after enrollment if they are not recovered. Questionnaires will take five minutes to complete.). The study lists 3 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 11 Jan 2022.