ConcussiontextingNCT03099733
Concussion Texting Study
A study testing text message in people with Concussion, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This will be a prospective study of the implementation of a real-time assessment and intervention of a text messaging tool in mild traumatic brain injury (mTBI) patients post-discharge from the emergency department. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Concussion
- What is being tested?
- text message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 9 Feb 2018
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 or greater and diagnosed with a concussion or closed head injury with intent to discharge from the ED
- Blunt trauma mechanism of injury
- GCS 14 or greater upon arrival to the ED
- The patient or caregiver owns a cell phone with text messaging capability
Who cannot join
- Penetrating trauma mechanism of injury
- The patient or caregiver does not own a cell phone with text messaging capability or is unwilling to receive text messages
- If the patient has a condition that makes him/her unable to communicate via text message
- Known unavailability (travel, planned surgery, etc.) during the follow-up period
- Planned admission to the hospital
- Abnormal CT, if obtained
Show all 11Show fewer
- Social issues that preclude follow-up
- Alcoholism
- Major psychiatric or personality disorder
- Incarceration or arrest
- Baseline cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
Official title: Development and Implementation of a Real-Time Assessment and Intervention for mTBI Patients Post-Discharge From the Emergency Department
This will be a prospective study of the implementation of a real-time assessment and intervention of a text messaging tool in mild traumatic brain injury (mTBI) patients post-discharge from the emergency department.
Read the detailed description
Traumatic brain injury (TBI) is an important cause of morbidity and mortality in children, resulting in an estimated 173,000 emergency department (ED) visits and 14,000 hospitalizations each year in the US. The estimated rate of TBI visits increased 57% from 2001-2009, and in 2010 there were more than 2.5 million TBI-related ED visits. Most patients are discharged from the ED and diagnosed with a closed head injury, minor head injury, concussion, or other unspecified head injury. After discharge, patients, family members, and other care partners may report certain mTBI symptoms that may lead to unnecessary utilization of healthcare services.
Novel, effective, and cost-effective solutions for mTBI symptom management post ED discharge are needed to improve the patient's understanding about their symptoms after discharge. Use of mobile technology to interact with mTBI patients may: 1) extend the reach of clinicians, 2) offer patients diagnosed with a mTBI a form of ongoing tailored clinical support, and 3) contribute to improved health outcomes and optimization of health care utilization. Previous research shows high compliance with text-message based interventions, measurable change in behavior, and prolonged adherence to clinical guidance. A recent randomized trial of mTBI patients showed high-compliance with text-message assessments following ED discharge, and a trend towards fewer and less severe post-mTBI symptoms in the intervention group. The investigators propose to develop and pilot a novel mobile phone text-messaging platform to perform real-time assessment and intervention of mTBI patients discharged from the ED. This intervention will empower patients to actively participate in the management of their condition. Use of this technology with the mTBI patient population is feasible and cost-effective. Over 90% of Americans own a cell phone or smartphone, and 80% send and receive text-messages.
The first objective of this research study is to develop and pilot the novel use of an existing technology, mobile phone text-messaging, to perform real-time assessment and feedback regarding symptoms of mTBI patients post-discharge from the ED. A second objective is to assess the effect of a brief, real-time, tailored intervention designed to impact patient and caregiver understanding of their mTBI related symptoms. The overarching goal of this proposal is to build on the work of Dr. Hirsch, et al. who found that: 1) mTBI patients report a poor understanding of concussion; 2) mTBI patients reported insufficient communication with clinicians regarding their symptoms following ED discharge (e.g., balance and sleep); and 3) mTBI patients reported poor care coordination, poor follow-up, and limited access to specialist physicians post-discharge.
Hypothesis: Based on prior work, implementation of a text-based tool for assessment and intervention of mTBI patients post-discharge from the CMC-Main \& LCH EDs will improve patient engagement related to mTBI. It is anticipated that 50% of potential study subjects will elect to receive text messages and that the differences in characteristics of enrolled participants versus non-participants will not be statistically significant. It is anticipated that > 75% of participants will respond/comply with the symptom assessment messages.
- Conditions
- Concussion
- Being tested
- text message
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text messageOther
Participants will receive text message assessment and tailored intervention messages daily over the 14-day/two-week study period.
| Study group | Role | What they receive |
|---|---|---|
| concussion | Experimental | patients who present to ED with concussion Receives: Other: text message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessment
The intervention will be determined to be feasible if the majority of subjects respond to the text messages and complete follow-up, and if the majority of subjects that are approached agree to participate. The demographic and baseline characteristics of participants and non-participants will be assessed for significant differences that may have influenced the feasibility assessment.
Measured: Study duration (one year, anticipated)
Secondary outcomes (2)
Identify obstacles associated with the text messaging instrument
Qualitative interview with participants by phone - participants will be asked about their thought and feelings related to the study assessment tool, relationships with the study physicians, text messaging impact on care and recommended changes.
Measured: 14 days
Healthcare utilization
To gauge the safety and effectiveness of the intervention, we will determine if there are patient level factors that increase the rate of follow-up and decrease direct cost of care.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start6 Feb 2017
- Primary completion9 Feb 2018
- Study completion9 Feb 2018
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.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Scarboro, MD, Principal investigator, Carolinas Medical Center/Atrium Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099733
- Sponsor's protocol ID
- 07-16-04A
- Acronym
- texting
- Status last verified
- Mar 2019
- First submitted
- 6 Feb 2017
- Last updated
- 27 Apr 2022
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of a Real-Time Assessment and Intervention for mTBI Patients Post-Discharge From the Emergency Department
- ClinicalTrials.gov ID
- NCT03099733
- Acronym / sponsor ID
- texting / 07-16-04A
- Conditions
- Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 4 Apr 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.
This will be a prospective study of the implementation of a real-time assessment and intervention of a text messaging tool in mild traumatic brain injury (mTBI) patients post-discharge from the emergency department.
Detailed description
Traumatic brain injury (TBI) is an important cause of morbidity and mortality in children, resulting in an estimated 173,000 emergency department (ED) visits and 14,000 hospitalizations each year in the US. The estimated rate of TBI visits increased 57% from 2001-2009, and in 2010 there were more than 2.5 million TBI-related ED visits. Most patients are discharged from the ED and diagnosed with a closed head injury, minor head injury, concussion, or other unspecified head injury. After discharge, patients, family members, and other care partners may report certain mTBI symptoms that may lead to unnecessary utilization of healthcare services.
Novel, effective, and cost-effective solutions for mTBI symptom management post ED discharge are needed to improve the patient's understanding about their symptoms after discharge. Use of mobile technology to interact with mTBI patients may: 1) extend the reach of clinicians, 2) offer patients diagnosed with a mTBI a form of ongoing tailored clinical support, and 3) contribute to improved health outcomes and optimization of health care utilization. Previous research shows high compliance with text-message based interventions, measurable change in behavior, and prolonged adherence to clinical guidance. A recent randomized trial of mTBI patients showed high-compliance with text-message assessments following ED discharge, and a trend towards fewer and less severe post-mTBI symptoms in the intervention group. The investigators propose to develop and pilot a novel mobile phone text-messaging platform to perform real-time assessment and intervention of mTBI patients discharged from the ED. This intervention will empower patients to actively participate in the management of their condition. Use of this technology with the mTBI patient population is feasible and cost-effective. Over 90% of Americans own a cell phone or smartphone, and 80% send and receive text-messages.
The first objective of this research study is to develop and pilot the novel use of an existing technology, mobile phone text-messaging, to perform real-time assessment and feedback regarding symptoms of mTBI patients post-discharge from the ED. A second objective is to assess the effect of a brief, real-time, tailored intervention designed to impact patient and caregiver understanding of their mTBI related symptoms. The overarching goal of this proposal is to build on the work of Dr. Hirsch, et al. who found that: 1) mTBI patients report a poor understanding of concussion; 2) mTBI patients reported insufficient communication with clinicians regarding their symptoms following ED discharge (e.g., balance and sleep); and 3) mTBI patients reported poor care coordination, poor follow-up, and limited access to specialist physicians post-discharge.
Hypothesis: Based on prior work, implementation of a text-based tool for assessment and intervention of mTBI patients post-discharge from the CMC-Main \& LCH EDs will improve patient engagement related to mTBI. It is anticipated that 50% of potential study subjects will elect to receive text messages and that the differences in characteristics of enrolled participants versus non-participants will not be statistically significant. It is anticipated that > 75% of participants will respond/comply with the symptom assessment messages.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| concussion | Experimental | Other: text messagepatients who present to ED with concussion |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 12 or greater and diagnosed with a concussion or closed head injury with intent to discharge from the ED
- Blunt trauma mechanism of injury
- GCS 14 or greater upon arrival to the ED
- The patient or caregiver owns a cell phone with text messaging capability
Key exclusion criteria (11 listed)
- Penetrating trauma mechanism of injury
- The patient or caregiver does not own a cell phone with text messaging capability or is unwilling to receive text messages
- If the patient has a condition that makes him/her unable to communicate via text message
- Known unavailability (travel, planned surgery, etc.) during the follow-up period
- Planned admission to the hospital
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 |
|---|---|---|
| text messageParticipants will receive text message assessment and tailored intervention messages daily over the 14-day/two-week study period. | Other | concussion |
Primary outcome
Feasibility assessment
Time frame: Study duration (one year, anticipated)
The intervention will be determined to be feasible if the majority of subjects respond to the text messages and complete follow-up, and if the majority of subjects that are approached agree to participate. The demographic and baseline characteristics of participants and non-participants will be assessed for significant differences that may have influenced the feasibility assessment.
2 secondary outcomes
Identify obstacles associated with the text messaging instrument
Time frame: 14 days
Healthcare utilization
Time frame: 3 months
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 27 Apr 2022.
- 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.
Chad Scarboro, MD principal investigator
Carolinas Medical Center/Atrium Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing text message in people with Concussion, run by Wake Forest University Health Sciences 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 4 inclusion and 11 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 27 Apr 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?
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 assessment (time frame: Study duration (one year, anticipated)). 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 27 Apr 2022.