An interventional study of text message in Concussion, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Other
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.
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.
550 studies on the registry are indexed under Brain Concussion; 154 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 376 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
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Exclusion Criteria:
patients who present to ED with concussion
Other: text message
Participants will receive text message assessment and tailored intervention messages daily over the 14-day/two-week study period.
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.
Time frame: Study duration (one year, anticipated)
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.
Time frame: 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.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Feb 2018, 12 months.
Of 222 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's 12 months is below that.
Counting every sponsor, half of 236 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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