Concussion Texting Study

NCT03099733 | Completed

• 1 other identifier: 07-16-04A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concussion

Outcome Measures

Primary Outcomes (1)

• 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.

  Study duration (one year, anticipated)

Secondary Outcomes (2)

• Identify obstacles associated with the text messaging instrument

  14 days

• Healthcare utilization

  3 months

Study Arms (1)

concussion

EXPERIMENTAL

patients who present to ED with concussion

Other: text message

Interventions

text message OTHER

Participants will receive text message assessment and tailored intervention messages daily over the 14-day/two-week study period.

concussion

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Social issues that preclude follow-up
• Alcoholism
• Major psychiatric or personality disorder
• Incarceration or arrest
• Baseline cognitive impairment

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Chad Scarboro, MD

  Carolinas Medical Center/Atrium Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: April 4, 2017
• Study Start: February 6, 2017
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: April 27, 2022

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)