Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
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Purpose
Mild traumatic brain injury (MTBI) is frequently seen in the ED, post-concussive symptoms are common post-injury, and few MTBI patients receive treatment or follow-up for these symptoms. Cell phones are ubiquitous, text messaging (SMS) is a cheap and increasingly common form of communication, potentially allowing for accurate assessment of symptom patterns after MTBI and provision of basic education support . The investigators seek to assess the feasibility of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based symptom reports correlate with phone-based follow-up reports at 14 days and whether additional SMS-based educational feedback alters daily symptom patterns.
| Condition | Intervention | Phase |
|---|---|---|
|
Head Injury, Minor |
Behavioral: SMS assessments & feedback |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients |
- Rivermead Post Concussive Questionnaire [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Rivermead Post Concussive Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SMS assessments & feedback
Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity.
|
Behavioral: SMS assessments & feedback
Daily symptom assessments tied to tailored feedback
|
|
No Intervention: Control
Standard of care
|
Detailed Description:
The investigators seek to assess the feasibility of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based symptom reports correlate with phone-based follow-up reports at 14 days and whether additional SMS-based educational feedback alters daily symptom patterns at 3-months.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of minor traumatic brain injury
- English speaking
- Owns a cell phone with SMS
Exclusion Criteria:
- Critically ill
Contacts and Locations| Contact: Brian Suffoletto, MD MS | 412-647-1518 |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center-Mercy Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15218 | |
| Contact: Brian Suffoletto, MD MS | |
| Principal Investigator: | Brian Suffoletto, MD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01668342 History of Changes |
| Other Study ID Numbers: | PRO12030542 |
| Study First Received: | July 10, 2012 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Craniocerebral Trauma Trauma, Nervous System Nervous System Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013