Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients

Head Injury, Minor Clinical Trial

Official title:

Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668342
• Other study ID #: PRO12030542
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2012
• Last updated: May 26, 2015
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of minor traumatic brain injury

• English speaking

• Owns a cell phone with SMS

Exclusion Criteria:

• Critically ill

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury, Minor

Intervention

Behavioral:
• SMS assessments & feedback
Daily symptom assessments tied to tailored feedback

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center-Mercy Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rivermead Post Concussive Questionnaire		14 days	Yes
Secondary	Rivermead Post Concussive Questionnaire		3 months	Yes