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

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ClinicalTrials.gov Identifier: NCT01668342
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh

July 10, 2012
August 20, 2012
May 27, 2015
June 2012
July 2013   (Final data collection date for primary outcome measure)
Rivermead Post Concussive Questionnaire [ Time Frame: 14 days ]
Same as current
Complete list of historical versions of study NCT01668342 on ClinicalTrials.gov Archive Site
Rivermead Post Concussive Questionnaire [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Head Injury, Minor
Behavioral: SMS assessments & feedback
Daily symptom assessments tied to tailored feedback
  • Experimental: SMS assessments & feedback
    Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity.
    Intervention: Behavioral: SMS assessments & feedback
  • No Intervention: Control
    Standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
200
September 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of minor traumatic brain injury
  • English speaking
  • Owns a cell phone with SMS

Exclusion Criteria:

  • Critically ill
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01668342
PRO12030542
Yes
Not Provided
Not Provided
University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Brian Suffoletto, MD University of Pittsburgh
University of Pittsburgh
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP