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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):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Head Injury, Minor Behavioral: SMS assessments & feedback Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
Study Start Date : June 2012
Primary Completion Date : July 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Rivermead Post Concussive Questionnaire [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Rivermead Post Concussive Questionnaire [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Critically ill
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668342


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center-Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15218
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Brian Suffoletto, MD University of Pittsburgh
More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01668342     History of Changes
Other Study ID Numbers: PRO12030542
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases