<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01668342</url>
  </required_header>
  <id_info>
    <org_study_id>PRO12030542</org_study_id>
    <nct_id>NCT01668342</nct_id>
  </id_info>
  <brief_title>Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients</brief_title>
  <official_title>Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mild traumatic brain injury (MTBI) is frequently seen in the ED, post-concussive symptoms are&#xD;
      common post-injury, and few MTBI patients receive treatment or follow-up for these symptoms.&#xD;
      Cell phones are ubiquitous, text messaging (SMS) is a cheap and increasingly common form of&#xD;
      communication, potentially allowing for accurate assessment of symptom patterns after MTBI&#xD;
      and provision of basic education support . The investigators seek to assess the feasibility&#xD;
      of using SMS to collect symptoms related to MTBI in patients either discharged from the ED or&#xD;
      admitted to the inpatient trauma unit. The investigators also seek to explore how SMS-based&#xD;
      symptom reports correlate with phone-based follow-up reports at 14 days and whether&#xD;
      additional SMS-based educational feedback alters daily symptom patterns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators seek to assess the feasibility of using SMS to collect symptoms related to&#xD;
      MTBI in patients either discharged from the ED or admitted to the inpatient trauma unit. The&#xD;
      investigators also seek to explore how SMS-based symptom reports correlate with phone-based&#xD;
      follow-up reports at 14 days and whether additional SMS-based educational feedback alters&#xD;
      daily symptom patterns at 3-months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rivermead Post Concussive Questionnaire</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rivermead Post Concussive Questionnaire</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Head Injury, Minor</condition>
  <arm_group>
    <arm_group_label>SMS assessments &amp; feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS assessments &amp; feedback</intervention_name>
    <description>Daily symptom assessments tied to tailored feedback</description>
    <arm_group_label>SMS assessments &amp; feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of minor traumatic brain injury&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Owns a cell phone with SMS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critically ill&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Suffoletto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center-Mercy Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01668342
org study id: PRO12030542
nct id: NCT01668342
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rivermead Post Concussive Questionnaire
time frame: 14 days
measure: Rivermead Post Concussive Questionnaire
time frame: 3 months
arm group label: SMS assessments & feedback
arm group type: Experimental
description: Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity.
arm group label: Control
arm group type: No Intervention
description: Standard of care
intervention type: Behavioral
intervention name: SMS assessments & feedback
description: Daily symptom assessments tied to tailored feedback
arm group label: SMS assessments & feedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Brian Suffoletto, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Sponsor
mesh term: Craniocerebral Trauma
mesh term: Wounds and Injuries