Back to resultsMobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
Primary Purpose
Head Injury, Minor
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SMS assessments & feedback
Sponsored by
About this trial
This is an interventional supportive care trial for Head Injury, Minor
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of minor traumatic brain injury
- English speaking
- Owns a cell phone with SMS
Exclusion Criteria:
- Critically ill
Sites / Locations
- University of Pittsburgh Medical Center-Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SMS assessments & feedback
Control
Arm Description
Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity.
Standard of care
Outcomes
Primary Outcome Measures
Rivermead Post Concussive Questionnaire
Secondary Outcome Measures
Rivermead Post Concussive Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01668342
Brief Title
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
Official Title
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury, Minor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMS assessments & feedback
Arm Type
Experimental
Arm Description
Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
SMS assessments & feedback
Intervention Description
Daily symptom assessments tied to tailored feedback
Primary Outcome Measure Information:
Title
Rivermead Post Concussive Questionnaire
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Rivermead Post Concussive Questionnaire
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of minor traumatic brain injury
English speaking
Owns a cell phone with SMS
Exclusion Criteria:
Critically ill
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Suffoletto, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center-Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15218
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
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