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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01668342
First received: July 10, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Head Injury, Minor
Behavioral: SMS assessments & feedback
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Rivermead Post Concussive Questionnaire [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rivermead Post Concussive Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668342

Contacts
Contact: Brian Suffoletto, MD MS 412-647-1518

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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01668342     History of Changes
Other Study ID Numbers: PRO12030542
Study First Received: July 10, 2012
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014