NCT01668342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

July 10, 2012

Last Update Submit

May 26, 2015

Conditions

Head Injury, Minor

Outcome Measures

Primary Outcomes (1)

  • Rivermead Post Concussive Questionnaire

    14 days

Secondary Outcomes (1)

  • Rivermead Post Concussive Questionnaire

    3 months

Study Arms (2)

SMS assessments & feedback

EXPERIMENTAL

Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity.

Behavioral: SMS assessments & feedback

Control

NO INTERVENTION

Standard of care

Interventions

SMS assessments & feedbackBEHAVIORAL

Daily symptom assessments tied to tailored feedback

SMS assessments & feedback

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Critically ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center-Mercy Hospital

Pittsburgh, Pennsylvania, 15218, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Brian Suffoletto, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

August 20, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)