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

NCT ID: NCT01668342

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-09-30

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.

Conditions

Head Injury, Minor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SMS assessments & feedback

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

Group Type: EXPERIMENTAL

SMS assessments & feedback

Intervention Type: BEHAVIORAL

Daily symptom assessments tied to tailored feedback

Control

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SMS assessments & feedback

Daily symptom assessments tied to tailored feedback

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Critically ill

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Suffoletto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center-Mercy Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO12030542

Identifier Type: -

Identifier Source: org_study_id