Head Injury, MinorPhase 1NCT01668342
Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
A Phase 1 study testing SMS assessments & feedback in people with Head Injury, Minor, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Head Injury, Minor
- What is being tested?
- SMS assessments & feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of minor traumatic brain injury
- English speaking
- Owns a cell phone with SMS
Who cannot join
- Critically ill
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center-Mercy Hospital
Pittsburgh, Pennsylvania, 15218
About this study
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.
Read the 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
- Being tested
- SMS assessments & feedback
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS assessments & feedbackBehavioural
Daily symptom assessments tied to tailored feedback
| Study group | Role | What they receive |
|---|---|---|
| SMS assessments & feedback | Experimental | Daily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity. Receives: Behavioral: SMS assessments & feedback |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivermead Post Concussive Questionnaire
Measured: 14 days
Secondary outcomes (1)
Rivermead Post Concussive Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injury, MinorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Suffoletto, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668342
- Sponsor's protocol ID
- PRO12030542
- Status last verified
- May 2015
- First submitted
- 10 Jul 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients
- ClinicalTrials.gov ID
- NCT01668342
- Acronym / sponsor ID
- PRO12030542
- Conditions
- Head Injury, Minor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS assessments & feedback | Experimental | Behavioral: SMS assessments & feedbackDaily symptom assessments of headaches, trouble ocncentrating and irritability/anxiety with self-care feedback based on response severity. |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of minor traumatic brain injury
- English speaking
- Owns a cell phone with SMS
Key exclusion criteria (1 listed)
- Critically ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS assessments & feedbackDaily symptom assessments tied to tailored feedback | Behavioural | SMS assessments & feedback |
Primary outcome
Rivermead Post Concussive Questionnaire
Time frame: 14 days
1 secondary outcome
Rivermead Post Concussive Questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Suffoletto, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SMS assessments & feedback in people with Head Injury, Minor, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rivermead Post Concussive Questionnaire (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015; AzTrials last refreshed its copy on 27 Oct 2026.