Trial Outcomes & Findings for Smart Phone Application for Postconcussion Symptom Reduction (NCT NCT02501642)

Last Updated: 2023-07-28

Results Overview

The Neurobehavioral Symptom Inventory is a 22-item questionnaire developed to evaluate post-concussive symptom severity following mild TBI (Cicerone and Kalmar 1995). Participants are asked to rate each symptom on a scale of 0-4 (None, Mild, Moderate, Severe, Very Severe) with three different categories of symptoms: Affective/psychological/stress, somatic/physical and cognitive (reflecting three factors). Scores can range from 0-88, with higher scores indicating more severe symptom endorsement.

Recruitment status

COMPLETED

Study phase

Target enrollment

479 participants

Primary outcome timeframe

3 months

Results posted on

2023-07-28

Participant Flow

Enrollment closed on 9.30.2018

Enrollment closed on 9.30.2018 N/A

Participant milestones

Participant milestones
Measure	Concussion Coach Group After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach "Explorer" version Concussion Coach: smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies	Treatment as Usual Treatment as usual: Treatment as usual
Overall Study STARTED	238	241
Overall Study COMPLETED	231	230
Overall Study NOT COMPLETED	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Concussion Coach Group After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach "Explorer" version Concussion Coach: smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies	Treatment as Usual Treatment as usual: Treatment as usual
Overall Study Lost to Follow-up	7	11

Baseline Characteristics

missing data for gender

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Concussion Coach Group n=238 Participants After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach "Explorer" version Concussion Coach: smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies	Treatment as Usual n=241 Participants Treatment as usual: Treatment as usual	Total n=479 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=238 Participants	0 Participants n=241 Participants	0 Participants n=479 Participants
Age, Categorical Between 18 and 65 years	238 Participants n=238 Participants	241 Participants n=241 Participants	479 Participants n=479 Participants
Age, Categorical >=65 years	0 Participants n=238 Participants	0 Participants n=241 Participants	0 Participants n=479 Participants
Age, Continuous	36 years STANDARD_DEVIATION 16 • n=238 Participants	35 years STANDARD_DEVIATION 15 • n=241 Participants	35.5 years STANDARD_DEVIATION 15.5 • n=479 Participants
Sex: Female, Male Female	21 Participants n=230 Participants • missing data for gender	21 Participants n=228 Participants • missing data for gender	42 Participants n=458 Participants • missing data for gender
Sex: Female, Male Male	209 Participants n=230 Participants • missing data for gender	207 Participants n=228 Participants • missing data for gender	416 Participants n=458 Participants • missing data for gender
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=238 Participants	1 Participants n=241 Participants	3 Participants n=479 Participants
Race (NIH/OMB) Asian	3 Participants n=238 Participants	1 Participants n=241 Participants	4 Participants n=479 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=238 Participants	13 Participants n=241 Participants	15 Participants n=479 Participants
Race (NIH/OMB) Black or African American	37 Participants n=238 Participants	41 Participants n=241 Participants	78 Participants n=479 Participants
Race (NIH/OMB) White	183 Participants n=238 Participants	171 Participants n=241 Participants	354 Participants n=479 Participants
Race (NIH/OMB) More than one race	1 Participants n=238 Participants	1 Participants n=241 Participants	2 Participants n=479 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=238 Participants	13 Participants n=241 Participants	23 Participants n=479 Participants
Region of Enrollment United States	238 Participants n=238 Participants	241 Participants n=241 Participants	479 Participants n=479 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Concussion Coach Group n=231 Participants After informed consent and randomization, participants will complete baseline study measures and will receive an iPod touch® with the Concussion Coach "Explorer" version Concussion Coach: smart phone app with educational material on postconcussion symptoms and behavioral self-monitoring/strategies	Treatment as Usual n=230 Participants Treatment as usual: Treatment as usual
Neurobehavioral Symptom Inventory	33 score on a scale Standard Deviation 16	33 score on a scale Standard Deviation 17

Adverse Events

Concussion Coach Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tracy Kretzmer, Ph.D.

James A. Haley VA

Phone: 813-972-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place