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MHealth for Traumatic Brain Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Traumatic Brain Injury+5 MoreMHealth - Device
Eligibility
Any Age
All Sexes
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Study Summary

This trial will compare the outcomes of people with chronic health conditions who use a mobile health system to those who receive standard care.

Eligible Conditions
  • Traumatic Brain Injury
  • Spinal Cord Injury
  • Spina Bifida
  • Cerebral Palsy
  • Traumatic Brain Injury (TBI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

8 Primary · 3 Secondary · Reporting Duration: Through study completion, an average of 1 year.

Month 12
Psychosocial Outcomes- Change of Depressive Symptoms Over time as assessed by Depressive Symptoms questionnaire.
Psychosocial Outcomes-Change of Function Ratings Over Time as assessed by Function or Physical Independence questionnaire.
Psychosocial Outcomes-Change of Perceived Function and Satisfaction Over Time as assessed by Perceived Function and Satisfaction questionnaire.
Psychosocial Outcomes-Change of Quality of Life Over Time as assessed by Quality of Life questionnaire.
Psychosocial Outcomes-Change of Self Management Skills Over Time as assessed by Self Management Questionnaire
Month 12
Change of Participants' experience using the mHealth system over time as assessed by questionnaire
Year 1
Cost of care
Medical Outcomes-Improvements in Frequency of Health Care Utilization based on Medical Record Review and Questionnaire.
Medical Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review
Medical Outcomes-Improvements in Preventable Conditions based on Medical Record Review
Usage of the system as assessed by questionnaire and record review of the system usage (a built-in function in the system)

Trial Safety

Safety Progress

1 of 3

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1
Real LED Intervention
2
Phase 3; MYOBLOC
3
Licart™ (diclofenac epolamine) topical system

Trial Design

2 Treatment Groups

Control
1 of 2
MHealth Group
1 of 2

Active Control

Experimental Treatment

160 Total Participants · 2 Treatment Groups

Primary Treatment: MHealth · No Placebo Group · N/A

MHealth Group
Device
Experimental Group · 1 Intervention: MHealth · Intervention Types: Device
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year.

Who is running the clinical trial?

Department of Health and Human ServicesFED
201 Previous Clinical Trials
468,540 Total Patients Enrolled
University of PittsburghLead Sponsor
1,617 Previous Clinical Trials
16,299,548 Total Patients Enrolled
Brad E. Dicianno, M.D.Study DirectorUniversity of Pittsburgh
Bambang Parmanto, Ph.D.Study DirectorUniversity of Pittsburgh
Andi Saptono, Ph.D.Principal Investigator - University of Pittsburgh
University of Pittsburgh

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

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References

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