Neurology Based Collaborative Care for Impact Seizure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atrium Health Wake Forest Baptist, Winston-Salem, NC
Impact Seizure+1 More
Neurology Based Collaborative Care - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of this research is to evaluate a 6 month change in quality of life in subjects who receive collaborative care calls compared to those subjects who receive usual neurology care. This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic epilepsy.

Eligible Conditions

  • Impact Seizure

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, Month 3, and Month 6

Baseline and Month 3
AIM-Neurologist Perspective
Acceptability of Intervention Measure (AIM)-Subject Perspective
FIM-Neurologist Perspective
Feasibility of Intervention Measure (FIM)-Subject Perspective
IAM-Neurologist Perspective
Intervention Appropriateness Measure (IAM)-Subject Perspective
Baseline through Month 3
Emotional Subscale-Change in QOLIE-31 Score
Baseline through Month 6
Change in Epilepsy specific QOLIE-31 score
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
Month 6
Seizure Frequency
Month 3
Change in BAI Score
Change in BDI-II Score
Change in Epilepsy specific QOLIE-31 Score
Month 6
Change in Generic Quality of Life-SF-36
Change in Liverpool Adverse Effect Profile (LAEP)
Change in Liverpool Seizure Severity Scale (LSSS)
Change in Mini International Psychiatric Interview (MINI)
Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E)
Month 6
Change in Generalized Anxiety Disorders- 7(GAD-7) Score
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Month 6
Change in Beck Anxiety Index (BAI) score
Change in Beck Depression Inventory-II (BDI-II) score
Emergency Department (ED)/Hospitalization Visits
Month 6
Prescription Adherence
Week 12
Subject Adherence to Intervention
Week 24
Individual Participant Collaborative Care Call Attendance Percentage
Proportion of participants who attend at least 50% of Scheduled Calls

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care (SOC)
1 of 2
Collaborative Care
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Neurology Based Collaborative Care · No Placebo Group · N/A

Collaborative Care
Behavioral
Experimental Group · 1 Intervention: Neurology Based Collaborative Care · Intervention Types: Behavioral
Standard of Care (SOC)
Behavioral
ActiveComparator Group · 1 Intervention: SOC Neurological care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 3, and month 6
Closest Location: Atrium Health Wake Forest Baptist · Winston-Salem, NC
N/AFirst Recorded Clinical Trial
0 TrialsResearching Impact Seizure
0 CompletedClinical Trials

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,100 Previous Clinical Trials
1,128,965 Total Patients Enrolled
Heidi M. Munger Clary, MD, MPHPrincipal InvestigatorAtrium Health Wake Forest Baptist
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a traumatic brain injury (TBI) and you have not had epilepsy for at least one year.
You have generalized anxiety disorder or major depressive disorder

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.