Back to resultsCollaborative Care in Posttraumatic Epilepsy
Primary Purpose
Epilepsy, Post-Traumatic
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurology Based Collaborative Care
SOC Neurological care
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Post-Traumatic focused on measuring epilepsy, neurological care, collaborative care, anxiety, depression
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures
Diagnosis of post-traumatic epilepsy, defined by the following:
- Epilepsy diagnosis based on neurology clinician impression of diagnosis or electroencephalogram (EEG) findings (EEG findings: presence of interictal epileptiform discharges on EEG or ictal EEG recording of seizure definitively documenting epilepsy diagnosis)
- History of at least mild traumatic brain injury based on the MIRECC (Mental Illness Research, Education, and Clinical Center) TBI (Traumatic Brain Injury) screening instrument or verified TBI history based on MIRECC research database
- TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form)
- Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥10 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) >15
- Receiving clinical neurological care at one of the study sites
Exclusion Criteria:
- Active ongoing treatment by a psychiatrist
- Active suicidal ideation
- History of past suicide attempt
- Unstable drug or alcohol abuse
- Unstable or progressive comorbid medical condition
- Current participation in another treatment or intervention study
- Cognitive limitations precluding completion of anxiety and depression self-report instruments on paper, electronically, or by interview.
Sites / Locations
- Atrium Health Wake Forest Baptist
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Collaborative Care
Standard of Care (SOC)
Arm Description
Participants in this arm will receive 24 weeks of neurology based collaborative care.
Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
Outcomes
Primary Outcome Measures
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life
Secondary Outcome Measures
Subject Adherence to Intervention
Proportion of intervention arm participants who attend 50% or more of the care management calls in the first 12 weeks of the intervention.
Change in Epilepsy specific QOLIE-31 score
Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life.
Change in Beck Depression Inventory-II (BDI-II) score
Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.
Change in Beck Anxiety Index (BAI) score
Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms.
Full Information
NCT ID
NCT05353452
First Posted
April 25, 2022
Last Updated
June 30, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05353452
Brief Title
Collaborative Care in Posttraumatic Epilepsy
Official Title
Collaborative Care for Anxiety and Depression in Posttraumatic Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
The study will compare collaborative care versus usual care among N=60 adults with post-traumatic epilepsy and anxiety and/or depression symptoms in Veterans Administration (N=20) and civilian university (N=40) settings at the Salisbury VA and Atrium Health Wake Forest Baptist Health (AHWFB) Neurology. This single-blind study will evaluate effectiveness and implementation of a remotely-delivered, 24-week team-delivered collaborative care intervention, with features adapted from VA Primary Care Mental Health Integration and Whole Health, as well as an existing Family Medicine Collaborative Care Program at AHWFB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Post-Traumatic
Keywords
epilepsy, neurological care, collaborative care, anxiety, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collaborative Care
Arm Type
Experimental
Arm Description
Participants in this arm will receive 24 weeks of neurology based collaborative care.
Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
Intervention Type
Behavioral
Intervention Name(s)
Neurology Based Collaborative Care
Intervention Description
Twenty-four week, evidence-based remote collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager, psychiatrist, and psychologist/social worker who interact with the patient participant and the patient's neurologist.
Intervention Type
Behavioral
Intervention Name(s)
SOC Neurological care
Intervention Description
Usual neurology care means ongoing, epilepsy provider-recommended clinic visits, prescriptions, testing and referrals from their epilepsy provider. Mental health referrals or prescribing of antidepressants may potentially occur in this group; these types of interventions will be tracked at outcome assessments.
Primary Outcome Measure Information:
Title
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)
Description
This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life
Time Frame
Baseline through Month 6
Secondary Outcome Measure Information:
Title
Subject Adherence to Intervention
Description
Proportion of intervention arm participants who attend 50% or more of the care management calls in the first 12 weeks of the intervention.
Time Frame
Week 12
Title
Change in Epilepsy specific QOLIE-31 score
Description
Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life.
Time Frame
Baseline through Month 6
Title
Change in Beck Depression Inventory-II (BDI-II) score
Description
Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.
Time Frame
From baseline through Month 6
Title
Change in Beck Anxiety Index (BAI) score
Description
Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms.
Time Frame
From baseline through Month 6
Other Pre-specified Outcome Measures:
Title
Feasibility of Intervention Measure (FIM)-Subject Perspective
Description
Questionnaire to help determine feasibility of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility.
Time Frame
Baseline and Month 3
Title
FIM-Neurologist Perspective
Description
Questionnaire to help determine feasibility of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility.
Time Frame
Baseline and Month 3
Title
Acceptability of Intervention Measure (AIM)-Subject Perspective
Description
Questionnaire to help determine acceptability of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability.
Time Frame
Baseline and Month 3
Title
AIM-Neurologist Perspective
Description
Questionnaire to help determine acceptability of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability.
Time Frame
Baseline and Month 3
Title
Intervention Appropriateness Measure (IAM)-Subject Perspective
Description
Questionnaire to help determine appropriateness of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher s indicating greater appropriateness.
Time Frame
Baseline and Month 3
Title
IAM-Neurologist Perspective
Description
Questionnaire to help determine appropriateness of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater appropriateness.
Time Frame
Baseline and Month 3
Title
Proportion of participants who attend at least 50% of Scheduled Calls
Description
Pertains only to participants randomized to collaborative care intervention
Time Frame
Week 12 and Week 24
Title
Individual Participant Collaborative Care Call Attendance Percentage
Time Frame
Week 12 and Week 24
Title
Seizure Frequency
Description
Number of seizures experienced by participants
Time Frame
Baseline, Month 3, and Month 6
Title
Change in BDI-II Score
Description
Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.
Time Frame
From Baseline through Month 3
Title
Change in BAI Score
Description
Anxiety symptom questionnaire- score ranges from 0-61, with higher score indicating more severe anxiety symptoms.
Time Frame
From Baseline through Month 3
Title
Change in Epilepsy specific QOLIE-31 Score
Description
Score ranges from 0-100 with higher scores indicating better epilepsy-specific quality of life.
Time Frame
From Baseline through Month 3
Title
Emotional Subscale-Change in QOLIE-31 Score
Description
This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life.
Time Frame
Baseline through Month 3
Title
Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E)
Description
Depression symptom questionnaire specifically for those with epilepsy-score ranges from 6 to 24, with a score >15 indicating presence of a likely major depressive episode.
Time Frame
From Baseline through Month 6
Title
Change in Mini International Psychiatric Interview (MINI)
Description
Validated diagnostic interview for Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) psychiatric diagnoses. The instrument indicates whether a current diagnosis of a DSM-V mood or anxiety disorder is present. This outcome will assess for change in presence of a current anxiety or depressive disorder at 6-months compared to baseline.
Time Frame
From Baseline through Month 6
Title
Change in Generic Quality of Life-SF-36
Description
This instrument is composed of 8 subscales, each calculated separately on a scale of 0-100, with higher score indicating better generic health-related quality of life for that subscale. This exploratory outcome pertains to the following subscales: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning.
Time Frame
From Baseline through Month 6
Title
Change in Liverpool Seizure Severity Scale (LSSS)
Description
Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity.
Time Frame
From Baseline through Month 6
Title
Prescription Adherence
Description
Collected via review of pharmacy refills--number expected divided by number taken.
Time Frame
Month 6
Title
Change in Liverpool Adverse Effect Profile (LAEP)
Description
Adverse effect questionnaire-score ranges from 19 to 76, with higher score indicating greater burden of adverse effects.
Time Frame
From Baseline through Month 6
Title
Change in Generalized Anxiety Disorders- 7(GAD-7) Score
Description
Questionnaire measuring anxiety symptoms-score ranges from 0 to 21, with higher score indicating increased anxiety symptoms.
Time Frame
From Baseline through month 3, From Baseline through month 6
Title
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Description
Score ranges from 0 to 27, with higher score indicating increased depression symptoms.
Time Frame
From Baseline through month 3, From Baseline through month 6
Title
Emergency Department (ED)/Hospitalization Visits
Description
Number of hospitalizations or visits to ED.
Time Frame
From baseline through Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures
Diagnosis of post-traumatic epilepsy, defined by the following:
Epilepsy diagnosis based on neurology clinician impression of diagnosis or electroencephalogram (EEG) findings (EEG findings: presence of interictal epileptiform discharges on EEG or ictal EEG recording of seizure definitively documenting epilepsy diagnosis)
History of at least mild traumatic brain injury based on the MIRECC (Mental Illness Research, Education, and Clinical Center) TBI (Traumatic Brain Injury) screening instrument or verified TBI history based on MIRECC research database
TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form)
Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥10 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) >15
Receiving clinical neurological care at one of the study sites
Exclusion Criteria:
Active ongoing treatment by a psychiatrist
Active suicidal ideation
History of past suicide attempt
Unstable drug or alcohol abuse
Unstable or progressive comorbid medical condition
Current participation in another treatment or intervention study
Cognitive limitations precluding completion of anxiety and depression self-report instruments on paper, electronically, or by interview.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi M. Munger Clary, MD, MPH
Phone
336-716-7110
Email
hmungerc@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi M. Munger Clary, MD, MPH
Organizational Affiliation
Atrium Health Wake Forest Baptist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi M. Munger Clary, MD, MPH
Phone
336-716-7110
Email
hmungerc@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Heidi M. Munger Clary, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Collaborative Care in Posttraumatic Epilepsy
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