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| ID | Type | Description | Link |
|---|---|---|---|
| 40010222 | Other Identifier | Department of Defense | |
| CDMRP-EP210036 | Other Identifier | CDMRP |
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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.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collaborative Care | Experimental | Participants in this arm will receive 24 weeks of neurology based collaborative care. |
|
| Standard of Care (SOC) | Active Comparator | Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurology Based Collaborative Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline through Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Change in Epilepsy specific QOLIE-31 score |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention Measure (FIM)-Subject Perspective | Questionnaire to help determine feasibility of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility. | Baseline and Month 3 |
| FIM-Neurologist Perspective |
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:
Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥8 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) >13
Receiving clinical neurological care at one of the study sites
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidi M. Munger Clary, MD, MPH | Contact | 336-716-7110 | hmungerc@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heidi M. Munger Clary, MD, MPH | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39535875 | Derived | Munger Clary HM, Snively BM, Cagle C, Kennerly R, Kimball JN, Alexander HB, Brenes GA, Moore JB, Hurley RA. Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2024 Nov 13;13:e59329. doi: 10.2196/59329. |
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| ID | Term |
|---|---|
| D004834 | Epilepsy, Post-Traumatic |
| D004827 | Epilepsy |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| SOC Neurological care | Behavioral | 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. |
|
Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life.
| Baseline through Month 6 |
| 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. | From baseline through Month 6 |
| Change in Beck Anxiety Index (BAI) score | Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms. | From baseline through Month 6 |
Questionnaire to help determine feasibility of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater feasibility. |
| Baseline and Month 3 |
| Acceptability of Intervention Measure (AIM)-Subject Perspective | Questionnaire to help determine acceptability of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability. | Baseline and Month 3 |
| AIM-Neurologist Perspective | Questionnaire to help determine acceptability of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater acceptability. | Baseline and Month 3 |
| Intervention Appropriateness Measure (IAM)-Subject Perspective | Questionnaire to help determine appropriateness of collaborative care from participants' perspectives. Score ranges from 5 to 20, with higher s indicating greater appropriateness. | Baseline and Month 3 |
| IAM-Neurologist Perspective | Questionnaire to help determine appropriateness of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating greater appropriateness. | Baseline and Month 3 |
| Proportion of participants who attend at least 50% of Scheduled Calls | Pertains only to participants randomized to collaborative care intervention | Week 12 and Week 24 |
| Individual Participant Collaborative Care Call Attendance Percentage | Week 12 and Week 24 |
| Seizure Frequency | Number of seizures experienced by participants | Baseline, Month 3, and Month 6 |
| Change in BDI-II Score | Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms. | From Baseline through Month 3 |
| Change in BAI Score | Anxiety symptom questionnaire- score ranges from 0-61, with higher score indicating more severe anxiety symptoms. | From Baseline through Month 3 |
| Change in Epilepsy specific QOLIE-31 Score | Score ranges from 0-100 with higher scores indicating better epilepsy-specific quality of life. | From Baseline through Month 3 |
| Emotional Subscale-Change in QOLIE-31 Score | 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. | Baseline through Month 3 |
| Change in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) | 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. | From Baseline through Month 6 |
| Change in Mini International Psychiatric Interview (MINI) | 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. | From Baseline through Month 6 |
| Change in Generic Quality of Life-SF-36 | 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. | From Baseline through Month 6 |
| Change in Liverpool Seizure Severity Scale (LSSS) | Seizure severity questionnaire- score ranges from 0 to 100, with higher score indicating increased seizure severity. | From Baseline through Month 6 |
| Prescription Adherence | Collected via review of pharmacy refills--number expected divided by number taken. | Month 6 |
| Change in Liverpool Adverse Effect Profile (LAEP) | Adverse effect questionnaire-score ranges from 19 to 76, with higher score indicating greater burden of adverse effects. | From Baseline through Month 6 |
| Change in Generalized Anxiety Disorders- 7(GAD-7) Score | Questionnaire measuring anxiety symptoms-score ranges from 0 to 21, with higher score indicating increased anxiety symptoms. | From Baseline through month 3, From Baseline through month 6 |
| Change in Patient Health Questionnaire-9 (PHQ-9) Score | Score ranges from 0 to 27, with higher score indicating increased depression symptoms. | From Baseline through month 3, From Baseline through month 6 |
| Emergency Department (ED)/Hospitalization Visits | Number of hospitalizations or visits to ED. | From baseline through Month 6 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |