Trials Sponsors Conditions Drugs Pricing

Conditions

Epilepsy, Post-Traumatic

Keywords

epilepsyneurological carecollaborative careanxietydepression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Subject Adherence to Intervention
Week 12
Change in Epilepsy specific QOLIE-31 score
Baseline through Month 6
Change in Beck Depression Inventory-II (BDI-II) score
From baseline through Month 6
Change in Beck Anxiety Index (BAI) score
From baseline through Month 6

Other Outcomes (22)

Feasibility of Intervention Measure (FIM)-Subject Perspective
Baseline and Month 3
FIM-Neurologist Perspective
Baseline and Month 3
Acceptability of Intervention Measure (AIM)-Subject Perspective
Baseline and Month 3
+19 more other outcomes

Study Arms (2)

Collaborative Care

EXPERIMENTAL

Participants in this arm will receive 24 weeks of neurology based collaborative care.

Behavioral: Neurology Based Collaborative Care

Standard of Care (SOC)

ACTIVE COMPARATOR

Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.

Behavioral: SOC Neurological care

Interventions

Neurology Based Collaborative CareBehavioral

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.

Collaborative Care

SOC Neurological careBehavioral

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures

Sponsors & Collaborators

Wake Forest University Health Sciences
Otherlead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Related Publications (1)

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.
PMID: 39535875DERIVED

MeSH Terms

Conditions

Epilepsy, Post-TraumaticEpilepsyAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesMental DisordersBehavioral SymptomsBehavior

Study Officials

Heidi M. Munger Clary, MD, MPH
Atrium Health Wake Forest Baptist
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

April 30, 2023

Actual (reported)

Collaborative Care in Posttraumatic Epilepsy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (22)

Study Arms (2)

Collaborative Care

Standard of Care (SOC)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (22)

Study Arms (2)

Collaborative Care

Standard of Care (SOC)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations