Collaborative Care in Posttraumatic Epilepsy
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT05353452
- Status
- Recruiting
Conditions
- Epilepsy, Post-Traumatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Neurology Based Collaborative Care — BEHAVIORALTwenty-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.
- SOC Neurological care — BEHAVIORALUsual 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.
Study Details
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.
Key Dates
- Start date
- Apr 30, 2023
- Status verified
- Jan 2026
- Primary completion
- May 19, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 56 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Collaborative CareParticipants in this arm will receive 24 weeks of neurology based collaborative care.
- Active Comparator: Standard of Care (SOC)Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
Primary Outcome Measure
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31) [ Time Frame: Baseline through Month 6 ]
Central Contacts
- Heidi M. Munger Clary, MD, MPH336-716-7110
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | Heidi M. Munger Clary, MD, MPH (PRINCIPAL_INVESTIGATOR) |
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