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 — 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.
  • 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.

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 Care
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Heidi M. Munger Clary, MD, MPH
336-716-7110
Heidi M. Munger Clary, MD, MPH (PRINCIPAL_INVESTIGATOR)

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