Recruiting

Epilepsy Surgery

Sponsor:

Anny Reyes

Code:

NCT07509190

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PEERS Program

Surveys

Focus group

Study Details

Brief summary:

The goal of this study is to identify the needs and barriers to accessing and undergoing epilepsy surgery for patients with epilepsy and then to pilot an educational program regarding the social determinants of health and how they can influence surgical rates and epilepsy outcomes.

For the first part, patients (age 18+) and providers will be asked to complete surveys and participate in focus groups to identify gaps and barriers that limit access to and use of epilepsy surgery.

For piloting the education program, patients (age 18+) at the Cleveland Clinic Epilepsy Monitoring Unit will be randomized to intervention or control. Those in the intervention group, in addition to their usual care, will also receive educational materials on social determinants of health and their influence on surgical rates and epilepsy outcomes. Those in the control group will receive their usual care. Both groups will be asked to fill out surveys and questionnaires at the beginning of their stay, at the end of their stay, and if they elect to have surgery, 12 months after surgery.

Conditions

Epilepsy

Study ID

NCT07509190

Start date

Mar 18, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Part 1:
  • Epilepsy diagnosis
  • Completion of epilepsy surgical evaluation at Cleveland Clinic
  • Recommendation for resective/ablation surgery or implantation of neurostimulation device
  • At least 18 years old
  • Part 2a - Patient survey:
  • At least 18 years old
  • Epilepsy diagnosis
  • Evaluated for epilepsy surgery
  • English proficiency enough to complete survey
  • Part 2a - Provider survey:
  • Healthcare professional in the US who is involved in the clinical care or treatment of individuals with epilepsy
  • Part 2b - Cleveland Clinic patient focus groups:
  • Epilepsy diagnosis
  • Previously completed epilepsy workup at Cleveland Clinic
  • At least 18 years old
  • Has Basic Interpersonal Fluency Skills in English (based on phone interview)
  • Has no evidence of dementia or intellectual disability that would interfere with participation in the focus group
  • Part 2b - Cleveland Clinic provider focus groups:
  • Clinicians that are members of Cleveland Clinic Epilepsy Center and provide care to patients with epilepsy
  • Part 2b - Community patient focus groups:
  • Epilepsy diagnosis
  • Previously completed epilepsy workup
  • At least 18 years old
  • Has Basic Interpersonal Fluency Skills in English (based on phone interview)
  • Part 2b - Community provider focus groups:
  • Clinician that provides care to patients with epilepsy outside of Cleveland Clinic
  • Part 3:
  • At least 18 years old
  • Fluent in English
  • Being evaluated for epilepsy surgery at the Cleveland Clinic Epilepsy Monitoring Unit

Exclusion Criteria:

  • Part 1:
  • Previous epilepsy surgery or implantation of neurostimulation device
  • Part 2a - Patient survey:
  • Unable to fluently read English
  • Has evidence of dementia or intellectual disability that would interfere with patient's understanding of surveys
  • Part 2a - Provider survey:
  • Unable to fluently read English
  • Part 2b - Cleveland Clinic patient focus groups:
  • Is not fluent in English
  • Has evidence of dementia or intellectual disability that would interfere with patient's understanding of or ability to participate in the focus group
  • Has had prior epilepsy surgery
  • Part 2b - Cleveland Clinic provider focus groups:
  • Clinicians involved in the development of the study design
  • Part 2b - Community patient focus groups:
  • Is not fluent in English
  • Has evidence of dementia or intellectual disability that would interfere with patient's understanding of or ability to participate in the focus group
  • Has had prior epilepsy surgery
  • Part 3:
  • Is not fluent in English
  • Evidence of dementia or intellectual disability that would interfere with patient's understanding of intervention

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Part 2a: Patient Survey

Patients will receive online surveys to collect data to assess barriers to accessing epilepsy surgery

other: Part 2a: Provider Survey

Epilepsy providers will receive online surveys to collect data to assess barriers patients experience in accessing epilepsy surgery

other: Part 2b: Cleveland Clinic Patient Focus Group

Cleveland Clinic patients with epilepsy will fill out questionnaires and participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

other: Part 2b: Cleveland Clinic Provider Focus Group

Cleveland Clinic epilepsy providers will fill out questionnaires and participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

other: Part 2b: Community Patient Focus Group

Non-Cleveland Clinic patients with epilepsy will fill out questionnaires and participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

other: Part 2b: Community Provider Focus Group

Non-Cleveland Clinic epilepsy providers will fill out questionnaires and participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

experimental: Part 3: Intervention

Patients will view an educational video on social determinants of health and how these social determinants impact medical care while they are in the Cleveland Clinic Epilepsy Monitoring Unit in addition to their normal care.

no intervention: Part 3: Control

Patients will have care as usual while they are in the Cleveland Clinic Epilepsy Monitoring Unit

Interventions

PEERS Program

This is a video-based intervention complemented by additional education materials, focusing on educating people with epilepsy on the impact of social determinants of health on epilepsy surgery and outcomes

Surveys

Participants will receive surveys to assess barriers to accessing epilepsy care

Focus group

Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery

Primary outcome measure

  • Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery [ Time Frame: At study enrollment ]
  • Part 2b: Further identify barriers associated with lack of access and utilization of epilepsy surgery [ Time Frame: At study enrollment ]
  • Part 3: Determine acceptability of PEERS Program [ Time Frame: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit ]
  • Part 3: Determine satisfaction of PEERS Program [ Time Frame: Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit ]
  • Part 3: Determine effectiveness of PEERS Program [ Time Frame: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit ]

Central Contacts and Locations

Central contacts

Anny Reyes, PhD

216-390-4266REYESA14@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Anny Reyes, PhD

216-390-4266REYESA14@ccf.org

More Information

Sponsor

Anny Reyes

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anny Reyes on 2026-04-03.