EpilepsyNCT07509190
Bridging the Gap: Educating Patients on Social Determinants of Health to Improve Epilepsy Surgery Access and Outcomes
A study testing PEERS Program, Surveys and Focus group in people with Epilepsy, run by Anny Reyes at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- PEERS Program, Surveys and Focus group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Anny Reyes, PhD, 216-390-4266, REYESA14@ccf.org
About this study
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
- Being tested
- PEERS Program, Surveys, Focus group
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEERS ProgramBehavioural
Also called Patient Empowerment through Education on Equity Research and Social Determinants 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
SurveysOther
Participants will receive surveys to assess barriers to accessing epilepsy care
Focus groupOther
Participants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery
| Study group | Role | What they receive |
|---|---|---|
| Part 2a: Patient Survey | Other | Patients will receive online surveys to collect data to assess barriers to accessing epilepsy surgery Receives: Other: Surveys |
| Part 2a: Provider Survey | Other | Epilepsy providers will receive online surveys to collect data to assess barriers patients experience in accessing epilepsy surgery Receives: Other: Surveys |
| Part 2b: Cleveland Clinic Patient Focus Group | Other | 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 Receives: Other: Focus group |
| Part 2b: Cleveland Clinic Provider Focus Group | Other | 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 Receives: Other: Focus group |
| Part 2b: Community Patient Focus Group | Other | 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 Receives: Other: Focus group |
| Part 2b: Community Provider Focus Group | Other | 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 Receives: Other: Focus group |
| Part 3: Intervention | Experimental | 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. Receives: Behavioral: PEERS Program |
| Part 3: Control | No intervention | Patients will have care as usual while they are in the Cleveland Clinic Epilepsy Monitoring Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery
People with epilepsy and providers will be asked to complete a roughly 20 minutes online survey (providers receive a different form of the survey than what patients receive)
Measured: At study enrollment
Part 2b: Further identify barriers associated with lack of access and utilization of epilepsy surgery
People with epilepsy and epilepsy providers (both from within Cleveland Clinic and from the outside community) will be asked to fill out surveys and participate in focus groups with semi-structured interviews
Measured: At study enrollment
Part 3: Determine acceptability of PEERS Program
Acceptability will be measured by baseline and post-intervention assessment completion, with success defined as greater than 80% of participants completing both assessments.
Measured: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 3: Determine satisfaction of PEERS Program
Measured by the Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)
Measured: Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 3: Determine effectiveness of PEERS Program
Measured by the Trust in Physician Scale (Min-Max 11-55; higher number is higher level of trust)
Measured: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Secondary outcomes (8)
Part 2b: Reporting of social needs
The Accountable Health Communities Health-Related Social Needs Screening Tool will be used to assess participants' reporting of social needs. This is a screening tool so there are no high/low values or total score
Measured: At study enrollment
Part 3: Reporting of social needs
The Accountable Health Communities Health-Related Social Needs (HRSN) Screening Tool will be used to assess participants' reporting of social needs. This is a screening tool so there are not high/low values or total scores
Measured: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: To assess knowledge of epilepsy surgery
Measured by responses to the Epilepsy Surgery Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)
Measured: At study enrollment
Part 3: To assess knowledge of epilepsy surgery
Measured by responses to the Epilepsy Surgery Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)
Measured: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: To assess knowledge of social determinants of health
Measured by responses to the Social Determinants of Health Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)
Measured: At study enrollment
Part 3: To assess knowledge of social determinants of health
Measured by responses to the Social Determinants of Health Knowledge Questionnaire (min/max 0-10; higher scores indicate higher knowledge)
Measured: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: Determine participants' positivity towards living with a chronic condition
Measured by the Living with Chronic Illness Scale (min/max 0-104; higher values reflects more positive attitude towards living with a chronic condition)
Measured: At study enrollment
Part 3: Determine participants' positivity towards living with a chronic condition
Measured by the Living with Chronic Illness Scale (min/max 0-104; higher values reflects more positive attitude towards living with a chronic condition)
Measured: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start18 Mar 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anny Reyes
- Sponsor type
- University, hospital or other
- Collaborators
- American Epilepsy Society
- Responsible party
- Sponsor-investigator, Anny Reyes, The Cleveland Clinic
- Investigators
- Anny Reyes, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509190
- Sponsor's protocol ID
- IRB 25-693
- Other IDs
- AES2510AR
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Gap: Educating Patients on Social Determinants of Health to Improve Epilepsy Surgery Access and Outcomes
- ClinicalTrials.gov ID
- NCT07509190
- Acronym / sponsor ID
- IRB 25-693
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Anny ReyesUniversity, hospital or other
- Collaborators
- American Epilepsy Society
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 2a: Patient Survey | Other | Other: SurveysPatients will receive online surveys to collect data to assess barriers to accessing epilepsy surgery |
| Part 2a: Provider Survey | Other | Other: SurveysEpilepsy providers will receive online surveys to collect data to assess barriers patients experience in accessing epilepsy surgery |
| Part 2b: Cleveland Clinic Patient Focus Group | Other | Other: Focus groupCleveland 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 |
| Part 2b: Cleveland Clinic Provider Focus Group | Other | Other: Focus groupCleveland 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 |
| Part 2b: Community Patient Focus Group | Other | Other: Focus groupNon-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 |
| Part 2b: Community Provider Focus Group | Other | Other: Focus groupNon-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 |
| Part 3: Intervention | Experimental | Behavioral: PEERS ProgramPatients 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. |
| Part 3: Control | No intervention | –Patients will have care as usual while they are in the Cleveland Clinic Epilepsy Monitoring Unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEERS ProgramAlso: Patient Empowerment through Education on Equity Research and Social Determinants ProgramThis 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 | Behavioural | Part 3: Intervention |
| SurveysParticipants will receive surveys to assess barriers to accessing epilepsy care | Other | Part 2a: Patient Survey, Part 2a: Provider Survey |
| Focus groupParticipants will participate in focus groups to further identify barriers associated with lack of access and utilization of epilepsy surgery | Other | Part 2b: Cleveland Clinic Patient Focus Group, Part 2b: Cleveland Clinic Provider Focus Group, Part 2b: Community Patient Focus Group, Part 2b: Community Provider Focus Group |
Primary outcome
Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery
Time frame: At study enrollment
People with epilepsy and providers will be asked to complete a roughly 20 minutes online survey (providers receive a different form of the survey than what patients receive)
Part 2b: Further identify barriers associated with lack of access and utilization of epilepsy surgery
Time frame: At study enrollment
People with epilepsy and epilepsy providers (both from within Cleveland Clinic and from the outside community) will be asked to fill out surveys and participate in focus groups with semi-structured interviews
Part 3: Determine acceptability of PEERS Program
Time frame: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Acceptability will be measured by baseline and post-intervention assessment completion, with success defined as greater than 80% of participants completing both assessments.
Part 3: Determine satisfaction of PEERS Program
Time frame: Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Measured by the Client Satisfaction Questionnaire (Min-Max 8-32, higher number is greater satisfaction)
Part 3: Determine effectiveness of PEERS Program
Time frame: Baseline, and Prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Measured by the Trust in Physician Scale (Min-Max 11-55; higher number is higher level of trust)
8 secondary outcomes
Part 2b: Reporting of social needs
Time frame: At study enrollment
Part 3: Reporting of social needs
Time frame: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: To assess knowledge of epilepsy surgery
Time frame: At study enrollment
Part 3: To assess knowledge of epilepsy surgery
Time frame: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: To assess knowledge of social determinants of health
Time frame: At study enrollment
Part 3: To assess knowledge of social determinants of health
Time frame: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Part 2b: Determine participants' positivity towards living with a chronic condition
Time frame: At study enrollment
Part 3: Determine participants' positivity towards living with a chronic condition
Time frame: At baseline, and prior to discharge from the Cleveland Clinic Epilepsy Monitoring Unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anny Reyes, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEERS Program, Surveys and Focus group in people with Epilepsy, run by Anny Reyes at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anny Reyes, PhD (216-390-4266, REYESA14@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 2a: Identify primary barriers to accessing and undergoing epilepsy surgery (time frame: At study enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.