NYU Epilepsy Self-Management Study
Economic Evaluation of Managing Epilepsy Well (MEW) Network Epilepsy Self-Management Programs
2 other identifiers
interventional
108
1 country
2
Brief Summary
The investigators will conduct two-arm randomized controlled trials (RCTs) comparing effects of UPLIFT vs. enhanced usual care and PACES vs. enhanced usual care, respectively, on quality of life, depressive symptoms and seizures over 12 months in NYU patients with epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2025
CompletedStudy Start
First participant enrolled
July 18, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 29, 2027
July 28, 2025
July 1, 2025
2.2 years
July 17, 2025
July 24, 2025
Conditions
Outcome Measures
Primary Outcomes (12)
Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5
RCT 1 participants only. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Baseline
Number of Participants with PHQ-9 Score <5
RCT 1 participants only. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Post-Intervention Month 3 Follow-up (Approximately Month 5)
Number of Participants with PHQ-9 Score <5
RCT 1 participants only. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Post-Intervention Month 6 Follow-up (Approximately Month 8)
Number of Participants with PHQ-9 Score <5
RCT 1 participants only. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Post-Intervention Month 12 Follow-up (Approximately Month 14)
Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score
RCT 2 participants only. The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Baseline
Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score
RCT 2 participants only. The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Post-Intervention Month 3 Follow-up (Approximately Month 5)
Composite PHQ-9 and QOLIE-31 Score
RCT 2 participants only. The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Post-Intervention Month 6 Follow-up (Approximately Month 8)
Composite PHQ-9 and QOLIE-31 Score
RCT 2 participants only. The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Post-Intervention Month 12 Follow-up (Approximately Month 14)
5-level EQ-5D version (EQ-5D-5L) Score
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
Baseline
EQ-5D-5L Score
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
Post-Intervention Month 3 Follow-up (Approximately Month 5)
EQ-5D-5L Score
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
Post-Intervention Month 6 Follow-up (Approximately Month 8)
EQ-5D-5L Score
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
Post-Intervention Month 12 Follow-up (Approximately Month 14)
Secondary Outcomes (13)
Change from Baseline in PHQ-9 Score
Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in PHQ-9 Score
Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in PHQ-9 Score
Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)
Change from Baseline in QOLIE-31
Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in QOLIE-31
Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
- +8 more secondary outcomes
Study Arms (4)
RCT 1: UPLIFT
EXPERIMENTALParticipants in RCT 1 assigned to the UPLIFT arm.
RCT 1: Enhanced Usual Care
ACTIVE COMPARATORParticipants in RCT 1 assigned to the enhanced usual care arm.
RCT 2: PACES
EXPERIMENTALParticipants in RCT 2 assigned to the PACES arm.
RCT 2: Enhanced Usual Care
ACTIVE COMPARATORParticipants in RCT 2 assigned to the enhanced usual care arm.
Interventions
UPLIFT is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. UPLIFT is focused on self-management of depressive symptoms. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment.
PACES is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. PACES focuses on general epilepsy self-management. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment.
Participants receive referrals to local epilepsy support groups.
Eligibility Criteria
You may qualify if:
- Adults (≥18 years)
- English-speaking (UPLIFT and PACES) or Spanish-speaking (UPLIFT only).
- Diagnosed with epilepsy for at least one year
- Able to understand the informed consent and provide consent
- Elevated depressive symptoms - Patient Health Questionnaire-9 (PHQ-9) score ≥10; applies to UPLIFT only
You may not qualify if:
- Severe depressive symptoms (score of ≥20 on PHQ-9)
- Active suicidal ideation (score of ≥1 on PHQ-9 item #9 or otherwise reported during screening)
- Active psychotic disorder (psychiatric diagnosis and/or antipsychotic medications in the electronic health records (EHR)
- Significant cognitive impairment (indicated in the EHR or evident during screening)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Centers for Disease Control and Preventioncollaborator
Study Sites (2)
NYU Langone Health - NYU Langone Hospital-Brooklyn
Brooklyn, New York, 11220, United States
NYU Langone Health - NYU Comprehensive Epilepsy Center
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanya Spruill, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2025
First Posted
July 28, 2025
Study Start
July 18, 2025
Primary Completion (Estimated)
September 29, 2027
Study Completion (Estimated)
September 29, 2027
Last Updated
July 28, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposes to use the data will be granted access upon reasonable request. Requests should be directed to Tanya.Spruill@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Tanya.Spruill@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.