NYU Epilepsy Self-Management Study

Official title

Economic Evaluation of Managing Epilepsy Well (MEW) Network Epilepsy Self-Management Programs

Overview

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.

Detailed description

UPLIFT and PACES are two evidence-based epilepsy self-management programs whose adoption and impact are limited by the lack of sustainable funding models.

The investigators will conduct an economic evaluation of these programs using data from completed and new trials in both healthcare and community settings.

The investigators will conduct two parallel RCTs to compare effects of UPLIFT vs. enhanced usual care, and separately, PACES vs. enhanced usual care.

Outcome data including patient-reported outcomes and costs will be aligned across the two trials and community implementation and collected at baseline and 3-, 6-, and 12-month follow-up visits for use in the economic evaluations.

Interventions

• Behavioral UPLIFT
  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.
• Behavioral PACES
  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.
• Behavioral Enhanced Usual Care
  Participants receive referrals to local epilepsy support groups.

Primary outcome measures

• Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5 [Time frame: Baseline]
• Number of Participants with PHQ-9 Score <5 [Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)]
• Number of Participants with PHQ-9 Score <5 [Time frame: Post-Intervention Month 6 Follow-up (Approximately Month 8)]
• Number of Participants with PHQ-9 Score <5 [Time frame: Post-Intervention Month 12 Follow-up (Approximately Month 14)]
• Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score [Time frame: Baseline]
• Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score [Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)]
• Composite PHQ-9 and QOLIE-31 Score [Time frame: Post-Intervention Month 6 Follow-up (Approximately Month 8)]
• Composite PHQ-9 and QOLIE-31 Score [Time frame: Post-Intervention Month 12 Follow-up (Approximately Month 14)]
• 5-level EQ-5D version (EQ-5D-5L) Score [Time frame: Baseline]
• EQ-5D-5L Score [Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)]

Secondary outcome measures (12)

• Change from Baseline in PHQ-9 Score [Time frame: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)]
• Change from Baseline in PHQ-9 Score [Time frame: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)]
• Change from Baseline in PHQ-9 Score [Time frame: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)]
• Change from Baseline in QOLIE-31 [Time frame: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)]
• Change from Baseline in QOLIE-31 [Time frame: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)]
• Change from Baseline in QOLIE-31 [Time frame: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)]
• Change from Baseline in Seizure Frequency [Time frame: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)]
• Change from Baseline in Seizure Frequency [Time frame: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)]
• Change from Baseline in Seizure Frequency [Time frame: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)]
• Healthcare Utilization [Time frame: Baseline]
• Healthcare Utilization [Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)]
• Healthcare Utilization [Time frame: Post-Intervention Month 6 Follow-up (Approximately Month 8)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• NYU Langone Health - NYU Langone Hospital-Brooklyn — Brooklyn
• NYU Langone Health - NYU Comprehensive Epilepsy Center — New York

Identifiers

NCT: NCT07087821 · 25-00151 · U48DP006844

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗