NYU Epilepsy Self-Management Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое Enhanced Usual Care
  Participants receive referrals to local epilepsy support groups.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

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

Идентификаторы

NCT: NCT07087821 · 25-00151 · U48DP006844

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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