Economic Evaluation of Managing Epilepsy Well (MEW) Network Epilepsy Self-Management Programs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
RCT 1: Enhanced Usual Care
Participants in RCT 1 assigned to the enhanced usual care arm.
干预措施: Enhanced Usual Care (Behavioral)
RCT 1: UPLIFT
Participants in RCT 1 assigned to the UPLIFT arm.
干预措施: UPLIFT (Behavioral)
RCT 2: PACES
Participants in RCT 2 assigned to the PACES arm.
干预措施: PACES (Behavioral)
RCT 2: Enhanced Usual Care
Participants in RCT 2 assigned to the enhanced usual care arm.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5
时间窗: Baseline
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).
Number of Participants with PHQ-9 Score <5
时间窗: Post-Intervention Month 12 Follow-up (Approximately Month 14)
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).
Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score
时间窗: Post-Intervention Month 3 Follow-up (Approximately Month 5)
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.
Composite PHQ-9 and QOLIE-31 Score
时间窗: Post-Intervention Month 12 Follow-up (Approximately Month 14)
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.
5-level EQ-5D version (EQ-5D-5L) Score
时间窗: Baseline
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.
EQ-5D-5L Score
时间窗: Post-Intervention Month 12 Follow-up (Approximately Month 14)
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.
次要结局
- 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 12 Follow-up (Approximately Month 14))
- Change from Baseline in Seizure Frequency(Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14))
- Healthcare Utilization(Post-Intervention Month 12 Follow-up (Approximately Month 14))