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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
108
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.
NYU Langone Health - NYU Langone Hospital-Brooklyn
Brooklyn, New York, United States
RECRUITINGNYU Langone Health - NYU Comprehensive Epilepsy Center
New York, New York, United States
RECRUITINGNumber 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
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Participants receive referrals to local epilepsy support groups.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-Intervention Month 12 Follow-up (Approximately Month 14)
Change from Baseline in PHQ-9 Score
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.
Time frame: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in PHQ-9 Score
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.
Time frame: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in PHQ-9 Score
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.
Time frame: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)
Change from Baseline in QOLIE-31
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.
Time frame: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in QOLIE-31
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.
Time frame: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in QOLIE-31
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.
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
A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report.
Time frame: Baseline
Healthcare Utilization
A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report.
Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)
Healthcare Utilization
A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report.
Time frame: Post-Intervention Month 6 Follow-up (Approximately Month 8)
Healthcare Utilization
A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report.
Time frame: Post-Intervention Month 12 Follow-up (Approximately Month 14)