Epilepsy
Conditions
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.
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
BEHAVIORALUPLIFT
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.
BEHAVIORALPACES
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.
BEHAVIORALEnhanced Usual Care
Participants receive referrals to local epilepsy support groups.
Sponsors
NYU Langone Health
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5 | 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 | Post-Intervention Month 3 Follow-up (Approximately Month 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). |
| Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score | Baseline | 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 | Post-Intervention Month 6 Follow-up (Approximately Month 8) | 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 | 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 | Post-Intervention Month 3 Follow-up (Approximately Month 5) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in PHQ-9 Score | Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5) | 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. |
| Change from Baseline in QOLIE-31 | Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5) | 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. |
| Change from Baseline in Seizure Frequency | Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5) | — |
| Healthcare Utilization | Baseline | A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report. |
Countries
United States
Contacts
CONTACTTanya Spruill, PhD
PRINCIPAL_INVESTIGATORTanya Spruill, PhD
NYU Langone Health
Outcome results
None listed