Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants Retained in the Study in the EMR Arm
研究概览
简要总结
The purpose of this research is to find out how people with epilepsy and possible symptoms of anxiety or depression are doing for 6 months after a regular epilepsy clinic visit. Participants in this study will complete questionnaires either by phone or via the patient portal.
详细描述
This is a study among N=30 individuals with epilepsy and high or borderline anxiety or depression symptoms receiving usual care at the Wake Forest Comprehensive Epilepsy Center. Participants are randomized to one of two outcome assessment methods [Electronic Medical Record (EMR)-based-interventional method vs. telephone-based-standard method] for collecting quality of life, anxiety and depression outcomes at 3 and 6 months, under usual care management.
The primary aim of the study is to assess feasibility of EMR-based outcome assessment by measuring 6-month retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome group assignment will not be blinded to the primary investigator or primary study coordinator, as it will be necessary for these individuals to know outcome assessment allocation in order for outcome collection to occur. When possible, outcome group assignment will not be shared with the epilepsy provider managing the participant, in an effort to reduce any potential bias in retention that could be introduced by the provider in clinical interactions with the participant.
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
- •Age 18 or older
- •Completed electronic questionnaires independently in clinic
- •Epilepsy diagnosis (clinician impression or EEG-based)
- •Borderline or high anxiety or depression symptoms at baseline
- •GAD-7 score > 7 (anxiety)
- •NDDI-E score > 13 (depression)
排除标准
- •Passive suicidal ideation (NDDI-E item 4 score of 3 or 4)
- •Age <18 years
研究组 & 干预措施
EMR Group
Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.
干预措施: EMR-based-interventional method (Other)
Phone Group
Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.
干预措施: Telephone-based-standard method (Other)
结局指标
主要结局
Percentage of Participants Retained in the Study in the EMR Arm
时间窗: 6 months
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR
次要结局
- Percentage of Participants Retained in the Study in the Phone Arm(6 months)
- Quality of Life in Epilepsy-10 (QOLIE-10)(6 Months)
- Generalized Anxiety Disorder 7-item (GAD-7) Scale(6 months)
- Neurological Disorders Depression Inventory (NDDI-E)(6 Months)
- Quality of Life in Epilepsy-10 (QOLIE-10)(Baseline)
- Quality of Life in Epilepsy-10 (QOLIE-10)(3 Months)
- Generalized Anxiety Disorder 7-item (GAD-7) Scale(Baseline)
- Generalized Anxiety Disorder 7-item (GAD-7) Scale(3 Months)
- Neurological Disorders Depression Inventory (NDDI-E)(Baseline)
- Neurological Disorders Depression Inventory (NDDI-E)(3 Months)