EMR Outcomes: Anxiety and Depression in Epilepsy

Not Applicable

Completed

• Conditions: Depression; Anxiety; Quality of Life; Epilepsy

• Registration Number: NCT03879525
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Study Start: 2019-12-16
• Primary Completion: 2020-11-10
• Status Verified: 2021-09
• Study Completion: 2021-09-27
• Results First Submitted: 2021-11-08
• Results First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Results First Posted: 2022-01-18
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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)

Exclusion Criteria

• Passive suicidal ideation (NDDI-E item 4 score of 3 or 4)
• Age <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Retained in the Study in the EMR Arm	6 months	Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Retained in the Study in the Phone Arm	6 months	Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone
Quality of Life in Epilepsy-10 (QOLIE-10)	6 Months	QOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy. Total Score 0-100. Higher scores denotes worse outcomes.
Generalized Anxiety Disorder 7-item (GAD-7) Scale	6 months	Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Neurological Disorders Depression Inventory (NDDI-E)	6 Months	The NDDI-E is a 6-item questionnaire validated to screen for depression in people with epilepsy. Total Score 4-24. Higher scores denotes worse outcomes.

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States