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Clinical Trials/NCT03879525
NCT03879525
Completed
Not Applicable

Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)

Wake Forest University Health Sciences1 site in 1 country30 target enrollmentDecember 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Wake Forest University Health Sciences
Enrollment
30
Locations
1
Primary Endpoint
Percentage of Participants Retained in the Study in the EMR Arm
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 16, 2019
End Date
September 27, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of Participants Retained in the Study in the EMR Arm

Time Frame: 6 months

Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR

Secondary Outcomes

  • 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)

Study Sites (1)

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