EMR Outcomes: Anxiety and Depression in Epilepsy

January 13, 2022 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMR Group
Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.
Questionnaire delivery method. Participants will complete standard care anxiety and depression screening and quality of life assessment directly into the patient entered section of the EMR, administered on arrival in the clinic.
Active Comparator: Phone Group
Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.
Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Retained in the Study in the Phone Arm
Time Frame: 6 months
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone
6 months
Quality of Life in Epilepsy-10 (QOLIE-10)
Time Frame: Baseline
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.
Baseline
Quality of Life in Epilepsy-10 (QOLIE-10)
Time Frame: 3 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.
3 Months
Quality of Life in Epilepsy-10 (QOLIE-10)
Time Frame: 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.
6 Months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time Frame: Baseline
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Baseline
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time Frame: 3 Months
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
3 Months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time Frame: 6 months
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
6 months
Neurological Disorders Depression Inventory (NDDI-E)
Time Frame: Baseline
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.
Baseline
Neurological Disorders Depression Inventory (NDDI-E)
Time Frame: 3 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.
3 Months
Neurological Disorders Depression Inventory (NDDI-E)
Time Frame: 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.
6 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-Structured Interviews
Time Frame: 13 Months
Optional semi-structured interviews to assess patient-level barriers and facilitators to successfully implementing a collaborative care model of mental health care. Data will be analyzed via an inductive thematic analysis approach.
13 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Heidi M. Munger Clary, MD, MPH, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2019

Primary Completion (Actual)

November 10, 2020

Study Completion (Actual)

September 27, 2021

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will consider requests if received.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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