EMR Outcomes: Anxiety and Depression in Epilepsy

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879525
• Other study ID #: IRB00056740
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 27, 2021
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Epilepsy
• Quality of Life

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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