EMR Outcomes: Anxiety and Depression in Epilepsy

Wake Forest University (WFU)

Status: Completed

Conditions: Epilepsy; Quality of Life; Depression; Anxiety

Treatments: Other: Telephone-based-standard method; Other: EMR-based-interventional method

Study type: Interventional

Funder types: Other

Identifiers

NCT03879525

IRB00056740

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

EMR Group

Experimental group

Description:

Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.

Treatment:

Other: EMR-based-interventional method

Phone Group

Active Comparator group

Description:

Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.

Treatment:

Other: Telephone-based-standard method