EMR Outcomes: Anxiety and Depression in Epilepsy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2021-09-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Quality of Life Anxiety Depression Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Outcome group assignment will not be blinded to the primary investigator or primary study coordinator, as it will be necessary for these individuals to know outcome assessment allocation in order for outcome collection to occur. When possible, outcome group assignment will not be shared with the epilepsy provider managing the participant, in an effort to reduce any potential bias in retention that could be introduced by the provider in clinical interactions with the participant.

Study Groups

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EMR Group

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

Group Type EXPERIMENTAL

EMR-based-interventional method

Intervention Type OTHER

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.

Phone Group

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

Group Type ACTIVE_COMPARATOR

Telephone-based-standard method

Intervention Type OTHER

Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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)