Clinical trial NCT03879525: EMR Outcomes: Anxiety and Depression in Epilepsy
Official title: Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Anxiety
Depression
Epilepsy
Keywords: Electronic medical record
EMR
Patient Outcomes
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of Participants Retained in the Study in the EMR Arm
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants Retained in the Study in the Phone Arm
timeFrame: 6 months
measure: Quality of Life in Epilepsy-10 (QOLIE-10)
timeFrame: Baseline
measure: Quality of Life in Epilepsy-10 (QOLIE-10)
timeFrame: 3 Months
measure: Quality of Life in Epilepsy-10 (QOLIE-10)
timeFrame: 6 Months
measure: Generalized Anxiety Disorder 7-item (GAD-7) Scale
timeFrame: Baseline
measure: Generalized Anxiety Disorder 7-item (GAD-7) Scale
timeFrame: 3 Months
measure: Generalized Anxiety Disorder 7-item (GAD-7) Scale
timeFrame: 6 months
measure: Neurological Disorders Depression Inventory (NDDI-E)
timeFrame: Baseline
measure: Neurological Disorders Depression Inventory (NDDI-E)
timeFrame: 3 Months
measure: Neurological Disorders Depression Inventory (NDDI-E)
timeFrame: 6 Months
Other outcomes:
measure: Semi-Structured Interviews
timeFrame: 13 Months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi M. Munger Clary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: