NCT03879525

EMR Outcomes: Anxiety and Depression in Epilepsy

Completed NA Results posted Last updated 18 January 2022

What this trial tests

NA trial testing EMR-based-interventional method in Quality of Life in 30 participants. Completed in 27 September 2021.

Timeline

16 December 2019

Primary endpoint
10 November 2020

27 September 2021

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	30
Start date	16 December 2019
Primary completion	10 November 2020
Estimated completion	27 September 2021
Sites	1 location across United States

Drugs / interventions tested

• EMR-based-interventional method
• Telephone-based-standard method

Conditions studied

• Quality of Life — all drugs for Quality of Life →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →
• Epilepsy — all drugs for Epilepsy →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Quality of Life or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Retained in the Study in the EMR Arm Primary · 6 months

Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR

Group	Value	95% CI
EMR Group	67

Percentage of Participants Retained in the Study in the Phone Arm Secondary · 6 months

Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone

Group	Value	95% CI
Phone Group	100

Quality of Life in Epilepsy-10 (QOLIE-10) Secondary · 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.

Group	Value	95% CI
EMR Group	53.3	± 16.6
Phone Group	60.5	± 18.6

Quality of Life in Epilepsy-10 (QOLIE-10) Secondary · 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.

Group	Value	95% CI
EMR Group	61.0	± 18.6
Phone Group	57.3	± 15.7

Quality of Life in Epilepsy-10 (QOLIE-10) Secondary · 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.

Group	Value	95% CI
EMR Group	57.6	± 20.3
Phone Group	62.6	± 16.7

Generalized Anxiety Disorder 7-item (GAD-7) Scale Secondary · Baseline

Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

Group	Value	95% CI
EMR Group	10.5	± 5.3
Phone Group	10.5	± 3.8

Generalized Anxiety Disorder 7-item (GAD-7) Scale Secondary · 3 Months

Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

Group	Value	95% CI
EMR Group	6.0	± 3.0
Phone Group	10.2	± 4.2

Generalized Anxiety Disorder 7-item (GAD-7) Scale Secondary · 6 months

Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

Group	Value	95% CI
EMR Group	7.7	± 5.4
Phone Group	8.5	± 5.0

Neurological Disorders Depression Inventory (NDDI-E) Secondary · 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.

Group	Value	95% CI
EMR Group	15.4	± 2.8
Phone Group	15.3	± 3.4

Neurological Disorders Depression Inventory (NDDI-E) Secondary · 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.

Group	Value	95% CI
EMR Group	15.4	± 3.1
Phone Group	15.0	± 2.6

Neurological Disorders Depression Inventory (NDDI-E) Secondary · 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.

Group	Value	95% CI
EMR Group	14.7	± 3.9
Phone Group	13.8	± 3.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through 6 month follow up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

EMR Group

Serious: 2/15 (13%)

Deaths: 0/15

Phone Group

Serious: 0/15 (0%)

Deaths: 0/15

Serious adverse events (1 terms)

Reaction	System	EMR Group	Phone Group
status epilepticus	Nervous system disorders	—	—

Most-reported serious reactions: status epilepticus.

Data from ClinicalTrials.gov NCT03879525 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient-reported outcomes via electronic health record portal versus telephone: a pragmatic randomized pilot trial of anxiety or depression symptoms in epilepsy.
   Munger Clary HM, Snively BM, Topaloglu U, Duncan P, et al · · 2022 · cited 8× · PMID 36247085 · DOI 10.1093/jamiaopen/ooac052
2. Quality of life during usual epilepsy care for anxiety or depression symptoms: Secondary patient-reported outcomes in a randomized trial of remote assessment methods.
   Munger Clary HM, Snively BM, Kumi-Ansu Y, Alexander HB, et al · · 2024 · cited 4× · PMID 38908323 · DOI 10.1016/j.eplepsyres.2024.107396
3. Implementing electronic health record-based anxiety and depression screening in an epilepsy clinic: Theory-based implementation strategy and pre-post quantitative outcomes using Reach, Effectiveness, Adoption, Implementation, and Maintenance.
   Munger Clary HM, Alexander HB, Gesell S, Wan M, et al · · 2025 · PMID 40529000 · DOI 10.1017/cts.2025.74