Skip to main content
OpenTrials
Completed

NCT Number: NCT05864612

Tools for Anxiety and Depression Screening in Epilepsy

A randomized trial to compare patient-completion success of REDCap and Electronic Health Record (EHR)-based anxiety & depression instrument delivery methods. Study hypothesis is that the screening completion proportion will vary across the 4 modalities tested.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Mental Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

In this randomized study of four modalities, we will compare Twilio text message delivery via REDCap versus (vs.) REDCap email survey links vs. EHR portal questionnaires with reminder message vs. current standard delivery EHR portal questionnaires without reminder. Screening instruments will be delivered by randomized method 7 days prior to scheduled clinic visit and outcomes occur by the time of the scheduled clinic visit. The study setting is the Wake Forest Comprehensive Epilepsy Center, with 2 clinic sites where adult patients are served (Atrium Health Wake Forest Baptist main campus, Atrium Health High Point Medical Center). EHR portal questionnaires without reminder is the current standard care screener delivery method. An exploratory supplement randomizing individuals to text message versus email survey link was later added.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site

Exclusion criteria

  • No exclusions

Treatment and study plan

Screening Questionnaires

Behavioral

Standard care screening questionnaires on anxiety and depression

Primary outcomes

  1. Percentage of Subjects Completing Screening Instruments

    Time frame: Week 1

    Percentage of subjects completing screening instruments by each of the 4 methods prior to clinic visit will be used to compare the effect of the different methods on patient self-completion, and to estimate completion rates by different methods for use in future screening implementation trials.

Secondary outcomes

  1. Research Team Time-sending Instruments

    Time frame: Baseline Day 0

    Time in minutes will be recorded

  2. Research Team Time-instrument Data Entry

    Time frame: Week 1

    Time in minutes will be recorded

  3. Participant Time From Instrument Delivery to Completion

    Time frame: Week 1

    Time in minutes will be recorded

  4. Percent Accuracy of Kit Application Programming Interface (API)

    Time frame: Week 1

    Among participants who completed anxiety and depression screening instruments by one of the two EHR methods, this measure evaluates the % of instrument scores collected via Kit API that were identical to the original EHR source completion.

Other outcomes

  1. Clinic Visit Attendance:Visit Completed

    Time frame: Week 1

    Number of visits completed out of number scheduled

  2. Clinic Visit Attendance:Visit Canceled

    Time frame: Week 1

    Number of visits completed out of number scheduled

  3. Clinic Visit Attendance: No-show

    Time frame: Week 1

    Number of no-show visits out of number scheduled

  4. Time For Data Entry

    Time frame: Week 1

    Time collected in minutes

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 18, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.