Tools for Anxiety and Depression Screening in Epilepsy
Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy
2 other identifiers
interventional
880
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
September 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2024
CompletedResults Posted
Study results publicly available
October 30, 2025
CompletedOctober 30, 2025
September 1, 2024
12 months
May 9, 2023
July 9, 2025
October 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Completing Screening Instruments
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.
Week 1
Secondary Outcomes (4)
Research Team Time-sending Instruments
Baseline Day 0
Research Team Time-instrument Data Entry
Week 1
Participant Time From Instrument Delivery to Completion
Week 1
Percent Accuracy of Kit Application Programming Interface (API)
Week 1
Other Outcomes (4)
Clinic Visit Attendance:Visit Completed
Week 1
Clinic Visit Attendance:Visit Canceled
Week 1
Clinic Visit Attendance: No-show
Week 1
- +1 more other outcomes
Study Arms (4)
Text Message
ACTIVE COMPARATORSubjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Customized Email Prompt
ACTIVE COMPARATORSubjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by an email with a REDCap email survey link.
Generic Electronic Health Record (EHR) portal email
ACTIVE COMPARATORSubjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
EHR Portal with No Message
ACTIVE COMPARATORSubjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Interventions
Standard care screening questionnaires on anxiety and depression
Eligibility Criteria
You may qualify if:
- Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Heidi Munger-Clary, MD, MPH, FACNS, FAES
- Organization
- Wake Forest University Health Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi M. Munger Clary, MD, MPH
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2023
First Posted
May 18, 2023
Study Start
September 20, 2023
Primary Completion
September 3, 2024
Study Completion
September 3, 2024
Last Updated
October 30, 2025
Results First Posted
October 30, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- After the study is completed and results published, de-identified, archived data will be available upon request.
After the study is completed and results published by primary study team, de-identified, archived data will be stored for potential use if requested by other qualified researchers including those outside of the study.