Tools for Anxiety and Depression Screening in Epilepsy

Epilepsy Clinical Trial

Official title:

Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864612
• Other study ID #: IRB00086172
• Secondary ID: R03TR004251
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Heidi M. Munger Clary, MD, MPH
• Phone: 336-716-7110
• Email: hmungerc[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusions

Related Conditions & MeSH terms

• Depression
• Epilepsy

Intervention

Behavioral:
• Screening Questionnaires
Standard care screening questionnaires on anxiety and depression

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinic visit attendance:Visit completed	Number of visits completed out of number scheduled	Week 1
Other	Clinic visit attendance:Visit canceled	Number of visits completed out of number scheduled	Week 1
Other	Clinic visit attendance: no-show	Number of no-show visits out of number scheduled	Week 1
Other	Time For Data Entry	Time collected in minutes	Week 1
Primary	Screening completion - Yes or No	Proportion of screening instruments completed 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	Research team time-sending instruments	Time in minutes will be recorded	Baseline Day 0
Secondary	Research team time-instrument data entry	Time in minutes will be recorded	Week 1
Secondary	Participant time from instrument delivery to completion	Time in minutes will be recorded	Week 1
Secondary	Accuracy of Kit Application Programming Interface (API)	This will provide key information about whether a Kit API REDCap data collection may improve accuracy of EHR-based data collection compared to manual collection.	Week 1