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Tools for Anxiety and Depression Screening in Epilepsy

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening Questionnaires
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring anxiety, depression, screening tools

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site Exclusion Criteria: No exclusions

Sites / Locations

  • Atrium Health Wake Forest BaptistRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Text Message

Customized Email Prompt

Generic Electronic Health Record (EHR) portal email

EHR Portal with No Message

Arm Description

Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.

Subjects 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.

Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.

Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Research team time-sending instruments
Time in minutes will be recorded
Research team time-instrument data entry
Time in minutes will be recorded
Participant time from instrument delivery to completion
Time in minutes will be recorded
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.

Full Information

First Posted
May 9, 2023
Last Updated
October 4, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05864612
Brief Title
Tools for Anxiety and Depression Screening in Epilepsy
Official Title
Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
anxiety, depression, screening tools

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The four instrument delivery methods to be used in this pragmatic trial represent distinct prompts & cues for screening instrument completion. Examining these multiple instrument delivery methods will generate outputs that will support flexibility in instrument delivery modalities across multiple sites in future multicenter studies in this area. These 4 distinct delivery methods are used to deliver identical standard care validated anxiety and depression screening instruments.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Text Message
Arm Type
Active Comparator
Arm Description
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Arm Title
Customized Email Prompt
Arm Type
Active Comparator
Arm Description
Subjects 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.
Arm Title
Generic Electronic Health Record (EHR) portal email
Arm Type
Active Comparator
Arm Description
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Arm Title
EHR Portal with No Message
Arm Type
Active Comparator
Arm Description
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Intervention Type
Behavioral
Intervention Name(s)
Screening Questionnaires
Intervention Description
Standard care screening questionnaires on anxiety and depression
Primary Outcome Measure Information:
Title
Screening completion - Yes or No
Description
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.
Time Frame
Week 1
Secondary Outcome Measure Information:
Title
Research team time-sending instruments
Description
Time in minutes will be recorded
Time Frame
Baseline Day 0
Title
Research team time-instrument data entry
Description
Time in minutes will be recorded
Time Frame
Week 1
Title
Participant time from instrument delivery to completion
Description
Time in minutes will be recorded
Time Frame
Week 1
Title
Accuracy of Kit Application Programming Interface (API)
Description
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.
Time Frame
Week 1
Other Pre-specified Outcome Measures:
Title
Clinic visit attendance:Visit completed
Description
Number of visits completed out of number scheduled
Time Frame
Week 1
Title
Clinic visit attendance:Visit canceled
Description
Number of visits completed out of number scheduled
Time Frame
Week 1
Title
Clinic visit attendance: no-show
Description
Number of no-show visits out of number scheduled
Time Frame
Week 1
Title
Time For Data Entry
Description
Time collected in minutes
Time Frame
Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site Exclusion Criteria: No exclusions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi M. Munger Clary, MD, MPH
Phone
336-716-7110
Email
hmungerc@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi M. Munger Clary, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi M. Munger Clary, MD, MPH
Phone
336-716-7110
Email
hmungerc@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Heidi M. Munger Clary, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After the study is completed and results published, de-identified, archived data will be available upon request.

Learn more about this trial

Tools for Anxiety and Depression Screening in Epilepsy

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