Trial Outcomes & Findings for Tools for Anxiety and Depression Screening in Epilepsy (NCT NCT05864612)
NCT ID: NCT05864612
Last Updated: 2025-10-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
880 participants
Primary outcome timeframe
Week 1
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
Text Message
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Customized Email Prompt
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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Generic Electronic Health Record (EHR) Portal Email
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Electronic Health Record (EHR) Portal With No Message
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
221
|
221
|
219
|
219
|
|
Overall Study
COMPLETED
|
221
|
221
|
219
|
219
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tools for Anxiety and Depression Screening in Epilepsy
Baseline characteristics by cohort
| Measure |
Text Message
n=221 Participants
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Customized Email Prompt
n=221 Participants
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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Generic Electronic Health Record (EHR) Portal Email
n=219 Participants
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
EHR Portal With No Message
n=219 Participants
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Total
n=880 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
213 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
824 Participants
n=21 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 16.6 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 18.1 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 17.1 • n=4 Participants
|
42.7 years
STANDARD_DEVIATION 17.2 • n=21 Participants
|
|
Sex/Gender, Customized
male
|
93 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
389 Participants
n=21 Participants
|
|
Sex/Gender, Customized
female
|
128 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
488 Participants
n=21 Participants
|
|
Sex/Gender, Customized
unknown
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
173 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
643 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 1Percentage 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.
Outcome measures
| Measure |
Text Message
n=221 Participants
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
EHR Portal With No Message
n=219 Participants
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Customized Email Prompt
n=221 Participants
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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Generic Electronic Health Record (EHR) Portal Email
n=219 Participants
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
|---|---|---|---|---|
|
Percentage of Subjects Completing Screening Instruments
|
0 Percentage who completed
|
12 Percentage who completed
|
14 Percentage who completed
|
19 Percentage who completed
|
SECONDARY outcome
Timeframe: Baseline Day 0Time in minutes will be recorded
Outcome measures
| Measure |
Text Message
n=221 Participants
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
EHR Portal With No Message
n=219 Participants
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Customized Email Prompt
n=221 Participants
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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Generic Electronic Health Record (EHR) Portal Email
n=219 Participants
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
|---|---|---|---|---|
|
Research Team Time-sending Instruments
|
3.0 minutes
Standard Deviation 1.6
|
0.6 minutes
Standard Deviation 0.6
|
4.5 minutes
Standard Deviation 1.8
|
1.7 minutes
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Week 1Population: no responses received in Text Message Arm due to technical error in text delivery occurring outside of REDCap text sending interface
Time in minutes will be recorded
Outcome measures
| Measure |
Text Message
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
EHR Portal With No Message
n=27 Participants
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Customized Email Prompt
n=29 Participants
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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Generic Electronic Health Record (EHR) Portal Email
n=43 Participants
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
|---|---|---|---|---|
|
Research Team Time-instrument Data Entry
|
—
|
1.7 minutes
Standard Deviation 2.4
|
2.5 minutes
Standard Deviation 2.0
|
1.8 minutes
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Week 1Population: no responses received due to technical error in text delivery occurring outside of REDCap text sending interface - number of participants with instrument responses received - number of participants with instrument responses received - number of participants with instrument responses received
Time in minutes will be recorded
Outcome measures
| Measure |
Text Message
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
EHR Portal With No Message
n=27 Participants
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Customized Email Prompt
n=32 Participants
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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Generic Electronic Health Record (EHR) Portal Email
n=42 Participants
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
|---|---|---|---|---|
|
Participant Time From Instrument Delivery to Completion
|
—
|
2.2 minutes
Standard Deviation 2.1
|
4.6 minutes
Standard Deviation 2.4
|
3.1 minutes
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Week 1Population: The analysis population for this outcome measure (accuracy of Kit API) is only participants randomized to one of the two EHR portal arms who also completed the pre-visit questionnaires and thus had questionnaires completed in the electronic health record available for testing Kit API data collection accuracy, as this tool is designed to collect data directly from the health record into REDCap.
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.
Outcome measures
| Measure |
Text Message
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
EHR Portal With No Message
n=27 Participants
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Customized Email Prompt
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.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
Generic Electronic Health Record (EHR) Portal Email
n=43 Participants
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Screening Questionnaires: Standard care screening questionnaires on anxiety and depression
|
|---|---|---|---|---|
|
Percent Accuracy of Kit Application Programming Interface (API)
|
—
|
100 percent scores identical to EHR source
Interval 100.0 to 100.0
|
—
|
100 percent scores identical to EHR source
Interval 100.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1Number of visits completed out of number scheduled
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1Number of visits completed out of number scheduled
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1Number of no-show visits out of number scheduled
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1Time collected in minutes
Outcome measures
Outcome data not reported
Adverse Events
Text Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Customized Email Prompt
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Generic Electronic Health Record (EHR) Portal Email
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EHR Portal With No Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Heidi Munger-Clary, MD, MPH, FACNS, FAES
Wake Forest University Health Sciences
Phone: 336-716-7110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place