EpilepsyNCT05864612
Tools for Anxiety and Depression Screening in Epilepsy
A study testing Screening Questionnaires in people with Epilepsy, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Screening Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site
Who cannot join
- No exclusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Developing Interoperable 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.
Read the 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. An exploratory supplement randomizing individuals to text message versus email survey link was later added.
- Conditions
- Epilepsy
- Being tested
- Screening Questionnaires
- Keywords
- anxiety, depression, screening tools
- Medical subject headings
- Epilepsy, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening QuestionnairesBehavioural
Standard care screening questionnaires on anxiety and depression
| Study group | Role | What they receive |
|---|---|---|
| Text Message | Active comparator | Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message. Receives: Behavioral: Screening Questionnaires |
| Customized Email Prompt | Active comparator | 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. Receives: Behavioral: Screening Questionnaires |
| Generic Electronic Health Record (EHR) portal email | Active comparator | Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal. Receives: Behavioral: Screening Questionnaires |
| EHR Portal with No Message | Active comparator | Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal. Receives: Behavioral: Screening Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1
Secondary outcomes (4)
Research Team Time-sending Instruments
Time in minutes will be recorded
Measured: Baseline Day 0
Research Team Time-instrument Data Entry
Time in minutes will be recorded
Measured: Week 1
Participant Time From Instrument Delivery to Completion
Time in minutes will be recorded
Measured: Week 1
Percent Accuracy of Kit Application Programming Interface (API)
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.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start20 Sep 2023
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Heidi M. Munger Clary, MD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864612
- Sponsor's protocol ID
- IRB00086172
- Other IDs
- R03TR004251
- Status last verified
- Sep 2024
- First submitted
- 9 May 2023
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Interoperable Tools for Anxiety and Depression Screening in Epilepsy
- ClinicalTrials.gov ID
- NCT05864612
- Acronym / sponsor ID
- IRB00086172
- Conditions
- Epilepsy
- Keywords
- anxiety, depression, screening tools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. An exploratory supplement randomizing individuals to text message versus email survey link was later added.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Text Message | Active comparator | Behavioral: Screening QuestionnairesSubjects 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 comparator | Behavioral: Screening QuestionnairesSubjects 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 comparator | Behavioral: Screening QuestionnairesSubjects in this arm will be prompted with customized EHR portal message after login to EHR portal. |
| EHR Portal with No Message | Active comparator | Behavioral: Screening QuestionnairesSubjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Visit scheduled 7 days in advance at an adult-focused epilepsy clinic at the study site
Key exclusion criteria (1 listed)
- No exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening QuestionnairesStandard care screening questionnaires on anxiety and depression | Behavioural | Customized Email Prompt, EHR Portal with No Message, Generic Electronic Health Record (EHR) portal email, Text Message |
Primary outcome
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.
4 secondary outcomes
Research Team Time-sending Instruments
Time frame: Baseline Day 0
Research Team Time-instrument Data Entry
Time frame: Week 1
Participant Time From Instrument Delivery to Completion
Time frame: Week 1
Percent Accuracy of Kit Application Programming Interface (API)
Time frame: Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi M. Munger Clary, MD, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Questionnaires in people with Epilepsy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Completing Screening Instruments (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.