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Screening Tools for Anxiety and Depression in Epilepsy
N/A
Recruiting
Led By Heidi M. Munger Clary, MD, MPH
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1
Awards & highlights
Summary
This trial compares how well patients complete anxiety & depression assessments when using different methods, to see if the completion rate varies.
Who is the study for?
This trial is for adults with epilepsy who have a clinic visit scheduled at least 7 days in advance. There are no specific exclusions, meaning it's open to anyone meeting the inclusion criteria.
What is being tested?
The study is testing how well patients complete anxiety and depression questionnaires using different methods: REDCap versus Electronic Health Record (EHR) systems. It aims to see if one method leads to better completion rates.
What are the potential side effects?
Since this trial involves completing screening questionnaires rather than medication or medical procedures, there are no direct side effects associated with the interventions being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Screening completion - Yes or No
Secondary study objectives
Accuracy of Kit Application Programming Interface (API)
Participant time from instrument delivery to completion
Research team time-instrument data entry
+1 moreOther study objectives
Clinic visit attendance: no-show
Clinic visit attendance:Visit canceled
Clinic visit attendance:Visit completed
+1 moreTrial Design
4Treatment groups
Active Control
Group I: Customized Email PromptActive Control1 Intervention
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.
Group II: Text MessageActive Control1 Intervention
Subjects in this arm will be asked to complete standard care screening questionnaires on anxiety and depression, delivered by Twilio text message.
Group III: Generic Electronic Health Record (EHR) portal emailActive Control1 Intervention
Subjects in this arm will be prompted with customized EHR portal message after login to EHR portal.
Group IV: EHR Portal with No MessageActive Control1 Intervention
Subjects in this arm will not receive a reminder, but previsit questionnaires associated with a visit will be in their EHR portal.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,012,827 Total Patients Enrolled
9 Trials studying Epilepsy
465 Patients Enrolled for Epilepsy
National Center for Advancing Translational Sciences (NCATS)NIH
342 Previous Clinical Trials
409,588 Total Patients Enrolled
1 Trials studying Epilepsy
30,000 Patients Enrolled for Epilepsy
Heidi M. Munger Clary, MD, MPHPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
90 Total Patients Enrolled
2 Trials studying Epilepsy
90 Patients Enrolled for Epilepsy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an appointment at the epilepsy clinic in 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: Customized Email Prompt
- Group 2: Text Message
- Group 3: Generic Electronic Health Record (EHR) portal email
- Group 4: EHR Portal with No Message
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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