- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879525
EMR Outcomes: Anxiety and Depression in Epilepsy
Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a study among N=30 individuals with epilepsy and high or borderline anxiety or depression symptoms receiving usual care at the Wake Forest Comprehensive Epilepsy Center. Participants are randomized to one of two outcome assessment methods [Electronic Medical Record (EMR)-based-interventional method vs. telephone-based-standard method] for collecting quality of life, anxiety and depression outcomes at 3 and 6 months, under usual care management.
The primary aim of the study is to assess feasibility of EMR-based outcome assessment by measuring 6-month retention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 or older
- Completed electronic questionnaires independently in clinic
- Epilepsy diagnosis (clinician impression or EEG-based)
- Borderline or high anxiety or depression symptoms at baseline
- GAD-7 score > 7 (anxiety)
- NDDI-E score > 13 (depression)
Exclusion Criteria:
- Passive suicidal ideation (NDDI-E item 4 score of 3 or 4)
- Age <18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EMR Group
Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.
|
Questionnaire delivery method.
Participants will complete standard care anxiety and depression screening and quality of life assessment directly into the patient entered section of the EMR, administered on arrival in the clinic.
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Active Comparator: Phone Group
Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.
|
Questionnaires delivered via phone.
Participants will complete standard care anxiety and depression screening and quality of life assessment via phone.
Standard delivery method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Retained in the Study in the EMR Arm
Time Frame: 6 months
|
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Retained in the Study in the Phone Arm
Time Frame: 6 months
|
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone
|
6 months
|
Quality of Life in Epilepsy-10 (QOLIE-10)
Time Frame: Baseline
|
QOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy.
Total Score 0-100.
Higher scores denotes worse outcomes.
|
Baseline
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Quality of Life in Epilepsy-10 (QOLIE-10)
Time Frame: 3 Months
|
QOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy.
Total Score 0-100.
Higher scores denotes worse outcomes.
|
3 Months
|
Quality of Life in Epilepsy-10 (QOLIE-10)
Time Frame: 6 Months
|
QOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy.
Total Score 0-100.
Higher scores denotes worse outcomes.
|
6 Months
|
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time Frame: Baseline
|
Anxiety scale.
Total Score 0-28.
Higher scores denotes worse outcomes.
|
Baseline
|
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time Frame: 3 Months
|
Anxiety scale.
Total Score 0-28.
Higher scores denotes worse outcomes.
|
3 Months
|
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time Frame: 6 months
|
Anxiety scale.
Total Score 0-28.
Higher scores denotes worse outcomes.
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6 months
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Neurological Disorders Depression Inventory (NDDI-E)
Time Frame: Baseline
|
The NDDI-E is a 6-item questionnaire validated to screen for depression in people with epilepsy.
Total Score 4-24.
Higher scores denotes worse outcomes.
|
Baseline
|
Neurological Disorders Depression Inventory (NDDI-E)
Time Frame: 3 Months
|
The NDDI-E is a 6-item questionnaire validated to screen for depression in people with epilepsy.
Total Score 4-24.
Higher scores denotes worse outcomes.
|
3 Months
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Neurological Disorders Depression Inventory (NDDI-E)
Time Frame: 6 Months
|
The NDDI-E is a 6-item questionnaire validated to screen for depression in people with epilepsy.
Total Score 4-24.
Higher scores denotes worse outcomes.
|
6 Months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Semi-Structured Interviews
Time Frame: 13 Months
|
Optional semi-structured interviews to assess patient-level barriers and facilitators to successfully implementing a collaborative care model of mental health care.
Data will be analyzed via an inductive thematic analysis approach.
|
13 Months
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Collaborators and Investigators
Investigators
- Principal Investigator: Heidi M. Munger Clary, MD, MPH, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00056740
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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