EMR Outcomes: Anxiety and Depression in Epilepsy
Primary Purpose
Quality of Life, Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMR-based-interventional method
Telephone-based-standard method
Sponsored by
About this trial
This is an interventional supportive care trial for Quality of Life focused on measuring Electronic medical record, EMR, Patient Outcomes
Eligibility Criteria
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
Sites / Locations
- Wake Forest Baptist Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EMR Group
Phone Group
Arm Description
Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.
Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.
Outcomes
Primary Outcome Measures
Percentage of Participants Retained in the Study in the EMR Arm
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR
Secondary Outcome Measures
Percentage of Participants Retained in the Study in the Phone Arm
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone
Quality of Life in Epilepsy-10 (QOLIE-10)
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.
Quality of Life in Epilepsy-10 (QOLIE-10)
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.
Quality of Life in Epilepsy-10 (QOLIE-10)
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.
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Neurological Disorders Depression Inventory (NDDI-E)
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.
Neurological Disorders Depression Inventory (NDDI-E)
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.
Neurological Disorders Depression Inventory (NDDI-E)
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.
Full Information
NCT ID
NCT03879525
First Posted
March 15, 2019
Last Updated
January 13, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03879525
Brief Title
EMR Outcomes: Anxiety and Depression in Epilepsy
Official Title
Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
November 10, 2020 (Actual)
Study Completion Date
September 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
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
The purpose of this research is to find out how people with epilepsy and possible symptoms of anxiety or depression are doing for 6 months after a regular epilepsy clinic visit. Participants in this study will complete questionnaires either by phone or via the patient portal.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Anxiety, Depression, Epilepsy
Keywords
Electronic medical record, EMR, Patient Outcomes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome group assignment will not be blinded to the primary investigator or primary study coordinator, as it will be necessary for these individuals to know outcome assessment allocation in order for outcome collection to occur. When possible, outcome group assignment will not be shared with the epilepsy provider managing the participant, in an effort to reduce any potential bias in retention that could be introduced by the provider in clinical interactions with the participant.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMR Group
Arm Type
Experimental
Arm Description
Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.
Arm Title
Phone Group
Arm Type
Active Comparator
Arm Description
Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.
Intervention Type
Other
Intervention Name(s)
EMR-based-interventional method
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Telephone-based-standard method
Intervention Description
Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
Primary Outcome Measure Information:
Title
Percentage of Participants Retained in the Study in the EMR Arm
Description
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Retained in the Study in the Phone Arm
Description
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone
Time Frame
6 months
Title
Quality of Life in Epilepsy-10 (QOLIE-10)
Description
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.
Time Frame
Baseline
Title
Quality of Life in Epilepsy-10 (QOLIE-10)
Description
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.
Time Frame
3 Months
Title
Quality of Life in Epilepsy-10 (QOLIE-10)
Description
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.
Time Frame
6 Months
Title
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Description
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time Frame
Baseline
Title
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Description
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time Frame
3 Months
Title
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Description
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time Frame
6 months
Title
Neurological Disorders Depression Inventory (NDDI-E)
Description
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.
Time Frame
Baseline
Title
Neurological Disorders Depression Inventory (NDDI-E)
Description
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.
Time Frame
3 Months
Title
Neurological Disorders Depression Inventory (NDDI-E)
Description
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.
Time Frame
6 Months
Other Pre-specified Outcome Measures:
Title
Semi-Structured Interviews
Description
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.
Time Frame
13 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Will consider requests if received.
Learn more about this trial
EMR Outcomes: Anxiety and Depression in Epilepsy
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