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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03879525
Other study ID # IRB00056740
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 16, 2019
Est. completion date September 27, 2021

Study information

Verified date September 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 27, 2021
Est. primary completion date November 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
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.
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.

Locations

Country Name City State
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Semi-Structured Interviews 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
Primary 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 6 months
Secondary 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 6 months
Secondary 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. Baseline
Secondary 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. 3 Months
Secondary 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. 6 Months
Secondary Generalized Anxiety Disorder 7-item (GAD-7) Scale Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. Baseline
Secondary Generalized Anxiety Disorder 7-item (GAD-7) Scale Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. 3 Months
Secondary Generalized Anxiety Disorder 7-item (GAD-7) Scale Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. 6 months
Secondary 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. Baseline
Secondary 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. 3 Months
Secondary 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. 6 Months
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