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Completed

NCT Number: NCT03879525

EMR Outcomes: Anxiety and Depression in Epilepsy

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.

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Key information

Conditions

Quality of Life Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Epilepsy Mental Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMR-based-interventional method

Other

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

Other

Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Generalized Anxiety Disorder 7-item (GAD-7) Scale

    Time frame: Baseline

    Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

  6. Generalized Anxiety Disorder 7-item (GAD-7) Scale

    Time frame: 3 Months

    Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

  7. Generalized Anxiety Disorder 7-item (GAD-7) Scale

    Time frame: 6 months

    Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.

  8. 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.

  9. 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.

  10. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 18, 2019
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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