EMR Outcomes: Anxiety and Depression in Epilepsy

NCT03879525 | Completed Results

• 1 other identifier: IRB00056740
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Anxiety; Depression; Epilepsy

Keywords

Electronic medical record; EMR; Patient Outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Percentage of Participants Retained in the Study in the Phone Arm

  6 months

• Quality of Life in Epilepsy-10 (QOLIE-10)

  Baseline

• Quality of Life in Epilepsy-10 (QOLIE-10)

  3 Months

• Quality of Life in Epilepsy-10 (QOLIE-10)

  6 Months

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

  Baseline

Other Outcomes (1)

• Semi-Structured Interviews

  13 Months

Study Arms (2)

EMR Group

EXPERIMENTAL

Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method.

Other: EMR-based-interventional method

Phone Group

ACTIVE COMPARATOR

Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method.

Other: Telephone-based-standard method

Interventions

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.

EMR Group

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.

Phone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Passive suicidal ideation (NDDI-E item 4 score of 3 or 4)
• Age \<18 years

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Epilepsy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Heidi Munger Clary, MD, MPH
• Organization: Wake Forest School of Medicine

hmungerc@wakehealth.edu

336-716-7110

Study Officials

• Heidi M. Munger Clary, MD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: December 16, 2019
• Primary Completion: November 10, 2020
• Study Completion: September 27, 2021
• Last Updated: January 18, 2022
• Results First Posted: January 18, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)