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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMR Group | Experimental | Participants assigned to this arm will complete the questionnaires in the EMR using the 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Quality of Life in Epilepsy-10 (QOLIE-10) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi M. Munger Clary, MD, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
Will consider requests if received.
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| ID | Title | Description |
|---|---|---|
| FG000 | EMR Group | Participants assigned to this arm will complete the questionnaires in the Electronic Medical Record (EMR) using the EMR-based-interventional method. 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. |
| FG001 | Phone Group | Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EMR Group | Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | This outcome pertains only to EMR group; phone group is analyzed in separate outcome. | Posted | Number | percentage of participants | 6 months |
|
Baseline through 6 month follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMR Group | Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| status epilepticus | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heidi Munger Clary, MD, MPH | Wake Forest School of Medicine | 336-716-7110 | hmungerc@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2020 | Jun 9, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2020 | Dec 22, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
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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.
| 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. |
|
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 |
| 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 |
| 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 |
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | Baseline |
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | 3 Months |
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | 6 months |
| 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 |
| 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 |
| 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 |
| BG001 | Phone Group | Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | This outcome pertains only to the phone group; EMR group was analyzed in a different outcome. | Posted | Number | percentage of participants | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 5 individuals in EMR arm did not return the 3 month outcome assessment | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
|
|
| Secondary | Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | 5 individuals in EMR arm did not return the 3 month outcome assessment | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
|
|
|
| Secondary | Generalized Anxiety Disorder 7-item (GAD-7) Scale | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 5 individuals in EMR arm did not return the 3 month outcome assessment | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
|
|
| Other Pre-specified | 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. | Not Posted | 13 Months | Participants |
| 0 |
| 15 |
| 2 |
| 15 |
| 0 |
| 15 |
| EG001 | Phone Group | Participants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |