Anxiety, Depression, Epilepsy, Quality of Life
Conditions
Keywords
Electronic medical record, EMR, Patient Outcomes
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.
Interventions
OTHEREMR-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.
OTHERTelephone-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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Retained in the Study in the EMR Arm | 6 months | Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Retained in the Study in the Phone Arm | 6 months | 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) | 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. |
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | Baseline | Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes. |
| Neurological Disorders Depression Inventory (NDDI-E) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Semi-Structured Interviews | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | EMR Group | Total | Phone Group |
|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 13.4 | 42.5 years STANDARD_DEVIATION 12.8 | 42.5 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 30 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 23 Participants | 12 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 7 Participants | 18 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 2 / 15 | 0 / 15 |
Outcome results
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
Time frame: 6 months
Population: This outcome pertains only to EMR group; phone group is analyzed in separate outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMR Group | Percentage of Participants Retained in the Study in the EMR Arm | 67 percentage of participants |
Secondary
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time frame: 3 Months
Population: 5 individuals in EMR arm did not return the 3 month outcome assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 6.0 score on a scale | Standard Deviation 3 |
| Phone Group | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 10.2 score on a scale | Standard Deviation 4.2 |
Secondary
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 10.5 score on a scale | Standard Deviation 5.3 |
| Phone Group | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 10.5 score on a scale | Standard Deviation 3.8 |
Secondary
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 7.7 score on a scale | Standard Deviation 5.4 |
| Phone Group | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 8.5 score on a scale | Standard Deviation 5 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Neurological Disorders Depression Inventory (NDDI-E) | 15.4 score on a scale | Standard Deviation 2.8 |
| Phone Group | Neurological Disorders Depression Inventory (NDDI-E) | 15.3 score on a scale | Standard Deviation 3.4 |
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Neurological Disorders Depression Inventory (NDDI-E) | 14.7 score on a scale | Standard Deviation 3.9 |
| Phone Group | Neurological Disorders Depression Inventory (NDDI-E) | 13.8 score on a scale | Standard Deviation 3.4 |
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.
Time frame: 3 Months
Population: 5 individuals in EMR arm did not return the 3 month outcome assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Neurological Disorders Depression Inventory (NDDI-E) | 15.4 score on a scale | Standard Deviation 3.1 |
| Phone Group | Neurological Disorders Depression Inventory (NDDI-E) | 15.0 score on a scale | Standard Deviation 2.6 |
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
Time frame: 6 months
Population: This outcome pertains only to the phone group; EMR group was analyzed in a different outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMR Group | Percentage of Participants Retained in the Study in the Phone Arm | 100 percentage of participants |
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.
Time frame: 3 Months
Population: 5 individuals in EMR arm did not return the 3 month outcome assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Quality of Life in Epilepsy-10 (QOLIE-10) | 61.0 score on a scale | Standard Deviation 18.6 |
| Phone Group | Quality of Life in Epilepsy-10 (QOLIE-10) | 57.3 score on a scale | Standard Deviation 15.7 |
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Quality of Life in Epilepsy-10 (QOLIE-10) | 57.6 score on a scale | Standard Deviation 20.3 |
| Phone Group | Quality of Life in Epilepsy-10 (QOLIE-10) | 62.6 score on a scale | Standard Deviation 16.7 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EMR Group | Quality of Life in Epilepsy-10 (QOLIE-10) | 53.3 score on a scale | Standard Deviation 16.6 |
| Phone Group | Quality of Life in Epilepsy-10 (QOLIE-10) | 60.5 score on a scale | Standard Deviation 18.6 |
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.
Time frame: 13 Months