Trial Outcomes & Findings for EMR Outcomes: Anxiety and Depression in Epilepsy (NCT NCT03879525)
NCT ID: NCT03879525
Last Updated: 2022-01-18
Results Overview
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2022-01-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EMR Outcomes: Anxiety and Depression in Epilepsy
Baseline characteristics by cohort
| Measure |
EMR Group
n=15 Participants
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.
|
Phone Group
n=15 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome pertains only to EMR group; phone group is analyzed in separate outcome.
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments in the EMR
Outcome measures
| Measure |
EMR Group
n=15 Participants
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.
|
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.
|
|---|---|---|
|
Percentage of Participants Retained in the Study in the EMR Arm
|
67 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome pertains only to the phone group; EMR group was analyzed in a different outcome.
Retention is defined as the percentage of participants in the study who complete the 6 month outcome instruments via phone
Outcome measures
| Measure |
EMR Group
n=15 Participants
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.
|
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.
|
|---|---|---|
|
Percentage of Participants Retained in the Study in the Phone Arm
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: BaselineQOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy. Total Score 0-100. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
EMR Group
n=15 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Quality of Life in Epilepsy-10 (QOLIE-10)
|
53.3 score on a scale
Standard Deviation 16.6
|
60.5 score on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 5 individuals in EMR arm did not return the 3 month outcome assessment
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.
Outcome measures
| Measure |
EMR Group
n=10 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Quality of Life in Epilepsy-10 (QOLIE-10)
|
61.0 score on a scale
Standard Deviation 18.6
|
57.3 score on a scale
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: 6 MonthsQOLIE-10 is A brief questionnaire (10-items) to screen for quality of life in epilepsy. Total Score 0-100. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
EMR Group
n=15 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Quality of Life in Epilepsy-10 (QOLIE-10)
|
57.6 score on a scale
Standard Deviation 20.3
|
62.6 score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: BaselineAnxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
EMR Group
n=15 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Generalized Anxiety Disorder 7-item (GAD-7) Scale
|
10.5 score on a scale
Standard Deviation 5.3
|
10.5 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 5 individuals in EMR arm did not return the 3 month outcome assessment
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
EMR Group
n=10 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Generalized Anxiety Disorder 7-item (GAD-7) Scale
|
6.0 score on a scale
Standard Deviation 3.0
|
10.2 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 6 monthsAnxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Outcome measures
| Measure |
EMR Group
n=15 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Generalized Anxiety Disorder 7-item (GAD-7) Scale
|
7.7 score on a scale
Standard Deviation 5.4
|
8.5 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
EMR Group
n=15 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Neurological Disorders Depression Inventory (NDDI-E)
|
15.4 score on a scale
Standard Deviation 2.8
|
15.3 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 5 individuals in EMR arm did not return the 3 month outcome assessment
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.
Outcome measures
| Measure |
EMR Group
n=10 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Neurological Disorders Depression Inventory (NDDI-E)
|
15.4 score on a scale
Standard Deviation 3.1
|
15.0 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 6 MonthsThe 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.
Outcome measures
| Measure |
EMR Group
n=15 Participants
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.
|
Phone Group
n=15 Participants
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.
|
|---|---|---|
|
Neurological Disorders Depression Inventory (NDDI-E)
|
14.7 score on a scale
Standard Deviation 3.9
|
13.8 score on a scale
Standard Deviation 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 MonthsOptional 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.
Outcome measures
Outcome data not reported
Adverse Events
EMR Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Phone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EMR Group
n=15 participants at risk
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.
|
Phone Group
n=15 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
status epilepticus
|
13.3%
2/15 • Number of events 2 • Baseline through 6 month follow up
|
0.00%
0/15 • Baseline through 6 month follow up
|
Other adverse events
Adverse event data not reported
Additional Information
Heidi Munger Clary, MD, MPH
Wake Forest School of Medicine
Phone: 336-716-7110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place