Quality of LifeNCT03879525
EMR Outcomes: Anxiety and Depression in Epilepsy
A study testing EMR-based-interventional method and Telephone-based-standard method in people with Quality of Life and Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Anxiety, Depression
- What is being tested?
- EMR-based-interventional method and Telephone-based-standard method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Passive suicidal ideation (NDDI-E item 4 score of 3 or 4)
- Age <18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)
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.
Read the 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.
- Conditions
- Quality of Life, Anxiety, Depression, Epilepsy
- Being tested
- EMR-based-interventional method, Telephone-based-standard method
- Keywords
- Electronic medical record, EMR, Patient Outcomes
- Medical subject headings
- Anxiety Disorders, Depression, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMR-based-interventional methodOther
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 methodOther
Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method.
| Study group | Role | What they receive |
|---|---|---|
| EMR Group | Experimental | Participants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. Receives: 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. Receives: Other: Telephone-based-standard method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (10)
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
Measured: 6 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Measured: Baseline
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Measured: 3 Months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Anxiety scale. Total Score 0-28. Higher scores denotes worse outcomes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start16 Dec 2019
- Primary completion10 Nov 2020
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi M. Munger Clary, MD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879525
- Sponsor's protocol ID
- IRB00056740
- Status last verified
- Sep 2021
- First submitted
- 15 Mar 2019
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will consider requests if received.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Depression in Epilepsy: Assessing Outcomes Using the Electronic Medical Record (EMR)
- ClinicalTrials.gov ID
- NCT03879525
- Acronym / sponsor ID
- IRB00056740
- Conditions
- Quality of Life, Anxiety, Depression, Epilepsy
- Keywords
- Electronic medical record, EMR, Patient Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMR Group | Experimental | Other: EMR-based-interventional methodParticipants assigned to this arm will complete the questionnaires in the EMR using the EMR-based-interventional method. |
| Phone Group | Active comparator | Other: Telephone-based-standard methodParticipants assigned to this arm will complete the questionnaires via the Phone using the Telephone-based-standard method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Passive suicidal ideation (NDDI-E item 4 score of 3 or 4)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMR-based-interventional methodQuestionnaire 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. | Other | EMR Group |
| Telephone-based-standard methodQuestionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standard delivery method. | Other | Phone Group |
Primary outcome
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
10 secondary outcomes
Percentage of Participants Retained in the Study in the Phone Arm
Time frame: 6 months
Quality of Life in Epilepsy-10 (QOLIE-10)
Time frame: Baseline
Quality of Life in Epilepsy-10 (QOLIE-10)
Time frame: 3 Months
Quality of Life in Epilepsy-10 (QOLIE-10)
Time frame: 6 Months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time frame: Baseline
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time frame: 3 Months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time frame: 6 months
Neurological Disorders Depression Inventory (NDDI-E)
Time frame: Baseline
Neurological Disorders Depression Inventory (NDDI-E)
Time frame: 3 Months
Neurological Disorders Depression Inventory (NDDI-E)
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Will consider requests if received.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi M. Munger Clary, MD, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMR-based-interventional method and Telephone-based-standard method in people with Quality of Life and Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Retained in the Study in the EMR Arm (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.