EpilepsyNCT02646631
Behavioral and Educational Tools to Improve Epilepsy Care
A study testing Management of Risks in Epilepsy (MORE), Telephone-based motivational interviewing (MORE+MI) and Educational Materials in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
Trial summary
The long-term goal of this research is to improve seizure control among patients with epilepsy, which has the potential to improve quality of life for thousands of people living with epilepsy and reduce health care utilization, social and economic costs, and epilepsy-related mortalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Management of Risks in Epilepsy (MORE), Telephone-based motivational interviewing (MORE+MI) and Educational Materials
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 20 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least 18 years of age
- English- or Spanish-speaking
- Partial (focal) or generalized epilepsy (as confirmed with epileptiform activity on an electroencephalogram)
- Poor medication adherence
- Willing and able to use a smartphone (provided by the study) to manage disease.
Who cannot join
- Known or suspected psychogenic nonepileptic seizures as sole seizure type
- Active psychotic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The long-term goal of this research is to improve seizure control among patients with epilepsy, which has the potential to improve quality of life for thousands of people living with epilepsy and reduce health care utilization, social and economic costs, and epilepsy-related mortalities. Participants who are suffering from epilepsy will be randomized to receive usual care (UC), a smartphone-based self-management intervention called Management of Risks in Epilepsy (MORE), or MORE + telephone-based motivational interviewing (MI). Participants will be followed for 3 months.
- Conditions
- Epilepsy
- Being tested
- Usual Care, Management of Risks in Epilepsy (MORE), Telephone-based motivational interviewing (MORE+MI), Educational Materials
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Participants assigned to this treatment will receive the usual care as determined by their physician
Management of Risks in Epilepsy (MORE)Behavioural
MORE is a smartphone application which participants use to record information on a daily basis about seizures (severity, type), medications, and mood and stress levels. It also includes a camera-based application which uses a pill scanner and photo to record the identity and quantity (dose) of medications just prior to them being taken. Also included in the app are medication reminders, educational video clips, and self-management tips.
Telephone-based motivational interviewing (MORE+MI)Behavioural
Participants will receive a total of 4 motivational interviewing sessions over the phone. These sessions last approximately 20 minutes each and build on the educational materials already provided within the MORE app.
Educational MaterialsOther
Printed educational materials on the management of epilepsy
| Study group | Role | What they receive |
|---|---|---|
| Usual Treatment | Experimental | Not described Receives: Other: Usual Care; Other: Educational Materials |
| MORE | Experimental | Not described Receives: Other: Usual Care; Behavioral: Management of Risks in Epilepsy (MORE); Other: Educational Materials |
| MORE + MI | Active comparator | Not described Receives: Other: Usual Care; Behavioral: Management of Risks in Epilepsy (MORE); Behavioral: Telephone-based motivational interviewing (MORE+MI); Other: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent adherence to anti-epileptic drug schedule (pill counts)
Measured: 3 months
Secondary outcomes (7)
Number of patients who complete the study
Measured: 3 months
Percentage of MI sessions completed
Measured: 3 months
Percentage of diary entries completed
Measured: 3 months
Adherence to anti-epileptic drug schedule (self-reported) as measured by the Morisky Medication Adherence Scale
As measured by the Morisky Medication Adherence Scale
Measured: 3 months
Seizure frequency
Measured: 3 months
Quality of life as measured by the Quality of Life in Epilepsy questionnaire score
Measured: 3 months
Quality of life as measured by the PROMIS-10 questionnaire score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startSep 2016
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Tanya Spruill, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646631
- Sponsor's protocol ID
- 15-01386
- Status last verified
- Dec 2018
- First submitted
- 4 Jan 2016
- Last updated
- 24 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Educational Tools to Improve Epilepsy Care
- ClinicalTrials.gov ID
- NCT02646631
- Acronym / sponsor ID
- 15-01386
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Sep 2016
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal of this research is to improve seizure control among patients with epilepsy, which has the potential to improve quality of life for thousands of people living with epilepsy and reduce health care utilization, social and economic costs, and epilepsy-related mortalities. Participants who are suffering from epilepsy will be randomized to receive usual care (UC), a smartphone-based self-management intervention called Management of Risks in Epilepsy (MORE), or MORE + telephone-based motivational interviewing (MI). Participants will be followed for 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Treatment | Experimental | Other: Usual Care, Other: Educational Materials |
| MORE | Experimental | Other: Usual Care, Behavioral: Management of Risks in Epilepsy (MORE), Other: Educational Materials |
| MORE + MI | Active comparator | Other: Usual Care, Behavioral: Management of Risks in Epilepsy (MORE), Behavioral: Telephone-based motivational interviewing (MORE+MI), Other: Educational Materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- English- or Spanish-speaking
- Partial (focal) or generalized epilepsy (as confirmed with epileptiform activity on an electroencephalogram)
- Poor medication adherence
- Willing and able to use a smartphone (provided by the study) to manage disease.
Key exclusion criteria (2 listed)
- Known or suspected psychogenic nonepileptic seizures as sole seizure type
- Active psychotic disorder
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 |
|---|---|---|
| Usual CareParticipants assigned to this treatment will receive the usual care as determined by their physician | Other | MORE, MORE + MI, Usual Treatment |
| Management of Risks in Epilepsy (MORE)MORE is a smartphone application which participants use to record information on a daily basis about seizures (severity, type), medications, and mood and stress levels. It also includes a camera-based application which uses a pill scanner and photo to record the identity and quantity (dose) of medications just prior to them being taken. Also included in the app are medication reminders, educational video clips, and self-management tips. | Behavioural | MORE, MORE + MI |
| Telephone-based motivational interviewing (MORE+MI)Participants will receive a total of 4 motivational interviewing sessions over the phone. These sessions last approximately 20 minutes each and build on the educational materials already provided within the MORE app. | Behavioural | MORE + MI |
| Educational MaterialsPrinted educational materials on the management of epilepsy | Other | MORE, MORE + MI, Usual Treatment |
Primary outcome
Percent adherence to anti-epileptic drug schedule (pill counts)
Time frame: 3 months
7 secondary outcomes
Number of patients who complete the study
Time frame: 3 months
Percentage of MI sessions completed
Time frame: 3 months
Percentage of diary entries completed
Time frame: 3 months
Adherence to anti-epileptic drug schedule (self-reported) as measured by the Morisky Medication Adherence Scale
Time frame: 3 months
Seizure frequency
Time frame: 3 months
Quality of life as measured by the Quality of Life in Epilepsy questionnaire score
Time frame: 3 months
Quality of life as measured by the PROMIS-10 questionnaire score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
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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.
Tanya Spruill principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management of Risks in Epilepsy (MORE), Telephone-based motivational interviewing (MORE+MI) and Educational Materials in people with Epilepsy, run by NYU Langone Health 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 5 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 24 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent adherence to anti-epileptic drug schedule (pill counts) (time frame: 3 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 24 Dec 2018.