MigraineCDSTNCT03706794
Clinical Decision Support for Patient Migraine Management
A study testing Clinical Decision Support Tool and Headache Education in people with Migraine, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
Little is known about who adheres to migraine management strategies, and circumstances that enhance adherence. This knowledge is required to develop patient-level interventions to improve adherence to migraine management strategies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Clinical Decision Support Tool and Headache Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 13 Mar 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have an International Classification of Headache Disorders - 3 beta diagnosis of migraine
- Self-report and diary-confirmed 6 to 14 headache days per month
- Are currently prescribed a triptan for acute migraine management
- Are stable on current preventive and acute treatment regimen for migraine
- Are between the ages of 18 and 65
- Reads and understands English
- Has capacity to consent
- Completes 80% of diary recordings in the first 30 days of monitoring
Who cannot join
- Probable or confirmed medication overuse headache
- A plan to change, or changing preventive or acute migraine medication during study participation
- Are pregnant or are planning to become pregnant during study involvement (as triptans are Category C medications)
- Psychiatric illness or cognitive difficulties that would interfere with participation in the study
- Participated in the pilot development of the intervention evaluated by this research protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Little is known about who adheres to migraine management strategies, and circumstances that enhance adherence. This knowledge is required to develop patient-level interventions to improve adherence to migraine management strategies. The proposed project will pilot the first patient level intervention designed to improve adherence to preventive and acute migraine management strategies. The study will identify people most at risk for non-adherence to migraine management strategies. Participants will be randomly assigned to receive a tailored clinical decision support tool or education intervention.
Read the detailed description
Participants with a diagnosis with migraine who currently meet criteria for episodic migraine (migraine with headaches that occur on fewer than 15 days per month) will be recruited from local providers. After an initial screening, eligible participants will complete 30 days of monitoring 3 times daily on an electronic headache diary (a smartphone app) to confirm study eligibility. Participants whose eligibility is confirmed will complete an additional 2 months (60 days) of monitoring headache activity and adherence to acute and preventive (medication and behavioral) strategies recommended for people with migraine. Participants who show suboptimal adherence during the first 3 months of monitoring (<50% of eligible days) will be eligible to continue to the intervention component of the study. Participants who choose to continue in the study will be randomized to receive a tailored clinical decision support tool or education intervention, both delivered through the smartphone app. Participants will continue to self-monitor, with the intervention components active, for 3 months.
- Conditions
- Migraine
- Being tested
- Clinical Decision Support Tool, Headache Education
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support ToolBehavioural
Tailored education provided via a smartphone application.
Headache EducationBehavioural
Non-tailored education provided via a smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Support Tool | Experimental | Tailored education provided via a smartphone application Receives: Behavioral: Clinical Decision Support Tool |
| Headache Education | Active comparator | Non-tailored education provided via a smartphone application. Receives: Behavioral: Headache Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Acute Migraine Management Strategies: Treat Early
Participants record headache activity in an electronic daily headache diary and if experiencing a headache were asked about the type of headache and the level of pain experienced when they took the Migraine Specific Medication (MSM). A headache episode is coded as "Treat Early" if a participant took the MSM when the pain was mild (as opposed to moderate or severe). The number of participants who were "Treated early" during Month 6 is reported by study arm/group.
Measured: Month 6 of the Treatment
Adherence to Acute Migraine Management Strategies: Overuse
Overuse is considered taking Migraine Specific Medication (MSM) more than 10 times in a month or a Nonsteroidal Anti-Inflammatory drug (NSAID) (non-combination) 15 or more times per month. The number of participants who met the definition of overuse during Month 6 is summarized and reported by study arm/group.
Measured: Month 6 of the Treatment
Adherence to Preventive Behavioral Strategies
Adherence to Preventive Behavioral Strategies is determined by the mean number of documented adherent days/month for a single preventive behavioral strategy, either stress management, sleep management, or consistent eating. The behavioral strategy was selected by the investigator and determined as the strategy with which the participant had the poorest adherence during the baseline run in period. Preventive Behavioral Strategies were evaluated daily in the electronic headache diary. Adherence to one of the aforementioned Preventive Behavioral Strategies during Month 6 is reported.
Measured: Month 6 of the Treatment
Adherence to Preventive Medication
If a participant was taking a preventive medication, adherence to preventive medication was assessed as the number of days/month participants took their preventive medication as recorded in the electronic daily headache diary. Taking preventive medication = Adherent, Not taking preventive medication = Not-adherent. The mean number of "Adherent" days/month in Month 6 are reported.
Measured: Month 6 of the Treatment
Secondary outcomes (5)
Headache Days
Participants recorded headaches in their electronic daily headache diary. The median number of headache days/month during Month 6 was summarized and reported.
Measured: Month 6 of the Treatment
Headache Pain Intensity
Headache pain intensity was recorded in an electronic daily headache diary. If a headache was confirmed, the average one-month headache pain intensity was assessed on a 0-10 scale, where 0 indicated no pain and 10 indicated the worst pain imaginable. The median headache pain intensity during Month 6 was summarized and reported.
Measured: Month 6 of the Treatment
Migraine-Related Disability
Migraine Disability Assessment (MIDAS) is a 5-item questionnaire used to measure migraine-related functional impairment. The survey queries as to the number of lost days of housework, job-work, and non-work activities over the prior 90-day period. Each item is an open entry allowing for input of the number of days lost over the prior 90 days. Total score ranges from 0 - 270, with higher scores indicate higher degrees of impairment/disability. Scores of 21 and above are considered "severe" levels of migraine-related disability. Group median MIDAS scores collected at Month 6 were summarized and reported.
Measured: Month 6 of the Treatment
Migraine-Specific Quality of Life
The Migraine-Specific Quality of Life (MSQL) questionnaire (v2.1), a 14-item survey, was used to measure migraine-related quality of life. Responses on the MSQL assessed the effect on migraines on daily activity over the prior 4 weeks and were scored from 1 ("None of the Time") to 6 ("All of the Time"), for an overall total scoring range of 14-84. Higher scores indicated lower migraine-related quality of life. Group median MSQL scores at Month 6 were summarized and reported.
Measured: Month 6 of the Treatment
Pain Interference
Pain Interference was evaluated using v1.0 of the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference (PI) Short Form (PROMIS-PI). PROMIS-PI is an 8-item survey which evaluates the self-reported consequences of pain on aspects of daily life activities and enjoyment of life over the past 7 days. Possible response options ranged from 1 ("Not at all") to 5 ("Very Much"). Raw scores were converted to T-scores using population norms with a mean of 50 and a standard deviation of 15 such that a Pain Interference score of 65 would be one SD worse than average, such that a person has more problems with pain hindering activities, and a pain interference score of 35 is one SD better than the average.
Measured: Month 6 of the Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start5 Jun 2019
- Primary completion13 Mar 2022
- Study completion13 Mar 2022
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 MigraineStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Elizabeth Seng, Albert Einstein College of Medicine
- Investigators
- Elizabeth Seng, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706794
- Sponsor's protocol ID
- 2015-5743
- Other IDs
- 1K23NS096107-01
- Acronym
- CDST
- Status last verified
- Apr 2025
- First submitted
- 4 Oct 2018
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support for Patient Migraine Management
- ClinicalTrials.gov ID
- NCT03706794
- Acronym / sponsor ID
- CDST / 2015-5743
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 13 Mar 2022 (actual)
- Study completion
- 13 Mar 2022 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Posted 6 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Little is known about who adheres to migraine management strategies, and circumstances that enhance adherence. This knowledge is required to develop patient-level interventions to improve adherence to migraine management strategies. The proposed project will pilot the first patient level intervention designed to improve adherence to preventive and acute migraine management strategies. The study will identify people most at risk for non-adherence to migraine management strategies. Participants will be randomly assigned to receive a tailored clinical decision support tool or education intervention.
Detailed description
Participants with a diagnosis with migraine who currently meet criteria for episodic migraine (migraine with headaches that occur on fewer than 15 days per month) will be recruited from local providers. After an initial screening, eligible participants will complete 30 days of monitoring 3 times daily on an electronic headache diary (a smartphone app) to confirm study eligibility. Participants whose eligibility is confirmed will complete an additional 2 months (60 days) of monitoring headache activity and adherence to acute and preventive (medication and behavioral) strategies recommended for people with migraine. Participants who show suboptimal adherence during the first 3 months of monitoring (<50% of eligible days) will be eligible to continue to the intervention component of the study. Participants who choose to continue in the study will be randomized to receive a tailored clinical decision support tool or education intervention, both delivered through the smartphone app. Participants will continue to self-monitor, with the intervention components active, for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support Tool | Experimental | Behavioral: Clinical Decision Support ToolTailored education provided via a smartphone application |
| Headache Education | Active comparator | Behavioral: Headache EducationNon-tailored education provided via a smartphone application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have an International Classification of Headache Disorders - 3 beta diagnosis of migraine
- Self-report and diary-confirmed 6 to 14 headache days per month
- Are currently prescribed a triptan for acute migraine management
- Are stable on current preventive and acute treatment regimen for migraine
- Are between the ages of 18 and 65
Key exclusion criteria (5 listed)
- Probable or confirmed medication overuse headache
- A plan to change, or changing preventive or acute migraine medication during study participation
- Are pregnant or are planning to become pregnant during study involvement (as triptans are Category C medications)
- Psychiatric illness or cognitive difficulties that would interfere with participation in the study
- Participated in the pilot development of the intervention evaluated by this research protocol.
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 |
|---|---|---|
| Clinical Decision Support ToolTailored education provided via a smartphone application. | Behavioural | Clinical Decision Support Tool |
| Headache EducationNon-tailored education provided via a smartphone application. | Behavioural | Headache Education |
Primary outcome
Adherence to Acute Migraine Management Strategies: Treat Early
Time frame: Month 6 of the Treatment
Participants record headache activity in an electronic daily headache diary and if experiencing a headache were asked about the type of headache and the level of pain experienced when they took the Migraine Specific Medication (MSM). A headache episode is coded as "Treat Early" if a participant took the MSM when the pain was mild (as opposed to moderate or severe). The number of participants who were "Treated early" during Month 6 is reported by study arm/group.
Adherence to Acute Migraine Management Strategies: Overuse
Time frame: Month 6 of the Treatment
Overuse is considered taking Migraine Specific Medication (MSM) more than 10 times in a month or a Nonsteroidal Anti-Inflammatory drug (NSAID) (non-combination) 15 or more times per month. The number of participants who met the definition of overuse during Month 6 is summarized and reported by study arm/group.
Adherence to Preventive Behavioral Strategies
Time frame: Month 6 of the Treatment
Adherence to Preventive Behavioral Strategies is determined by the mean number of documented adherent days/month for a single preventive behavioral strategy, either stress management, sleep management, or consistent eating. The behavioral strategy was selected by the investigator and determined as the strategy with which the participant had the poorest adherence during the baseline run in period. Preventive Behavioral Strategies were evaluated daily in the electronic headache diary. Adherence to one of the aforementioned Preventive Behavioral Strategies during Month 6 is reported.
Adherence to Preventive Medication
Time frame: Month 6 of the Treatment
If a participant was taking a preventive medication, adherence to preventive medication was assessed as the number of days/month participants took their preventive medication as recorded in the electronic daily headache diary. Taking preventive medication = Adherent, Not taking preventive medication = Not-adherent. The mean number of "Adherent" days/month in Month 6 are reported.
5 secondary outcomes
Headache Days
Time frame: Month 6 of the Treatment
Headache Pain Intensity
Time frame: Month 6 of the Treatment
Migraine-Related Disability
Time frame: Month 6 of the Treatment
Migraine-Specific Quality of Life
Time frame: Month 6 of the Treatment
Pain Interference
Time frame: Month 6 of the Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Elizabeth Seng, PhD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support Tool and Headache Education in people with Migraine, run by Albert Einstein College of Medicine 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 8 inclusion and 5 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 6 Apr 2025. 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 6 Apr 2025). 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?
Adherence to Acute Migraine Management Strategies: Treat Early (time frame: Month 6 of the Treatment). The study lists 4 primary outcomes in all. 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 6 Apr 2025.