Trial Outcomes & Findings for Clinical Decision Support for Patient Migraine Management (NCT NCT03706794)

NCT ID: NCT03706794

Last Updated: 2025-04-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Month 6 of the Treatment
• Results posted on: 2025-04-06

Participant Flow

Participant milestones

Measure	Clinical Decision Support Tool Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Overall Study STARTED	8	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Decision Support for Patient Migraine Management

Baseline characteristics by cohort

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.1 years STANDARD_DEVIATION 6.3 • n=5 Participants	36.1 years STANDARD_DEVIATION 9.8 • n=7 Participants	33.0 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	9 Participants n=7 Participants	14 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants
Headache Days	5.8 days/month STANDARD_DEVIATION 2.9 • n=5 Participants	4.3 days/month STANDARD_DEVIATION 1.9 • n=7 Participants	5.0 days/month STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Adherence to Acute Migraine Management Strategies: Treat Early	0 Participants	2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Adherence to Acute Migraine Management Strategies: Overuse	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Adherence to Preventive Behavioral Strategies	10.1 days/month Standard Deviation 8.5	0.0 days/month Standard Deviation 0.0

PRIMARY outcome

Timeframe: Month 6 of the Treatment

Population: 4 participants in the 'Clinical Decision Support Tool (CDST)' arm and 3 participants in the 'Headache Education' arm had been taking a preventive medication and were able to be assessed for this Outcome Measure.

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.

Outcome measures

Measure	Clinical Decision Support Tool n=4 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=3 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Adherence to Preventive Medication	15.0 days/month Standard Deviation 7.5	12.3 days/month Standard Deviation 13.1

SECONDARY outcome

Timeframe: Month 6 of the Treatment

Participants recorded headaches in their electronic daily headache diary. The median number of headache days/month during Month 6 was summarized and reported.

Outcome measures

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Headache Days	3.4 days/month Interval 1.9 to 3.8	4.4 days/month Interval 2.1 to 5.3

SECONDARY outcome

Timeframe: Month 6 of the Treatment

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.

Outcome measures

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Headache Pain Intensity	5.0 score on a scale Interval 4.3 to 9.3	6.0 score on a scale Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: Month 6 of the Treatment

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.

Outcome measures

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Migraine-Related Disability	18.0 score on a scale Interval 7.5 to 26.3	12.5 score on a scale Interval 8.3 to 27.5

SECONDARY outcome

Timeframe: Month 6 of the Treatment

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.

Outcome measures

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Migraine-Specific Quality of Life	26.4 score on a scale Interval 14.0 to 58.9	21.6 score on a scale Interval 8.9 to 53.8

SECONDARY outcome

Timeframe: Month 6 of the Treatment

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.

Outcome measures

Measure	Clinical Decision Support Tool n=8 Participants Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 Participants Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Pain Interference	52.8 T-score Interval 42.5 to 61.6	55.8 T-score Interval 47.6 to 56.0

Adverse Events

Clinical Decision Support Tool

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Headache Education

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Clinical Decision Support Tool n=8 participants at risk Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	Headache Education n=10 participants at risk Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.
Infections and infestations COVID-19 Infection	0.00% 0/8 • Participants were contacted bi-weekly by the research coordinator and monthly by the research assistant throughout the study to assess for adverse events. The PI also monitored each participant's recorded headache diaries monthly to assess for adverse events. Adverse events were monitored/collected over a period of 3 months during the interventional phase of the study. Adverse Events were assessed in accordance with HHS/NIH/NCI Common Terminology Criteria for Adverse Events (Version 4.0)	10.0% 1/10 • Number of events 1 • Participants were contacted bi-weekly by the research coordinator and monthly by the research assistant throughout the study to assess for adverse events. The PI also monitored each participant's recorded headache diaries monthly to assess for adverse events. Adverse events were monitored/collected over a period of 3 months during the interventional phase of the study. Adverse Events were assessed in accordance with HHS/NIH/NCI Common Terminology Criteria for Adverse Events (Version 4.0)

Additional Information

Dr. Elizabeth Seng

Albert Einstein College of Medicine

Phone: 646-592-4368

Email: Elizabeth.Seng@einsteinmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place