Clinical Decision Support for Patient Migraine Management

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03706794

Acronym

CDST

Enrollment

Registered

2018-10-16

Start date

2019-06-05

Completion date

2022-03-13

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief 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. 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.

Interventions

BEHAVIORALClinical Decision Support Tool

Tailored education provided via a smartphone application.

BEHAVIORALHeadache Education

Non-tailored education provided via a smartphone application.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants will be informed that they will receive one of two educational interventions. The care provider is a smartphone application; the only person aware of the condition is the research assistant assigning participants to the smartphone application conditions. The investigator, research coordinator, and all other personnel including outcomes assessors will be unaware of condition.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Adherence to Acute Migraine Management Strategies: Treat Early	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	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	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	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.

Secondary

Measure	Time frame	Description
Headache Days	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.
Pain Interference	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.
Headache Pain Intensity	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.
Migraine-Related Disability	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.
Migraine-Specific Quality of Life	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Clinical Decision Support Tool Tailored education provided via a smartphone application Clinical Decision Support Tool: Tailored education provided via a smartphone application.	8
Headache Education Non-tailored education provided via a smartphone application. Headache Education: Non-tailored education provided via a smartphone application.	10
Total	18

Baseline characteristics

Characteristic	Clinical Decision Support Tool	Total	Headache Education
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	8 Participants	18 Participants	10 Participants
Age, Continuous	29.1 years STANDARD_DEVIATION 6.3	33.0 years STANDARD_DEVIATION 9	36.1 years STANDARD_DEVIATION 9.8
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	4 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants	14 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Headache Days	5.8 days/month STANDARD_DEVIATION 2.9	5.0 days/month STANDARD_DEVIATION 2.4	4.3 days/month STANDARD_DEVIATION 1.9
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Black or African American	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	6 Participants	14 Participants	8 Participants
Region of Enrollment United States	8 participants	18 participants	10 participants
Sex: Female, Male Female	7 Participants	15 Participants	8 Participants
Sex: Female, Male Male	1 Participants	3 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 10
other Total, other adverse events	0 / 8	1 / 10
serious Total, serious adverse events	0 / 8	0 / 10

Outcome results

Primary

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.