Clinical Decision Support for Patient Migraine Management

NCT ID: NCT03706794

Last Updated: 2025-04-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2022-03-13

Brief Summary

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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

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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

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Clinical Decision Support Tool

Tailored education provided via a smartphone application

Group Type EXPERIMENTAL

Clinical Decision Support Tool

Intervention Type BEHAVIORAL

Tailored education provided via a smartphone application.

Headache Education

Non-tailored education provided via a smartphone application.

Group Type ACTIVE_COMPARATOR

Headache Education

Intervention Type BEHAVIORAL

Non-tailored education provided via a smartphone application.

Interventions

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Clinical Decision Support Tool

Tailored education provided via a smartphone application.

Intervention Type BEHAVIORAL

Headache Education

Non-tailored education provided via a smartphone application.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Seng

Research Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Seng, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1K23NS096107-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-5743

Identifier Type: -

Identifier Source: org_study_id

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