Clinical Decision Support for Patient Migraine Management

NCT03706794 | Completed Results DMC

• 2 other identifiers: 2015-57431K23NS096107-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Month 6 of the Treatment

Secondary Outcomes (5)

• Headache Days

  Month 6 of the Treatment

• Headache Pain Intensity

  Month 6 of the Treatment

• Migraine-Related Disability

  Month 6 of the Treatment

• Migraine-Specific Quality of Life

  Month 6 of the Treatment

• Pain Interference

  Month 6 of the Treatment

Study Arms (2)

Clinical Decision Support Tool

EXPERIMENTAL

Tailored education provided via a smartphone application

Behavioral: Clinical Decision Support Tool

Headache Education

ACTIVE COMPARATOR

Non-tailored education provided via a smartphone application.

Behavioral: Headache Education

Interventions

Clinical Decision Support Tool BEHAVIORAL

Tailored education provided via a smartphone application.

Clinical Decision Support Tool

Headache Education BEHAVIORAL

Non-tailored education provided via a smartphone application.

Headache Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Elizabeth Seng
• Organization: Albert Einstein College of Medicine

Elizabeth.Seng@einsteinmed.edu

646-592-4368

Study Officials

• Elizabeth Seng, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Neurology

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 16, 2018
• Study Start: June 5, 2019
• Primary Completion: March 13, 2022
• Study Completion: March 13, 2022
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)