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Clinical Decision Support for Patient Migraine Management (CDST)

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ClinicalTrials.gov Identifier: NCT03706794
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Elizabeth Seng, Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Migraine Behavioral: Clinical Decision Support Tool Behavioral: Headache Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Primary Purpose: Treatment
Official Title: Clinical Decision Support for Patient Migraine Management
Estimated Study Start Date : April 11, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Clinical Decision Support Tool
Tailored education provided via a smartphone application
Behavioral: Clinical Decision Support Tool
Tailored education provided via a smartphone application.

Active Comparator: Headache Education
Non-tailored education provided via a smartphone application.
Behavioral: Headache Education
Non-tailored education provided via a smartphone application.




Primary Outcome Measures :
  1. Adherence to Acute Migraine Management Strategies: Treat Early [ Time Frame: Month 6 of the Treatment ]
    When participants record headache activity they are asked about the type of headache and the level of pain they were experiencing when they took their Migraine Specific Medication (MSM). A headache episode is coded as "Treat Early" if a participant took their MSM when the pain is mild (as opposed to moderate or severe). Number of Treat Early is reported.

  2. Adherence to Acute Migraine Management Strategies: Overuse [ Time Frame: Month 6 of the Treatment ]
    Number of days per month that Migraine Specific Medication is used is taken directly from diary recordings. Overuse is considered taking MSM more than 10 times in a month. Total overuse is reported.

  3. Adherence to Preventive Behavioral Strategies [ Time Frame: Month 6 of the Treatment ]
    Number of adherent days/month


Secondary Outcome Measures :
  1. Adherence to preventive medication [ Time Frame: Month 6 of the Treatment ]
    Number of adherent days/month

  2. Headache days [ Time Frame: Month 6 of the Treatment ]
    Number of headache days/month

  3. Average head pain [ Time Frame: Month 6 of the Treatment ]
    Average of daily head pain assessments/month

  4. Migraine-Related Disability [ Time Frame: Month 6 of the Treatment ]
    Migraine Disability Assessment (MIDAS) measures migraine-related functional impairment. Total score ranges from 0 - 270, higher scores indicate higher degrees of impairment. Scores of 21 and above are considered "severe" levels of migraine-related disability.

  5. Migraine-Specific Quality of Life [ Time Frame: Month 6 of the Treatment ]
    Migraine-Specific Quality of Life Questionnaire ( v2.1), measures migraine-related quality of life. Total score ranges from 14-84, higher scores indicate lower migraine-related quality of life.

  6. Pain Interference [ Time Frame: Month 6 of the Treatment ]
    PROMIS (Patient-Reported Outcomes Measurement Information System) - Pain Interference measures the self-reported consequences of pain on relevant aspects of one's life. Total score ranges from 6 - 30, higher scores indicate more interference with activities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706794


Contacts
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Contact: Elizabeth Seng, Ph.D. 646-592-4368 eseng@montefiore.org
Contact: Barbara Ladenheim, Ph.D. barmende@montefiore.org

Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Elizabeth Seng, PhD    718-430-1855    Elizabeth.Seng@einstein.yu.edu   
Contact: Barbara Ladenheim, PhD       barmende@montefiore.org   
Principal Investigator: Elizabeth Seng, PhD         
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Elizabeth Seng, PhD Albert Einstein College of Medicine

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Responsible Party: Elizabeth Seng, Research Assistant Professor of Neurology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03706794     History of Changes
Other Study ID Numbers: 2015-5743
1K23NS096107-01 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases