Clinical Decision Support for Patient Migraine Management (CDST)
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support Tool
Headache Education
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility 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.
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clinical Decision Support Tool
Headache Education
Arm Description
Tailored education provided via a smartphone application
Non-tailored education provided via a smartphone application.
Outcomes
Primary Outcome Measures
Adherence to Acute Migraine Management Strategies: Treat Early
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.
Adherence to Acute Migraine Management Strategies: Overuse
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.
Adherence to Preventive Behavioral Strategies
Number of adherent days/month
Secondary Outcome Measures
Adherence to preventive medication
Number of adherent days/month
Headache days
Number of headache days/month
Average head pain
Average of daily head pain assessments/month
Migraine-Related Disability
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.
Migraine-Specific Quality of Life
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.
Pain Interference
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.
Full Information
NCT ID
NCT03706794
First Posted
October 4, 2018
Last Updated
September 1, 2022
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT03706794
Brief Title
Clinical Decision Support for Patient Migraine Management
Acronym
CDST
Official Title
Clinical Decision Support for Patient Migraine Management
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
March 13, 2022 (Actual)
Study Completion Date
March 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Decision Support Tool
Arm Type
Experimental
Arm Description
Tailored education provided via a smartphone application
Arm Title
Headache Education
Arm Type
Active Comparator
Arm Description
Non-tailored education provided via a smartphone application.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Decision Support Tool
Intervention Description
Tailored education provided via a smartphone application.
Intervention Type
Behavioral
Intervention Name(s)
Headache Education
Intervention Description
Non-tailored education provided via a smartphone application.
Primary Outcome Measure Information:
Title
Adherence to Acute Migraine Management Strategies: Treat Early
Description
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.
Time Frame
Month 6 of the Treatment
Title
Adherence to Acute Migraine Management Strategies: Overuse
Description
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.
Time Frame
Month 6 of the Treatment
Title
Adherence to Preventive Behavioral Strategies
Description
Number of adherent days/month
Time Frame
Month 6 of the Treatment
Secondary Outcome Measure Information:
Title
Adherence to preventive medication
Description
Number of adherent days/month
Time Frame
Month 6 of the Treatment
Title
Headache days
Description
Number of headache days/month
Time Frame
Month 6 of the Treatment
Title
Average head pain
Description
Average of daily head pain assessments/month
Time Frame
Month 6 of the Treatment
Title
Migraine-Related Disability
Description
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.
Time Frame
Month 6 of the Treatment
Title
Migraine-Specific Quality of Life
Description
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.
Time Frame
Month 6 of the Treatment
Title
Pain Interference
Description
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.
Time Frame
Month 6 of the Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Seng, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Decision Support for Patient Migraine Management
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