Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Decision Support for Patient Migraine Management (CDST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE October 16, 2018
Last Update Posted Date April 16, 2019
Estimated Study Start Date  ICMJE April 11, 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • 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.
  • 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.
  • Adherence to Preventive Behavioral Strategies [ Time Frame: Month 6 of the Treatment ]
    Number of adherent days/month
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • Adherence to Acute Migraine Management Strategies: Treat Early [ Time Frame: Six months of the study ]
    Number of treat early with MSM days/Number of headache days
  • Adherence to Acute Migraine Management Strategies: Avoid Overuse [ Time Frame: Six months of the study ]
    Number of MSM days/month
  • Adherence to Preventive Behavioral Strategies [ Time Frame: Six months of the study ]
    Number of adherent days/month
Change History Complete list of historical versions of study NCT03706794 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • Adherence to preventive medication [ Time Frame: Month 6 of the Treatment ]
    Number of adherent days/month
  • Headache days [ Time Frame: Month 6 of the Treatment ]
    Number of headache days/month
  • Average head pain [ Time Frame: Month 6 of the Treatment ]
    Average of daily head pain assessments/month
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • Adherence to preventive medication [ Time Frame: Six months of the study ]
    Number of adherent days/month
  • Headache days [ Time Frame: Six months of the study ]
    Number of headache days/month
  • Average head pain [ Time Frame: Six months of the study ]
    Average of daily head pain assessments/month
  • Migraine-Related Disability [ Time Frame: Six months of the study ]
    Migraine Disability Assessment (MIDAS)
  • Migraine-Specific Quality of Life [ Time Frame: Six months of the study ]
    Migraine-Specific Quality of Life Questionnaire ( v2.1)
  • Pain Interference [ Time Frame: Six months of the study ]
    PROMIS-Pain Interference
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Decision Support for Patient Migraine Management
Official Title  ICMJE Clinical Decision Support for Patient Migraine Management
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Migraine
Intervention  ICMJE
  • Behavioral: Clinical Decision Support Tool
    Tailored education provided via a smartphone application.
  • Behavioral: Headache Education
    Non-tailored education provided via a smartphone application.
Study Arms  ICMJE
  • Experimental: Clinical Decision Support Tool
    Tailored education provided via a smartphone application
    Intervention: Behavioral: Clinical Decision Support Tool
  • Active Comparator: Headache Education
    Non-tailored education provided via a smartphone application.
    Intervention: Behavioral: Headache Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Seng, Ph.D. 646-592-4368 eseng@montefiore.org
Contact: Barbara Ladenheim, Ph.D. barmende@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03706794
Other Study ID Numbers  ICMJE 2015-5743
1K23NS096107-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elizabeth Seng, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Elizabeth Seng, PhD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP