Clinical Decision Support for Patient Migraine Management

Migraine Clinical Trial

— CDST  

Official title:

Clinical Decision Support for Patient Migraine Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706794
• Other study ID #: 2015-5743
• Secondary ID: 1K23NS096107-01
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: March 13, 2022

Study information

• Verified date: September 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 13, 2022
• Est. primary completion date: March 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Clinical Decision Support Tool
Tailored education provided via a smartphone application.
• Headache Education
Non-tailored education provided via a smartphone application.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 6 of the Treatment
Primary	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.	Month 6 of the Treatment
Primary	Adherence to Preventive Behavioral Strategies	Number of adherent days/month	Month 6 of the Treatment
Secondary	Adherence to preventive medication	Number of adherent days/month	Month 6 of the Treatment
Secondary	Headache days	Number of headache days/month	Month 6 of the Treatment
Secondary	Average head pain	Average of daily head pain assessments/month	Month 6 of the Treatment
Secondary	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.	Month 6 of the Treatment
Secondary	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.	Month 6 of the Treatment
Secondary	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.	Month 6 of the Treatment