Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

Migraine Clinical Trial

Official title:

Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281030
• Other study ID #: 16-00548 - 2
• Secondary ID: 1K23AT009706-01
• Status: Completed
• Phase: N/A
• Start date: June 30, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot feasibility acceptability study to examine the impact of smartphone-based progressive muscle relaxation (PMR) on migraine quality of life, frequency, intensity, and disability. Feasibility is measured by: a) Proportion of patients who enrolled in the study/were recruited for the study, b) Number of days PMR practiced/week as determined with the backend analytics in the RELAXaHEAD app, c) Minutes/day spent doing PMR, d) Reasons for non-adherence. Acceptability is measured by: a) Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality b) Willingness to repeat a similar treatment intervention in the future (Definitely No/Probably No/Unsure/Probably Yes/ Definitely Yes) c) Attrition. In addition, whether use of electronically based PMR introduced in the emergency department (ED) improves migraine quality of life (MSQv2) and migraine related disability (MIDAS) at 3 months post ED-discharge (or post enrollment date if recruited post ED discharge) compared to those who are not introduced to PMR will be assessed. All participants will be asked to track their headache frequency and intensity using our smartphone application (app) and will be asked to complete migraine quality of life assessments and migraine related disability at follow-up.

Description:

While explaining the study, potential participants will be assured that they will receive all of the medication for their acute headache that they would otherwise receive. Once consented, participants will be randomized to PMR therapy or monitored usual care (MUC). Participants will be told that either group is being tested as an enhancement to the care they typically get in the ED for headache. (At the end, they will be informed which group they were in.) The study team will collect participants' health histories (biologic variables) and baseline data in REDCap, download the app onto subjects' smartphones, and conduct the sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Meets migraine criteria and has 4+ headache days a month

Exclusion Criteria:

• Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year
• Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
• Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
• Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
• Not having a smartphone

Related Conditions & MeSH terms

• Emergencies
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• PMR (Progressive muscle relaxation therapy)
Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day.
• Monitored Usual Care (MUC)
Subjects will be given basic migraine information such as evidence-based ways to treat migraine: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores	The MSQv2 is a 14-item self-assessment of how migraines affect a patient's life. 7 of the items assess the Role Function-Restrictive (RFR) Domain, which measures the functional impact of migraine through limitations on daily social and work activities.; Items are ranked on 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of time; 5 = Most of the time; and 6 = All of the time.; The raw dimension score is computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.	Baseline, Month 3 Post-Discharge
Primary	Change in MSQv2 - Role Function Preventive (RFP) Domain Scores	The MSQv2 is a 14-item self-assessment of how migraines affect a patient's life. 4 of the items assess the Role Function-Preventive (RFP) Domain, which measures the impact of migraine through prevention of daily work and social activities; Items are ranked on 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of time; 5 = Most of the time; and 6 = All of the time.; The raw dimension score is computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.	Baseline, Month 3 Post-Discharge
Primary	Change in MSQv2 - Emotional Function (EF) Domain Scores	The MSQv2 is a 14-item self-assessment of how migraines affect a patient's life. 3 of the items assess the Emotional Function (EF) Domain, which measures the emotional impact of migraine.; Items are ranked on 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of time; 5 = Most of the time; and 6 = All of the time.; The raw dimension score is computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.	Baseline, Month 3 Post-Discharge
Primary	Change in Migraine Disability Assessment Scale (MIDAS) Score	5-item self-administered questionnaire designed to quantify headache-related disability over a 3-month period. For each item, participants indicate the number of days over the past three months that migraine limited their ability to participant in specific activities.; The score is the sum responses. Scores are classified as follows: 0 to 5 = Little or no disability (MIDAS Grade I); 6 to 10 = Mild disability (MIDAS Grade II); 11 to 20 = Moderate disability (MIDAS Grade III); 21-40 = Severe disability (MIDAS Grade IV-A); Greater than 40 = Very severe disability (MIDAS Grade IV-B)	Baseline, Month 3 Post-Discharge
Secondary	Number of Headache Days Based on MIDAS	Information from the Migraine Disability Assessment Scale (MIDAS) questionnaire will be used to calculate the number of headache days at baseline.	Baseline