Clinical trial NCT04281030: Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
Official title: Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-02-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores
timeFrame: Baseline, Month 3 Post-Discharge
measure: Change in MSQv2 - Role Function Preventive (RFP) Domain Scores
timeFrame: Baseline, Month 3 Post-Discharge
measure: Change in MSQv2 - Emotional Function (EF) Domain Scores
timeFrame: Baseline, Month 3 Post-Discharge
measure: Change in Migraine Disability Assessment Scale (MIDAS) Score
timeFrame: Baseline, Month 3 Post-Discharge
Secondary outcomes:
measure: Number of Headache Days Based on MIDAS
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone
name: Mia Minen, MD
role: PRINCIPAL_INVESTIGATOR
References: