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NCT04281030 · ClinicalTrials.gov registry record · NA
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 112
- Enrollment target
NCT04281030: Completed NA study, sponsored by NYU Langone Health.
NCT04281030 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 112 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04281030, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BEHAVIORAL PMR (Progressive muscle relaxation therapy)
- BEHAVIORAL Monitored Usual Care (MUC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2019-06-30 |
| Est. Completion | 2022-03-30 |
| Phase | NA |
What the finished NCT04281030 record still lists
NCT04281030 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which PMR (Progressive muscle relaxation therapy) is the first listed.
NCT04281030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04281030 about?
NCT04281030 is a clinical study titled "Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department". 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 stud...
What is the current status of trial NCT04281030?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2019-06-30. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT04281030?
The interventions under investigation include: PMR (Progressive muscle relaxation therapy) (BEHAVIORAL), Monitored Usual Care (MUC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04281030?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04281030's enrollment target sits among peer trials
112 813th of 2000 higher than 1,185 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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