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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 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 112 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04281030
The ClinicalTrials.gov registry entry for NCT04281030 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PMR (Progressive muscle relaxation therapy) is the first listed.
NCT04281030 reports 0 study locations.
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.
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