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NCT04235712 · ClinicalTrials.gov registry record
Implementation of Harmonized Depression Outcome Measures in a Health System
A clinical trial, sponsored by OM1.
- Completed
- Registry status
- 5
- Enrollment target
NCT04235712: Completed study, sponsored by OM1.
NCT04235712 is a clinical trial that has completed, run by OM1. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04235712 has completed, sponsored by OM1.
- COMPLETED
- Registry status
- 5 participants
- Enrollment target
Study Summary
Working with a health system, the investigators will recruit practices to participate in the pilot study, consent and enroll patients with major depressive disorder, and collect the PHQ-9 from those patients at three timepoints (baseline, 6 months post-enrollment, and 12 months post-enrollment). The PHQ-9 will be captured either at an office visit or directly from patients. The investigators will build and implement an open-source SMART on FHIR app to collect key data from the EHR, combine that data with the PHQ-9 results, and present the measurements back to the clinicians. The investigators will then obtain feedback from clinicians on the value and usefulness of the app.
Primary Outcome
Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide, reported in 12-month intervals.
Interventions
- OTHER Harmonized Depression Outcome Measures
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-11-17 |
| Est. Completion | 2021-05-15 |
What the finished NCT04235712 record still lists
NCT04235712 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Harmonized Depression Outcome Measures is the first listed.
NCT04235712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04235712 about?
NCT04235712 is a clinical study titled "Implementation of Harmonized Depression Outcome Measures in a Health System". Working with a health system, the investigators will recruit practices to participate in the pilot study, consent and enroll patients with major depressive disorder, and collect the PHQ-9 from those patients at three timepoints (baseline, 6 months post-enrollment, and 12 months post-enrollment). The...
What is the current status of trial NCT04235712?
This trial is currently completed. The enrollment target is 5 participants. The study started on 2020-11-17. Estimated completion is 2021-05-15.
What interventions are being tested in trial NCT04235712?
The interventions under investigation include: Harmonized Depression Outcome Measures (OTHER).
Who is sponsoring clinical trial NCT04235712?
This trial is sponsored by OM1, which has 2 total clinical trials registered on ClinicalTrials.gov.
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