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NCT04907045 · ClinicalTrials.gov registry record · NA
An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 1,552
- Enrollment target
NCT04907045 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 1,552 participants.
The verdict
NCT04907045, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,552 participants
- Enrollment target
Study Summary
The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.
Interventions
- BEHAVIORAL Health Coaching
- BEHAVIORAL Practice Facilitation
- BEHAVIORAL Standard Implementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,552 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2023-12-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04907045
The ClinicalTrials.gov registry entry for NCT04907045 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,552 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Health Coaching is the first listed.
NCT04907045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04907045 about?
NCT04907045 is a clinical study titled "An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care". The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality...
What is the current status of trial NCT04907045?
This trial is currently completed. It is a NA study. The enrollment target is 1,552 participants. The study started on 2021-05-06. Estimated completion is 2023-12-04.
What interventions are being tested in trial NCT04907045?
The interventions under investigation include: Health Coaching (BEHAVIORAL), Practice Facilitation (BEHAVIORAL), Standard Implementation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04907045?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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