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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: Completed NA study, sponsored by Kaiser Permanente.
NCT04907045 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 1,552 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module
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 |
What the finished NCT04907045 record still lists
NCT04907045 is an interventional study that assigns participants to a tested intervention. Its 1,552 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 3 interventions - of which Health Coaching is the first listed.
NCT04907045 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04907045's enrollment target sits among peer trials
1,552 64th of 2000 higher than 1,937 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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