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Digital Therapeutics
Digital Treatments for Substance Use Disorders (DIGITS Trial)
N/A
Waitlist Available
Led By Joseph E Glass, PhD, MSW
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months from the patients index visit date
Awards & highlights
DIGITS Trial Summary
This trial is designed to study how best to digital treatments for opioids and other substance use disorders in primary care. The study will compare the effectiveness of two implementation strategy interventions: health coaching and practice coaching.
Who is the study for?
This trial is for adults over 18 who have visited a participating primary care clinic and screened positive for substance use either on the day of their visit or in the past year. They must be patients at clinics where at least one clinician is trained to use reSET/reSET-O digital treatments.Check my eligibility
What is being tested?
The DIGITS Trial tests how well two strategies, health coaching and practice facilitation, help implement digital treatments (reSET and reSET-O) for substance abuse in primary care settings. Clinics are randomly chosen to receive these strategies during a 12-month period with an additional follow-up phase.See study design
What are the potential side effects?
Since this trial focuses on implementation strategies rather than medications, it does not directly involve medical side effects. However, participants may experience varying levels of engagement or satisfaction with the digital treatment process.
DIGITS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months from the patients index visit date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months from the patients index visit date
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fidelity of patients' use of the digital therapeutic to clinical recommendations
Reach of the digital therapeutic to patients in the primary care clinic
Secondary outcome measures
Economic costs
Engagement
Other outcome measures
Abstinence
Fidelity-2
Reach-2
+2 moreDIGITS Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Standard Implementation Plus Practice FacilitationExperimental Treatment2 Interventions
The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation.
Group II: Standard Implementation Plus Health Coaching and Practice FacilitationExperimental Treatment3 Interventions
The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.
Group III: Standard Implementation Plus Health CoachingExperimental Treatment2 Interventions
The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O.
Group IV: Standard ImplementationActive Control1 Intervention
All primary care clinics will implement reSET and reSET-O using standard implementation approach.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard implementation
2021
N/A
~10
Health Coaching
2018
N/A
~1880
Practice Facilitation
2007
N/A
~17800
Find a Location
Who is running the clinical trial?
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,100,828 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,605,593 Total Patients Enrolled
Joseph E Glass, PhD, MSWPrincipal InvestigatorKaiser Permanente
2 Previous Clinical Trials
740 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The healthcare provider who will be administering the treatment is trained in using reSET or reSET-O.I am 18 years old or older.I have chosen not to participate in any research through my health system.I am a patient seeking treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Implementation
- Group 2: Standard Implementation Plus Health Coaching
- Group 3: Standard Implementation Plus Practice Facilitation
- Group 4: Standard Implementation Plus Health Coaching and Practice Facilitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT05160233 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are joining this medical experiment?
"Affirmative, clinicaltrials.gov attests that this experiment is still recruiting individuals to participate in the study. This trial was first made public on December 9th 2021 and had its most recent revision as of January 3rd 2022. 13000 participants are required from a singular site for completion of the research."
Answered by AI
Is enrollment currently available for this research endeavor?
"Clinicaltrials.gov confirms that this clinical trial is currently in search of participants, having been initially posted on December 9th 2021 and modified as recently as January 3rd 2022."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
What site did they apply to?
Kaiser Permanente Washington
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been struggling with opioid addiction for the past 10 years. I will get some clean time then I will relapse. I am open to any new approach to help me stay sober. I would love the opportunity to try this out. I don't feel I stumbled across this by mistake.
PatientReceived 2+ prior treatments
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