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NCT04745065 · ClinicalTrials.gov registry record · NA
Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program
A NA study, sponsored by Pro-Change Behavior Systems.
- Completed
- Registry status
- NA
- Development phase
- 237
- Enrollment target
NCT04745065: Completed NA study, sponsored by Pro-Change Behavior Systems.
NCT04745065 is a NA study that has completed, run by Pro-Change Behavior Systems. The registered enrollment target is 237 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04745065, a NA study, has completed, sponsored by Pro-Change Behavior Systems.
- COMPLETED
- Registry status
- NA
- Development phase
- 237 participants
- Enrollment target
Study Summary
This study will evaluate the effectiveness of the digital + telehealth Connect2BWell program among 336 safety net patients. Adults patients with an upcoming medical medical visit, and/or who screen positive for substance use disorder (SUD) during routine SBIRT screening during their visit, will receive an email invitation from the research team to complete an online risk assessment to assess study eligibility. The assessment will include the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Patients scoring in the moderate- or high-risk range for one or more drugs--including alcohol, excluding tobacco--and who meet all other study inclusion criteria, will alternately be assigned to the Connect2BWell Condition or a Comparison Condition. ASSIST scores will be sent to the patient's Electronic Health Record (EHR). Patients assigned to the Treatment Condition will receive three brief online intervention sessions followed by dashboard-guided telehealth sessions with a study nurse, text messages, and access to a patient portal. Patients assigned to the Comparison Condition will receive an SBIRT session delivered via telehealth by a member of their clinic care team. Outcomes, assessed at baseline, 3, 6 and 9 months, include days of use of most problematic drug during the past 30 days, the ASSIST risk score of the most problematic drug, depression, well-being, satisfaction with care, and treatment uptake, if indicated. All patient-facing materials are available in English and Spanish.
Primary Outcome
Days of use will be assessed using the Timeline Followback (TLFB) method, which includes a calendar for indicating each day of use during the past 30 days. The approach has been validated for alcohol use, other drug use, and for administration by telephone and computer. The online assessment will present an interactive calendar showing the past 30 days, and ask participants to mark each day that they used their most problematic drug. Total days marked will represent days of use. Change scores wi
Interventions
- BEHAVIORAL Connect2BWell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2022-06-26 |
| Phase | NA |
What the finished NCT04745065 record still lists
NCT04745065 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Connect2BWell is the first listed.
NCT04745065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04745065 about?
NCT04745065 is a clinical study titled "Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program". This study will evaluate the effectiveness of the digital + telehealth Connect2BWell program among 336 safety net patients. Adults patients with an upcoming medical medical visit, and/or who screen positive for substance use disorder (SUD) during routine SBIRT screening during their visit, will rece...
What is the current status of trial NCT04745065?
This trial is currently completed. It is a NA study. The enrollment target is 237 participants. The study started on 2021-02-15. Estimated completion is 2022-06-26.
What interventions are being tested in trial NCT04745065?
The interventions under investigation include: Connect2BWell (BEHAVIORAL).
Who is sponsoring clinical trial NCT04745065?
This trial is sponsored by Pro-Change Behavior Systems, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04745065's enrollment target sits among peer trials
237 461st of 2000 higher than 1,540 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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