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NCT05671380 · ClinicalTrials.gov registry record · NA
A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
A NA study of Cardiovascular Diseases and Smoking Cessation, sponsored by University of Minnesota.
- Active
- Registry status
- NA
- Development phase
- 700
- Enrollment target
- 3
- Study locations
NCT05671380: Active NA study of Cardiovascular Diseases and Smoking Cessation, sponsored by University of Minnesota.
NCT05671380 is a NA study of Cardiovascular Diseases and Smoking Cessation that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 700 participants, below the 26,972-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05671380, a NA study of Cardiovascular Diseases and Smoking Cessation, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 700 participants
- Enrollment target
- 3
- Study locations
Study Summary
This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.
Primary Outcome
7-day point prevalence abstinence from combustible tobacco will be verified at 18 months post-enrollment. Surveys to self-report abstinence will be provided at 6, 12, and 18 months. Self-reported smoking abstinence will be verified using expired carbon monoxide as the primary method with salivary cotinine as an alternative method at the 18-month follow-up. Participants with a CO of \< 6 ppm will be considered abstinent. Participants with a salivary cotinine \< 10 ng/ml will be considered abstin
Conditions Studied
Interventions
- BEHAVIORAL Longitudinal Proactive Outreach (LPO).
- BEHAVIORAL Ask-Advice-Connect (AAC)
Study Locations (3)
Minnesota
- Hennepin Healthcare - Minneapolis
- University of Minnesota - Minneapolis
- Mayo Clinic Health System - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2023-05-05 |
| Est. Completion | 2026-06-24 |
| Phase | NA |
What the registry record for NCT05671380 still lists
NCT05671380 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 26,972-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 2 interventions - of which Longitudinal Proactive Outreach (LPO). is the first listed.
NCT05671380 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05671380 about?
NCT05671380 is a clinical study titled "A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities". This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. ...
What is the current status of trial NCT05671380?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 700 participants. The study started on 2023-05-05. Estimated completion is 2026-06-24.
What conditions does trial NCT05671380 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Smoking Cessation, Smoking, Tobacco Use, Tobacco Use Cessation.
What interventions are being tested in trial NCT05671380?
The interventions under investigation include: Longitudinal Proactive Outreach (LPO). (BEHAVIORAL), Ask-Advice-Connect (AAC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05671380?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05671380 being conducted?
This trial has 3 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05671380's enrollment target sits among peer trials
700 78th of 300 higher than 222 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases 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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