Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-03 @ 2:13 PM
Study NCT ID:
NCT03194958
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Helping Poor Smokers Quit
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.
Detailed Description:
2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered "enrolled". Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day.
Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.
Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA201429 | NIH | None | https://reporter.nih.gov/quic… | View |