Trial Outcomes & Findings for Interventions to Help More Low-income Smokers Quit (NCT NCT04311983)

NCT ID: NCT04311983

Last Updated: 2024-10-10

Results Overview

Percentage of participants who have 7 day smoking abstinence

Recruitment status

COMPLETED

Study phase

Target enrollment

1973 participants

Primary outcome timeframe

6 month follow-up

Results posted on

2024-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Tobacco Quitline Only Smokers in this study group will be offered their state Tobacco Quitline programs	Tobacco Quitline Plus Smoke Free Homes Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention
Overall Study STARTED	987	986
Overall Study COMPLETED	558	521
Overall Study NOT COMPLETED	429	465

Reasons for withdrawal

Reasons for withdrawal
Measure	Tobacco Quitline Only Smokers in this study group will be offered their state Tobacco Quitline programs	Tobacco Quitline Plus Smoke Free Homes Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention
Overall Study Lost to Follow-up	421	456
Overall Study Incomplete survey	7	9
Overall Study Death	1	0

Baseline Characteristics

Interventions to Help More Low-income Smokers Quit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tobacco Quitline Only n=987 Participants Smokers in this study group will be offered their state Tobacco Quitline programs	Tobacco Quitline Plus Smoke Free Homes n=986 Participants Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention	Total n=1973 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	51 years n=7 Participants	51 years n=5 Participants
Sex/Gender, Customized Male	317 Participants n=5 Participants	304 Participants n=7 Participants	621 Participants n=5 Participants
Sex/Gender, Customized Female	665 Participants n=5 Participants	677 Participants n=7 Participants	1342 Participants n=5 Participants
Sex/Gender, Customized Unknown	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants	52 Participants n=7 Participants	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	939 Participants n=5 Participants	928 Participants n=7 Participants	1867 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	456 Participants n=5 Participants	463 Participants n=7 Participants	919 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	405 Participants n=5 Participants	406 Participants n=7 Participants	811 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Asian American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	37 Participants n=5 Participants	27 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	65 Participants n=5 Participants	52 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Unknown/Missing	7 Participants n=5 Participants	18 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	987 participants n=5 Participants	986 participants n=7 Participants	1973 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month follow-up

Population: Participants were not included if they were lost to follow-up or were duplicate enrollees.

Percentage of participants who have 7 day smoking abstinence

Outcome measures

Outcome measures
Measure	Tobacco Quitline Only n=560 Participants Smokers in this study group will be offered their state Tobacco Quitline programs	Tobacco Quitline Plus Smoke Free Homes n=530 Participants Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention
7day Point Prevalence for Smoking	78 Participants	83 Participants

SECONDARY outcome

Timeframe: Baseline and 3-month follow-up

Population: At baseline, participants weren't included if they were duplicate entries. At 3-month follow-up, participants weren't included if they were duplicated entries or if they were lost to follow-up. Also, in Arm 2 at 3-month follow-up, if participants had chosen the quitline at baseline and did not quit, they were not re-offered the quitline; they were only offered Smoke-Free Homes. This was a planned part of the study design.

* All participants are asked at baseline if they are interested in trying the \<STATE\> tobacco quitline. Some participants are asked this question again at the 3-month follow-up * The probability is the proportion who answer "yes". * Due to our study design, at 3-month follow-up, Tobacco Quitline plus Smoke Free Homes participants were only offered the Quitline if they had not chosen it at baseline. The proportion in the table is the number of participants who accepted the Quitline divided by number who were offered the Quitline.

Outcome measures

Outcome measures
Measure	Tobacco Quitline Only n=987 Participants Smokers in this study group will be offered their state Tobacco Quitline programs	Tobacco Quitline Plus Smoke Free Homes n=986 Participants Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention
Proportion of Participants Who Accept the Tobacco Quitline Program Baseline	592 Participants	587 Participants
Proportion of Participants Who Accept the Tobacco Quitline Program 3-month follow-up	385 Participants	142 Participants

Adverse Events

Tobacco Quitline Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Tobacco Quitline Plus Smoke Free Homes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew Kreuter, Ph.D.

Washington University School of Medicine

Phone: 314-935-3701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place