Trial Outcomes & Findings for Treating Caregivers Who Smoke at AFCH (NCT NCT06051474)
NCT ID: NCT06051474
Last Updated: 2026-04-16
Results Overview
Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
Study recruitment, approximately 6 months
Results posted on
2026-04-16
Participant Flow
Participant milestones
| Measure |
Caregivers of Hospitalized Children
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Overall Study
STARTED
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23
|
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Caregivers Who Smoke at AFCH
Baseline characteristics by cohort
| Measure |
Caregivers of Hospitalized Children
n=23 Participants
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Age, Continuous
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35.91 years
n=193 Participants
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Sex: Female, Male
Female
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14 Participants
n=193 Participants
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Sex: Female, Male
Male
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9 Participants
n=193 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=193 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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22 Participants
n=193 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=193 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=193 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=193 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=193 Participants
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|
Race (NIH/OMB)
Black or African American
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8 Participants
n=193 Participants
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Race (NIH/OMB)
White
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14 Participants
n=193 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=193 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=193 Participants
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Region of Enrollment
United States
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23 participants
n=193 Participants
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Relationship to child
Mother
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14 Participants
n=193 Participants
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Relationship to child
Father
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8 Participants
n=193 Participants
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Relationship to child
Stepparent
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1 Participants
n=193 Participants
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|
Highest level of education
Some high school
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4 Participants
n=193 Participants
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Highest level of education
High school graduate or equivalent degree
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11 Participants
n=193 Participants
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Highest level of education
Some college or 2-year technical school
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6 Participants
n=193 Participants
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Highest level of education
4-year college graduate
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2 Participants
n=193 Participants
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Reason for child's hospital admission
Respiratory
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3 Participants
n=193 Participants
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Reason for child's hospital admission
Gastrointestinal
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7 Participants
n=193 Participants
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Reason for child's hospital admission
Neurological
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5 Participants
n=193 Participants
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|
Reason for child's hospital admission
Infectious
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2 Participants
n=193 Participants
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|
Reason for child's hospital admission
Renal/Bladder
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1 Participants
n=193 Participants
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Reason for child's hospital admission
Other
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5 Participants
n=193 Participants
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Cigarettes smoked per day
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11.14 cigarettes per day
n=193 Participants
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Time between waking and smoking first cigarette
Within 5 minutes of waking
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6 Participants
n=193 Participants
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Time between waking and smoking first cigarette
6-30 minutes after waking
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9 Participants
n=193 Participants
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Time between waking and smoking first cigarette
>30 minutes after waking
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8 Participants
n=193 Participants
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Confidence in quitting
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5.17 units on a scale
n=193 Participants
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Motivation to quit
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5.17 units on a scale
n=193 Participants
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Smoking in home
Allowed
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18 Participants
n=193 Participants
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Smoking in home
Prohibited
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3 Participants
n=193 Participants
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Smoking in home
Not reported
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2 Participants
n=193 Participants
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Smoking in car
Allowed
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18 Participants
n=193 Participants
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Smoking in car
Prohibited
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4 Participants
n=193 Participants
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Smoking in car
Not reported
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1 Participants
n=193 Participants
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PRIMARY outcome
Timeframe: Study recruitment, approximately 6 monthsPopulation: The outcome measure looks at the number of people invited to enroll, which was 63, versus the number who enrolled; therefore, 63 were analyzed.
Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll
Outcome measures
| Measure |
Caregivers of Hospitalized Children
n=63 Participants
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Enrollment in Study
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36.5 percentage of people invited who enrolle
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PRIMARY outcome
Timeframe: 2 weeks post-discharge, up to 4 weeksNumber of participants who use the NRT provided
Outcome measures
| Measure |
Caregivers of Hospitalized Children
n=23 Participants
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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NRT Use
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11 Participants
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PRIMARY outcome
Timeframe: 2 weeks post-discharge, up to 4 weeksSelf-report by participant via survey. Score ranges from 1-7, with 1 indicating would not recommend implementing cessation program and 7 indicating definitely recommend implementing program.
Outcome measures
| Measure |
Caregivers of Hospitalized Children
n=23 Participants
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Acceptability of Smoking Intervention
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6.77 score on a scale
Interval 1.0 to 7.0
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SECONDARY outcome
Timeframe: Baseline to 2 weeks post-discharge, up to 4 weeksPopulation: Not all participants completed the survey
Self-report by participants via survey
Outcome measures
| Measure |
Caregivers of Hospitalized Children
n=13 Participants
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Change in Number of Cigarettes Smoked Per Day
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-6.31 cigarettes per day
Interval -18.0 to 3.0
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SECONDARY outcome
Timeframe: From admission to discharge, up to 4 weeksPopulation: Not all participants completed the survey
Self-report by participant via survey
Outcome measures
| Measure |
Caregivers of Hospitalized Children
n=22 Participants
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Change in Trips Outside
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-0.5 trips taken outside
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: Baseline to 2 weeks post-discharge, up to 4 weeksPopulation: Not all participants completed the survey.
Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no confidence in ability to quit smoking and 7 indicating extreme confidence.
Outcome measures
| Measure |
Caregivers of Hospitalized Children
n=14 Participants
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Change in Self-confidence in Quitting Smoking
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0.64 score on a scale
Standard Deviation 1.34
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SECONDARY outcome
Timeframe: Baseline to 2 weeks post-discharge, up to 4 weeksPopulation: Not all participants completed the survey
Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no motivation to quit smoking and 7 indicating extreme motivation.
Outcome measures
| Measure |
Caregivers of Hospitalized Children
n=14 Participants
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Change in Motivation to Quit Smoking
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0.93 score on a scale
Standard Deviation 1.60
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Adverse Events
Caregivers of Hospitalized Children
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caregivers of Hospitalized Children
n=23 participants at risk
Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge.
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|---|---|
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Gastrointestinal disorders
Nausea
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4.3%
1/23 • Number of events 1 • 2 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place