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Completed

NCT Number: NCT06051474

Treating Caregivers Who Smoke at AFCH

The purpose of this research study is to 1) see if a smoking cessation program is something that caregivers will use while their child is hospitalized, 2) see if caregivers think this program is something we should institute across the hospital, and 3) see if this program can help caregivers reduce their smoking.

Participants will:

* Complete a survey regarding smoking behavior and thoughts about quitting; * Undergo a 20-minute counseling session; and, * Use nicotine patches and mini-lozenges for 2 weeks

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

About this study

All participants will receive a one-time visit with the study physician. This visit will consist of a brief counseling session. Counseling sessions will last approximately 20 minutes and cover the 3 objectives of 1) review participants' motivation for smoking and for quitting; 2) use the information on participants' motives to provide tailored education regarding a) benefits of quitting smoking to the caregiver and the child, b) strategies to reduce nicotine withdrawal symptoms/urges to smoke during the hospitalization, and c) benefits of smoke-free home and car rules; and, 3) review smoking cessation resources.

After the counseling session, participants will be provided a 2-week supply of nicotine patches and nicotine mini-lozenges, along with instructions for their use. The study physician will review how to use the medication, dosing, benefits of use, and potential side effects of use.

Within 24 hours of discharge, participants will be contacted to complete a post-intervention survey, which will assess nicotine replacement therapy (NRT) use during the hospitalization and likelihood that the participant would recommend program implementation in the hospital. Smoking behavior during the child's hospitalization will be examined, including assessments of 1) number of cigarettes smoked per day and 2) number of times participant left the child's bedside to smoke per day. Participant's self-efficacy and interest in quitting smoking will be assessed, using the same questions from the pre-intervention survey, to assess for changes after the intervention.

Participants will be contacted 2 weeks after discharge with a link to complete the follow-up survey to again assess current smoking status, use of NRT post-hospitalization, self-efficacy and interest in quitting smoking, establishment of smoke-free home and car rules, and interest in ongoing smoking cessation treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized child will have a 'yes' response to the screening question, "Does anyone in your household smoke"
  • Hospitalized child is expected to be admitted for >24 hours
  • Caregiver is at least 18 years of age
  • Participant self-identifies as the primary caregiver of the hospitalized child during the hospitalization
  • Participant smokes ≥5 cigarettes per day
  • Participant is willing and able to use NRT
  • Participant is not currently pregnant, trying to get pregnant, or breastfeeding and willing to use acceptable birth control for duration of medication use
  • Participant is willing to comply with all study procedures and be available for the duration of the study

Exclusion criteria

  • Contraindication to NRT use (pregnancy, myocardial infarction in past 2 weeks)
  • Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to use it
  • Current use of smoking cessation medications (any NRT, bupropion, varenicline)
  • Caregiver's child is being cared for by study physician (Dr. Brian Williams)
  • Need for an interpreter

Treatment and study plan

Nicotine Replacement Product

Drug

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.

Primary outcomes

  1. Enrollment in Study

    Time frame: Study recruitment, approximately 6 months

    Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll

  2. NRT Use

    Time frame: 2 weeks post-discharge, up to 4 weeks

    Number of participants who use the NRT provided

  3. Acceptability of Smoking Intervention

    Time frame: 2 weeks post-discharge, up to 4 weeks

    Self-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.

Secondary outcomes

  1. Change in Number of Cigarettes Smoked Per Day

    Time frame: Baseline to 2 weeks post-discharge, up to 4 weeks

    Self-report by participants via survey

  2. Change in Trips Outside

    Time frame: From admission to discharge, up to 4 weeks

    Self-report by participant via survey

  3. Change in Self-confidence in Quitting Smoking

    Time frame: Baseline to 2 weeks post-discharge, up to 4 weeks

    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.

  4. Change in Motivation to Quit Smoking

    Time frame: Baseline to 2 weeks post-discharge, up to 4 weeks

    Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no motivation to quit smoking and 7 indicating extreme motivation.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Treating Nicotine Addiction in Caregivers of Children at American Family Children's Hospital

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2023
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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