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Financial Incentives to Reduce Pediatric Tobacco Smoke Exposures

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ClinicalTrials.gov Identifier: NCT03099811
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Secondhand smoke exposure (SHSe) is one of the most common and potentially modifiable environmental triggers for asthma. Financial incentivization may serve as an effective modality to reduce SHSe among pediatric asthmatics with potential down-stream benefits on improved asthma control and subsequent reduced healthcare utilization. This study plans on testing the feasibility and effectiveness of financial incentives to decrease SHSe, derived from primary caregivers and a member of their social network, of children with persistent asthma.

Condition or disease Intervention/treatment Phase
Asthma Incentives Tobacco Smoking Behavioral: Incentive plan Behavioral: Smoking cessation Not Applicable

Detailed Description:
The impact of continued cigarette usage is profoundly felt not only upon the primary smoker, but also among children where SHSe is linked with asthma exacerbations. Children with caregivers who are active smokers are more likely to utilize acute healthcare resources and miss more days of school due to asthma symptoms. Issues of pediatric smoke exposure are notably higher among low-income populations. This particular group has a greater amount of financial strain that increases their desire to cease smoking but is among the least successful at accomplishing this task. Aggressive marketing campaigns by cigarette companies have specifically targeted the urban poor but similar techniques by public health officials, though on a much diminished scale, have yet to completely counter the hold that this addictive product has on members of lower socioeconomic status. One approach that has demonstrated efficacy in reducing smoking in resistant populations emphasizes financial incentives. Incentives may provide a substitute for the gratification derived from nicotine if they are properly structured. This proposal applies a contingency management schema among caregivers of pediatric asthmatics and a member of their caregiver's social network - both of whom are likely major contributors to the child's total secondhand smoke exposure. A pilot two-arm randomized-control trial will be employed over a 6-month time interval.The study population will consist of the primary caregiver and a selected member of their social network, both of who are known active smokers, and contemplating smoking cessation; both individuals spend time (either indoors or outdoors) with the asthmatic child. We will recruit 50 caregiver-child-social network triads among a population of children diagnosed with uncontrolled, persistent asthma and routinely exposed to high levels of SHSe. Caregivers and members of their social network who are both active smokers will be randomized to receive standard smoking cessation strategies (n=25 triads) with or without financial incentives (n=25 triads). SHSe will be measured directly using salivary cotinine levels from children and home air nicotine levels. Caregiver and social network member smoking behaviors will be measured by nicotine biomarkers; both test results will be the basis for incentive payments. Asthma control will be evaluated using validated questionnaires and review of the participant's electronic health record.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Contingency Management for Controlling Secondhand Smoke Exposures Among Asthmatic Children
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention: Financial incentives + Smoking cessation program
Caregiver and a social network member will receive financial incentives, in additional to enrollment in a state-sponsored smoking cessation program, based on nicotine biomarker measurements.
Behavioral: Incentive plan
The caregiver and designated social network member can each receive monthly financial incentives over the 6 month time interval. Additional monthly incentives will be received at 3- and 6-months if the participant's previous two monthly biomarker levels were below the lower-limit cutoff.
Other Name: Contingency management

Behavioral: Smoking cessation
Participants who wish to quit smoking will be referred upon study recruitment to the smoking cessation program that is provided at no-cost by the Maryland Department of Health and Mental Hygiene (DMMH). The DMMH provides standard counseling and nicotine replacement pharmacotherapies for clients and is offered online or at six health centers throughout Baltimore City.
Other Name: Tobacco cessation

Intervention: Smoking cessation program
Caregiver and a social network member will be enrolled in a state-sponsored smoking cessation program.
Behavioral: Smoking cessation
Participants who wish to quit smoking will be referred upon study recruitment to the smoking cessation program that is provided at no-cost by the Maryland Department of Health and Mental Hygiene (DMMH). The DMMH provides standard counseling and nicotine replacement pharmacotherapies for clients and is offered online or at six health centers throughout Baltimore City.
Other Name: Tobacco cessation




Primary Outcome Measures :
  1. Pediatric secondhand smoke exposures [ Time Frame: 6 months ]
    Monthly measurement of pediatric secondhand smoke exposures. Secondhand smoke exposures will be measured using salivary cotinine levels.


Secondary Outcome Measures :
  1. Nicotine biomarkers [ Time Frame: 6 months ]
    Monthly measurements of nicotine biomarkers to objectively assess tobacco usage. This will serve as the trigger for monthly financial incentives for those allocated to the intervention group.

  2. Air nicotine [ Time Frame: 6 months ]
    Home air nicotine levels will be measured to assess if tobacco-derived indoor air pollutant levels will decline with the intervention. Air nicotine levels will be acquired through passive air samplers and measured using gas chromatography.



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary caregiver aged greater than 18 years who is an active smoker.
  • Child aged 2-12 years of age who meets clinical criteria for persistent asthma and has nicotine biomarker levels consistent with secondhand smoke exposure
  • Designated social network member who is an active smoker
  • Residence in Baltimore City

Exclusion Criteria:

  • Child has current diagnosis of another major pulmonary disease or other significant medical co-morbidity
  • Use of electronic cigarettes (e-cigarettes) by the adult-enrolled participants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099811


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Mandeep S Jassal, MD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03099811     History of Changes
Other Study ID Numbers: IRB00064875
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No