- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03099811
Financial Incentives to Reduce Pediatric Tobacco Smoke Exposures
19. november 2018 opdateret af: Johns Hopkins University
Contingency Management for Controlling Secondhand Smoke Exposures Among Asthmatic Children
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
147
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 12 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
Andre navne:
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.
Andre navne:
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Andet: Intervention: Smoking cessation program
Caregiver and a social network member will be enrolled in a state-sponsored smoking cessation program.
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pediatric secondhand smoke exposures
Tidsramme: 6 months
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Monthly measurement of pediatric secondhand smoke exposures.
Secondhand smoke exposures will be measured using salivary cotinine levels.
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Nicotine biomarkers
Tidsramme: 6 months
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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.
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6 months
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Air nicotine
Tidsramme: 6 months
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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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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Mandeep S Jassal, MD, Johns Hopkins University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2017
Primær færdiggørelse (Faktiske)
1. november 2018
Studieafslutning (Faktiske)
1. november 2018
Datoer for studieregistrering
Først indsendt
17. marts 2017
Først indsendt, der opfyldte QC-kriterier
28. marts 2017
Først opslået (Faktiske)
4. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IRB00064875
Plan for individuelle deltagerdata (IPD)
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