- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03099811
Financial Incentives to Reduce Pediatric Tobacco Smoke Exposures
19 novembre 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
147
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Maryland
-
Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
2 ans à 12 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
Autres noms:
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.
Autres noms:
|
|
Autre: Intervention: Smoking cessation program
Caregiver and a social network member will be enrolled in a state-sponsored smoking cessation program.
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pediatric secondhand smoke exposures
Délai: 6 months
|
Monthly measurement of pediatric secondhand smoke exposures.
Secondhand smoke exposures will be measured using salivary cotinine levels.
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nicotine biomarkers
Délai: 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.
|
6 months
|
|
Air nicotine
Délai: 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.
|
6 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Mandeep S Jassal, MD, Johns Hopkins University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2017
Achèvement primaire (Réel)
1 novembre 2018
Achèvement de l'étude (Réel)
1 novembre 2018
Dates d'inscription aux études
Première soumission
17 mars 2017
Première soumission répondant aux critères de contrôle qualité
28 mars 2017
Première publication (Réel)
4 avril 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 novembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 novembre 2018
Dernière vérification
1 novembre 2018
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IRB00064875
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .