Teen Asthma Control Encouraging a Healthier Lifestyle (TAC)
Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Asthma that has persisted in adolescents is likely to persist into adulthood. For 25-30% of Americans, adolescence is also the period at which they experience their greatest weight gain, particularly as they approach the final stages of puberty. Asthma management may be more of a challenge in the overweight adolescent compared to a normal weight youth. Asthma related morbidity is increased in overweight patients, reflected in higher health care utilization for this subgroup. Little guidance is given to physicians caring for obese adolescents with asthma, but findings suggest that interventions designated to achieve control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g. low self-esteem, depression and low quality of life) successful interventions should incorporate a patient-centered approach.
Patient-centered care (or patient focused care) involves a partnership between the patient and the physician, shared discussion making, as well as productive communication and health promotion. The objective of this project is to collect the information necessary to develop a tailored discussion guide for use by the physician caring for the obese teen with asthma. Project results will provide an evidence base for the development and evaluation of additional patient-centered health interventions for obese adolescents with asthma. The investigators will conduct this study among patients whom eligibility can be determined using the electronic medical record (EMR). The specific aims of this proposal are to:
Qualitatively collect information on outcomes important to obese adolescents with asthma:
Create a tailored discussion guide that incorporates patient preferences and treatment goals that can be used by providers caring for overweight adolescents with asthma:
Conduct a randomized trial to determine if patient-centered and clinical outcomes improve for patients whose physicians use the tailored discussion guide compared to those who do not.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48202
- Henry Ford System
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- BMI >85th Percentile & Diagnosed with asthma; using a modification of Healthcare Effectiveness Data and Information Set (HEDIS) criteria:
- At least one emergency department visit with a principal diagnosis of asthma, or
- At least one acute inpatient claim/encounter with asthma as the principal diagnosis or at least four outpatient visits with an asthma diagnosis and at least or
- At least four asthma four outpatient visit with an asthma diagnosis and at least two asthma medications dispensed, or
- At least four asthma medications dispensed in the last 12 month
Exclusion Criteria:
- Does not meet eligibility criteria for weight and/or asthma;
- Currently enrolled in another investigational asthma management /education/weight management trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Standard Control
Teens in the control group will receive standard or usual care as provided by their physician.
|
Teens in the control group will receive standard or usual care as provided by their physician.
|
|
Autre: Intervention
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
|
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Asthma Control Test
Délai: 12 months of enrollment
|
A validated measure of asthma control
|
12 months of enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body Mass Index (BMI)
Délai: 12 months of enrollment
|
changes in participant weight
|
12 months of enrollment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christine Joseph, PhD, Henry Ford Health System
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 8298 (CTEP)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 .