- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02490566
Enhanced Primary Care and Technology for Children With Chronic Disease
Piloting Enhanced Pediatric Care for Children With Chronic Condition/Technology Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants will be recruited from an outpatient clinic site with diagnoses of overweight, obesity or asthma.
There will be a total of 6 visits during the study at approximately 1 month intervals. During the first and last visits, pre- and post-intervention assessment points, quality of life, adherence to medical regimen, physical activity and dietary habits will be gathered. During the follow-up visits, only quality of life will be surveyed. At the initial visit, for overweight children, the patients will be assessed for their behaviors and attitudes regarding eating, physical activity, sedentary time and motivation. If the patient has asthma, the pediatrician will assess understanding of the disease.
Throughout the course of the study the chronic condition pediatrician and behavior specialist will see patients in a consult capacity for their chronic condition, but the patient will continue to see their regular pediatrician for primary care needs. At every visit the pediatrician will review changes since the last visit, and then provide education directed at overweight/obesity and/or asthma. The behavior health specialists will then work with the patients to develop a plan on how to follow their treatment plan and achieve healthy behaviors.
All of the participants will receive access to technology in the form of a tablet computer for the duration of the study. The tablets will be installed with software to help educate patients and their families about asthma and overweight/obesity and track progress in managing them. In addition, all follow-up visits except for the final one will be done using the tablets and a video-conferencing app.
For the first and last visits, all patients will be seen in-person in the clinic. All of the follow-up visits will be done via a video-conferencing app on the tablet computers.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Florida
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Miami, Florida, États-Unis, 33161
- Borinquen Health Care Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients who receive care at the Borinquen Clinic
- Aged five through 18, inclusive
- Diagnosis of asthma (requiring medication) or overweight (greater than or equal to 85% for age).
- Fluent in English or Spanish.
- Parents/Guardians must be fluent in English or Spanish.
Exclusion Criteria:
- None.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Technology Arm
Tablet computer with chronic disease apps will be given to patients.
This tablet will also be used for follow-up visits done via video conferencing.
Intervention: Telehealth.
|
Tablet with chronic disease apps will be given to this group, apps will be focused on patient's condition.
Follow-up visits will be conducted through video-conferencing.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of participants compliant with supportive care visits
Délai: month 6
|
Measure supportive care visits attended by participants
|
month 6
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Effect of telehealth on participants knowledge of their chronic condition
Délai: month 6
|
Change in knowledge surveys given pre- and post-intervention.
|
month 6
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Judy Schaechter, M.D., M.B.A., University of Miami
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20140732
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