- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01938807
Audio Health Engagement Analysis in Diabetes: The AHEAD Study
Despite multidisciplinary care and advancements in therapeutics and technology, health outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to poor outcomes is suboptimal diabetes management in pediatric patients and their families. The premise of this research project is that patients and families do not have adequate resources to meet the level of diabetes management that translates to better outcomes. Therefore, we will give them a valuable tool to improve their overall management. The tool is CareCoach.
Research shows that enhancing communication and partnership among patients, parents, and providers is especially critical for optimal outcomes in pediatric diabetes. Communication gaps and conflict can complicate the already complex provider-patient interactions and daily management. We have therefore designed, refined, and made available to consumers a new mobile-based intervention, CareCoach, to improve communication; build trust among providers, patients and parents; and increase overall satisfaction with the quality of diabetes care. This web/mobile application is designed to help patients unobtrusively audio record their clinical encounters, track their medical consults and treatment plans, review information from past visits, create visit discussion guides, and track adherence to medication and dosing schedules. In addition, because mobile-based applications are inexpensive to administer, portable, and available at all times of day, CareCoach holds great promise for communication coaching and contributing to improved diabetes management.
We hypothesize that CareCoach will improve patient-parent-provider communications, build patient-parent-provider trust, and increase overall satisfaction with clinical interactions in a sample of children with type 1 diabetes and their parents. These improvements will lead to significant gains in diabetes management, setting the stage for optimal health outcomes. To test the effectiveness of CareCoach, we will conduct a randomized controlled trial comparing the CareCoach intervention to standard care in a sample of 60 children with type 1 diabetes and their parents.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- parent of a child with diagnosis of type 1 diabetes for at least one year
- parent of a child with type 1 diabetes between the ages of 7-12
- provide informed consent in English
- have access to the internet from home
Exclusion Criteria:
- no access to the internet
- shorter duration of type 1 diabetes than one year
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
The intervention group receives the CareCoach mobile application
|
|
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Comparateur actif: Control
The control group receives standard care.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Diabetes Management
Délai: 6 months post-baseline
|
6 months post-baseline
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Hemoglobin A1c
Délai: 6 months post-baseline
|
6 months post-baseline
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Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
|
Satisfaction and usability of the mobile application
Délai: 6 months post-baseline
|
6 months post-baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Diana Naranjo, PhD, University of California, San Francisco
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
- UCSF 12-09213
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