- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03397524
Tailored Drug Titration Through Artificial Intelligence (ARTERY)
Tailored Drug Titration Through Artificial Intelligence: an Interventional Study
Aperçu de l'étude
Description détaillée
The goal of the proposed research is to test a connected medication management platform technology to address medication optimization and non-adherence in chronic disease management. Chronic diseases (such as hypertension, heart failure, diabetes, coronary disease, etc.) are the main causes of morbidity, mortality and healthcare expense in the United States. Poor medication adherence and mismatches in the treatment (due to patient's reported side effect, complexity of treatment, and suboptimal efficacy of a chosen pharmacological treatment) are a major reason of failure in the management of chronic disease. The platform tested in this award will evaluate a complex machine-learning algorithm in treatment optimization for one of the chronic conditions, namely hypertension. The results of the proposed randomized clinical trial, if successful, will lead to a change in the treatment paradigm for chronic diseases. The principal investigator has just completed a pilot study in conjunction with Optima Inrwgrated Health, Inc. (i.e. PRECISION) to successfully test the medication management platform technology and its integration with the electronic medical record (EPIC® platform).
Optima-for-Blood Pressure (O4BP) is a cloud-based artificial intelligence clinical decision support system (CDSS) that evaluates patient status updates in real-time to provide advanced decision recommendations for medication treatment changes, when needed, personalized to each patient. O4BP provides a multiparameter (age, gender, ethnicity, current treatment, comorbidities, side-effects, laboratory values, compliance) overall score computation that ranks possible treatment changes in order of % improvement over current treatment. The goal of the study is to test if blood pressure management by using the O4BP CDSS is superior to standard of care (SOC) (i.e. blood pressure management during office visits).
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94123
- University of California San Francisco
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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:
- Two or more blood pressure readings of ≥ 150/95 mmHg during primary care office visits in the Department of General Medicine within the last 6 months
- Therapy with medications from at least 1 anti-hypertensive pharmacological agents at the time of the last office visit
- At least minimally "tech-savvy" defined as Ownership of a compatible smartphone Ability to access the internet
Exclusion Criteria:
- Inability to operate a blood pressure cuff
- Incompatible smartphone device (Galaxy S5 Android 5.0)
- Less than minimally "tech-savvy," defined as inability to use the Internet
- Non-compliance with medical follow-up (frequent "no shows")
- Planned coronary revascularization in the next 12 months
- Myocardial infarction, coronary revascularization, stroke, cardiac or aortic surgery in the previous 90 days
- GFR < 30 (CKD stage IV/ V)
- Primary care provider rules out the patient due to comorbidities or other factors
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: optima4BP
optima4BP will receive several types of data to personalize the participant's medication treatment.
The data include: remotely measured blood pressure (BP), and information on current medication treatment as well as health updates posted in Epic Electronic Record.
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optima4BP will provide the treating physician with a treatment action recommendation for consideration.
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Aucune intervention: Standard of Care
The participants randomized to the Standard of Care will follow usual care, as currently followed at the University of California San Francisco.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Reduction in systolic BP [SBP] (mmHg) measure in the office
Délai: 12 months
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optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]
Délai: 12 months
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optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care baseline through 12 months of enrollment.
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12 months
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Incidence of Adverse Events
Délai: 12 months
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Frequency and severity of adverse events (AEs) between baseline and the end of the study.
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12 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Gabriela Voskerician, Optima Integrated Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
- 17-21426
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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