- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03397524
Tailored Drug Titration Through Artificial Intelligence (ARTERY)
Tailored Drug Titration Through Artificial Intelligence: an Interventional Study
Panoramica dello studio
Descrizione dettagliata
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).
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
-
San Francisco, California, Stati Uniti, 94123
- University of California San Francisco
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
optima4BP will provide the treating physician with a treatment action recommendation for consideration.
|
|
Nessun intervento: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reduction in systolic BP [SBP] (mmHg) measure in the office
Lasso di tempo: 12 months
|
optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]
Lasso di tempo: 12 months
|
optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care baseline through 12 months of enrollment.
|
12 months
|
|
Incidence of Adverse Events
Lasso di tempo: 12 months
|
Frequency and severity of adverse events (AEs) between baseline and the end of the study.
|
12 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Gabriela Voskerician, Optima Integrated Health
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 17-21426
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .