Tailored Drug Titration Through Artificial Intelligence (ARTERY)
Tailored Drug Titration Through Artificial Intelligence: an Interventional Study
調査の概要
詳細な説明
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).
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94123
- University of California San Francisco
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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介入なし: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reduction in systolic BP [SBP] (mmHg) measure in the office
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]
時間枠: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
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Gabriela Voskerician、Optima Integrated Health
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。