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| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
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Hypertension - a chronic condition of elevated blood pressure (BP) - is a highly prevalent condition. However, effective prevention and management of hypertension remain challenging under the current standard of care (SOC). There has been a growing recognition that one-off, irregular office BP measurements are not sufficient and that regular home BP monitoring will likely be an adjunct to conventional office BP measurements. By using artificial intelligence (AI), via the CURATE.AI platform, the goal is to use patients' BP data to rapidly generate personalized anti-hypertensive dose titrations. The main aim of this study is to assess the feasibility of CURATE.AI-assisted dose titration.
The primary aim is to assess the feasibility of CURATE.AI-assisted dose titration intervention (daily home BP monitoring via telemonitoring BotMD Care platform combined with personalized continuous dose titration based on CURATE.AI recommendations to treating physicians).
The secondary objective is to evaluate the safety and generate estimates of effect size using a small three-arm study design (N=45; 1:1:1 randomization), to inform the power analysis and sample size calculation for a larger randomized controlled trial (RCT) evaluating the efficacy and safety of the CURATE.AI-assisted dose titration intervention. The other aim is to also understand the potential efficacy of the CURATE.AI-assisted dose titration intervention to improve treatment efficacy outcomes.
The investigators hypothesize that it will be logistically and scientifically feasible to use CURATE.AI-assisted dose titration for the management of hypertension,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Telemonitoring group | Active Comparator |
| |
| AI. + Telemonitoring group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curate.AI | Device | Personalized, continuous recommendations on anti-hypertensive medication dose titration using an AI-derived platform also known as Curate.AI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Logistical feasibility of a protocol using telemonitoring and CURATE.AI-assisted dose titration. | A composite of the percentages will be use to obtain overall logistical feasibility of the protocol
| 30 days |
| Scientific Feasibility | A composite of the percentages will be use to obtain overall scientificl feasibility of the protocol
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol. | Mean change and time taken for in office BP between baseline and 1-month clinic visit towards reaching the target office systolic BP<140mmHg and diastolic BP<90mmHg. | 3 months |
| Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandra Hospital | Recruiting | Singapore | 159964 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31771394 | Background | Blasiak A, Khong J, Kee T. CURATE.AI: Optimizing Personalized Medicine with Artificial Intelligence. SLAS Technol. 2020 Apr;25(2):95-105. doi: 10.1177/2472630319890316. Epub 2019 Nov 26. | |
| 38264697 | Derived | Truong ATL, Tan SB, Wang GZ, Yip AWJ, Egermark M, Yeung W, Lee VV, Chan MY, Kumar KS, Tan LWJ, Vijayakumar S, Blasiak A, Wang LYT, Ho D. CURATE.AI-assisted dose titration for anti-hypertensive personalized therapy: study protocol for a multi-arm, randomized, pilot feasibility trial using CURATE.AI (CURATE.AI ADAPT trial). Eur Heart J Digit Health. 2023 Oct 24;5(1):41-49. doi: 10.1093/ehjdh/ztad063. eCollection 2024 Jan. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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This is a 3 armed study.
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| Telemonitoring | Behavioral | Patients will report their blood pressure to a telemonitoring health platform |
|
-Percentage of participants with office systolic BP<140mmHg and/OR diastolic BP<90mmHg at 1-month. |
| 3 months |
| Generate pilot efficacy of telemonitoring and CURATE.AI-assisted dose titration protocol. | -Time in therapeutic range: the percentage of home BP measurements recorded within the target home range during the CURATE.AI-assisted efficacy-driven dose recommendation stage | 3 months |
| Generate pilot safety data of telemonitoring and CURATE.AI-assisted dose titration protocol. | The composite of hospitalizations due to hypotension, bradycardia, hyperkalemia, or acute kidney injury. | 3 months |