Diagnostic Accuracy, Usability, Patient Compliance, and System Reliability of the AK+ Guard™ ECG Application for Hyperkalemia Prediction in Ambulatory Chronic Kidney Disease Patients (Outpatient and Remote Monitoring Arms)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L
研究概览
简要总结
The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with chronic kidney disease (CKD).
Study objectives are:
- Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol/L) at the time of an outpatient laboratory draw.
- Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.
详细描述
The AK+ Guard™ application is an investigational Software as a Medical Device (SaMD) developed by AccurKardia, Inc. (New York, USA). It is designed to aid in the diagnosis of moderate to severe hyperkalemia (serum potassium ≥ 6.5 mmol/L) in adults using artificial intelligence analysis of Lead I electrocardiogram (ECG) data. The software is intended as a clinical decision support tool for adults at risk of hyperkalemia, including but not limited to those with end-stage renal disease (ESRD), chronic kidney disease (CKD) on renin-angiotensin-aldosterone system inhibitors, heart failure, adrenal disorders, and patients taking aldosterone synthase inhibitors. The AK+ Guard™ application analyzes only Lead I ECG signals, which may be obtained from standard 12-lead ECGs, clinical-grade ECG devices with Lead I capability, or consumer wearable devices (e.g., Apple Watch).
This pilot study is designed to generate preliminary real-world evidence on both the diagnostic performance of the application and its usability in daily life. The study includes two arms:
Arm 2A - Outpatient Diagnostic Accuracy:
- Estimate sensitivity, specificity, PPV, and NPV of AK+ Guard™ in ambulatory CKD stages III-IV
- Evaluate interoperability across selected Lead I ECG capture devices (Apple Watch, HeartBeam, and 12 lead reference)
- Characterize system reliability metrics (upload success, algorithm runtime) in the outpatient setting
Arm 2B - Remote Patient Monitoring
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Arm 2A - Outpatient Diagnostic Accuracy)
- •Age 22 years or older
- •CKD stages III-IV managed at Central Jersey Kidney Care outpatient clinic
- •Scheduled outpatient serum potassium laboratory test
- •On RAASi therapy or documented hyperkalemia (K+ ≥ 5.5 mmol/L) within the past 12 months
- •Able to provide written informed consent
- •(Arm 2B - Remote Patient Monitoring)
- •Completion of Arm 2A visit
- •Owns an iPhone compatible with the study application
- •Exclusion Criteria (Both arms):
- •Age 21 years or younger
- •Pacemaker or implantable cardioverter defibrillator
- •Pre existing Left Bundle Branch Block (LBBB), Right Bundle Branch Block (RBBB), Intraventricular Conduction Delay (IVCD), or clinically significant hypocalcemia
- •Potassium lowering treatment administered before Lead I ECG acquisition
- •Trauma, acute events, or active interventions altering potassium homeostasis
- •Physical limitation precluding ECG acquisition
排除标准
- 未提供
结局指标
主要结局
Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L
时间窗: Baseline (Day 0)
Defined as serum K+ ≥ 6.5 mmol/L
Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs)
时间窗: Daily monitoring up to 4 weeks (Day 28)
Arm 2B: (b) Mean System Usability Scale (SUS) score
时间窗: Study completion at Week 4 (Day 28)
10-item scale with final score between 0 and 100. The SUS score is an index of perceived usability (not a percentage), with higher scores indicating better usability. A score above 68 is generally considered above average usability, while lower scores suggest more usability concerns. The reported outcome will be the mean SUS score across participants.
Arm 2B: (c) Net Promoter Score (NPS)
时间窗: Study completion at Week 4 (Day 28)
Participant-reported likelihood of recommending the system to others, measured on a 0-10 scale, with higher scores indicating greater likelihood to recommend. Individual responses are converted into a Net Promoter Score (NPS), which ranges from -100 to +100. Positive values (\>0) indicate overall customer loyalty and advocacy.
次要结局
- Arm 2A: Positive Predictive Value (PPV)(Baseline (Day 0))
- Arm 2A: Negative Predictive Value (NPV)(Baseline (Day 0))
- Arm 2A: Device specific concordance(Baseline (Day 0))
- Arm 2A: Algorithm runtime(Baseline (Day 0))
- Arm 2A: Upload success rate(Baseline (Day 0))
- Arm 2B: Data completeness(Daily monitoring up to 4 weeks (Day 28))
- Arm 2B: System reliability (application ("app") crash rate, upload failure less than 2 percent (%))(Daily monitoring up to 4 weeks (Day 28))
- Arm 2B: Number of service calls per participant(Daily monitoring up to 4 weeks (Day 28))
- Arm 2B: False positive alarm rate (less than 20%)(Daily monitoring up to 4 weeks (Day 28))