Clinical Evaluation of the Nova Max Pro Statsensor Point of Care Creatinine Measuring Device in the Clinical Outpatient and Home Setting & Assessment of the Patient Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Coefficient of variation (CV) calculated from repeated creatinine measures taken from the Nova Max Pro creatinine analyser and reference laboratory method over the duration of the study
研究概览
简要总结
Blood creatinine is an important biomarker used to monitor kidney function. In patients with chronic kidney disease or patients who have received a kidney transplant, careful and frequent monitoring of kidney function is required to enable timely intervention in the event of deteriorating kidney function. Indeed, following kidney transplantation, patients may have their blood serum creatinine checked on average 20 times, during the first year post-transplantation to monitor for graft rejection.
In current clinical practice, most blood creatinine assessments (blood tests) are undertaken in the primary care GP clinics or hospital settings. This practice places burden on healthcare resources and may delay the early detection of deteriorating kidney function. It also places additional burden on patients and impact's their lives as patients are required to attend frequent clinic appointments and undertake regular blood tests. Therefore, the ability for individuals to remotely self-monitor their own kidney function would have a number of health and socio-economic related benefits.
Currently the study will evaluate the clinical usefulness and reliability of a handheld point of care creatinine monitoring device called the Nova Max Pro StatSensor device, in patients who have recently received a kidney transplant. The aim is to compare the clinical performance (i.e accuracy and precision) of the device, with standard laboratory based measurements for measuring blood creatinine levels, in 100 transplant patients attending the outpatient clinic. All patients will be enrolled in the study for a period of 12-weeks. As part of the nested sub-study, 30 participants will measuring their creatinine levels using the Nova Max Pro StatSensor device at home, on the morning of their outpatient clinic. the study will assess the patients experience and attitude towards using the device via a questionnaire and structured interview at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18-year-old
- •Able to provide informed consent
- •Receipt of a renal transplant
- •Attending the renal transplant clinic and the study site.
- •Sub-study only: Demonstrate proficiency in using the Nova Max Pro device correctly at Screening (V1) or Visit 3, if enrolling in sub-study at later date.
排除标准
- •Declined written informed consent
- •Pregnant females or females who plan to conceive during the 12-week study period.
- •History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational device, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study
研究组 & 干预措施
Main study
Assessment of capillary blood creatine levels, using the Nova Max Pro device, at the participating site, on the day of the patient's routine outpatient clinic visit and in the remote setting.
干预措施: Nova Max Pro StatSensor device (Device)
结局指标
主要结局
Coefficient of variation (CV) calculated from repeated creatinine measures taken from the Nova Max Pro creatinine analyser and reference laboratory method over the duration of the study
时间窗: Up to 12 weeks
Mean measurements & standard deviation of repeated creatinine measures taken from the Nova Max Pro creatinine analyser and reference laboratory method over the duration of the study
时间窗: Up to 12 weeks
A structured questionnaire undertaken at the end of the study will assess subjects' satisfaction and attitudes towards creatinine self-monitoring with the Nova Max Pro creatinine analyser.
时间窗: Up to 12 weeks
A structured interview undertaken at the end of the study will assess subjects' satisfaction and attitudes towards creatinine self-monitoring with the Nova Max Pro creatinine analyser.
时间窗: Up to 12 weeks
次要结局
- Coefficient of variation calculated from repeated creatinine measures taken from the Nova Max Pro creatinine analyser and local laboratory over the study period. Results from outpatient and remote settings will be analysed together and separately.(Up to 12 weeks)
- Mean measurements & standard deviation of repeated creatinine measures taken from the Nova Max Pro device and reference laboratory method over the duration of the study(Up to 12 weeks)
- Assessed by determining the concordance correlation coefficient for Nova Max Pro creatinine analyser compared with measurements obtained by the laboratory reference methods. Measurements obtained in outpatient and remote settings will be analysed(Up to 12 weeks)
- R2 and Intraclass correlation coefficient (ICC) for repeated measurements from the Nova Max Pro creatinine analyser.(Up to 12 weeks)