Feasibility Study of a Smartphone-based Patient Application and Web-based Clinic Portal Platform for Remote Patient Monitoring of Chronic Kidney Disease and Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Incidence of adherence to mobile app use as assessed by total number of participants adhering to mobile app use out of all participants.
研究概览
简要总结
The best treatment of Chronic Kidney Disease (CKD) is facilitated by early detection, when the progression of the disease can be slowed down or stopped. Early treatment focuses on diet, exercise, lifestyle changes, treating risk factors (diabetes, hypertension, etc.) and administration of medications supporting kidney functions. However, once the glomerular filtration rate dropped below 15 ml/min/1.73m2, treatment with dialysis or a kidney transplant is required. Dialysis treatments come with a huge lifestyle management and economic burden to the patients as well as the healthcare systems.
The challenges may be facilitated by usage of mobile applications that help the patients/caregivers and multidisciplinary team to manage the complexity of Peritoneal Dialysis (PD) treatment. Even though several mobile applications currently exist, they focus on certain limited aspects of health monitoring like diet or vitals and medical adherence like medication reminders. An application which would take a comprehensive all-in-one solution approach targeted towards managing kidney health is needed. The platform developed by AWAK Technologies consists of a Admin Portal, web-based Clinic Portal and a Patient Mobile Application. The App would allow patients/caregivers to enter treatment data related to their dialysis therapy, medication, symptoms and vital monitoring. It also allows them to communicate with their healthcare team via messaging and teleconsult.
The study aims to evaluate the feasibility of using this mHealth platform in the clinical setting. Additionally, the clinical investigation seeks to obtain data for further development of the mHealth platform that will better fulfil the needs of patients and healthcare professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with CKD or on PD
- •Treated at the Singapore General Hospital's Renal Clinic
- •Able to read and understand English language well enough to independently follow instructions in the App and enter data in English
- •Cognitively and physically capable and willing to interact with a digital device with internet access and perform self measurements
- •Owns a digital device with internet access [Apple/Android running on at least iPhone operating system (iOS) v13/Android v9]
排除标准
- •Living in an assisted facility, e.g., eldercare facilities, and hospices where their care is done/provided completely by healthcare professionals
- •Patients or caregivers who have no access to digital device with internet access
- •Patient has a severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good investigation candidate (i.e., other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population)
- •The patient is currently involved in another clinical investigation where that participation may conflict or interfere with the treatment, follow-up or results of this clinical investigation
结局指标
主要结局
Incidence of adherence to mobile app use as assessed by total number of participants adhering to mobile app use out of all participants.
时间窗: 6 months
Adherence is defined as use of app for ≥ 2 times on average per week for CKD patients and 7 times on average per week for PD patients
Average time spent on using mobile app per day per participant
时间窗: 6 months
Reported as minutes per day per participant
次要结局
- Frequency of smart companion devices use(6 months)
- User experience(6 months)
- Pre and post study comparison of hospitalization rate(6 months)
- Pre and post study comparison of total number of unplanned clinic visit or emergency department visit(6 months)
- Pre and post study comparison of exit-site infection rate among peritoneal dialysis patients(6 months)
- Pre and post study comparison of peritonitis rate for PD patients(6 months)
- Pre and Post study comparison of estimated Glomerular Filtration Rate (eGFR) for CKD patients(6 months)
- Pre and Post study comparison of blood pressure measurement for CKD patients(6 months)
- Pre and Post study comparison of the number of anti-hypertensive medications for CKD patients(6 months)