Clinical trial NCT05012020: Feasibility Study of a mHealth Platform for Remote Patient Monitoring of CKD and Peritoneal Dialysis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Digital Health
mHealth
Remote patient monitoring
Chronic care management
Lead sponsor: AWAK Technologies Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: Singapore General Hospital
First posted: 2021-08-19
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 \[Apple/Android running on at least iPhone operating system (iOS) v13/Android v9\]

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of adherence to mobile app use as assessed by total number of participants adhering to mobile app use out of all participants.
timeFrame: 6 months
measure: Average time spent on using mobile app per day per participant
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of smart companion devices use
timeFrame: 6 months
measure: User experience
timeFrame: 6 months
measure: Pre and post study comparison of hospitalization rate
timeFrame: 6 months
measure: Pre and post study comparison of total number of unplanned clinic visit or emergency department visit
timeFrame: 6 months
measure: Pre and post study comparison of exit-site infection rate among peritoneal dialysis patients
timeFrame: 6 months
measure: Pre and post study comparison of peritonitis rate for PD patients
timeFrame: 6 months
measure: Pre and Post study comparison of estimated Glomerular Filtration Rate (eGFR) for CKD patients
timeFrame: 6 months
measure: Pre and Post study comparison of blood pressure measurement for CKD patients
timeFrame: 6 months
measure: Pre and Post study comparison of the number of anti-hypertensive medications for CKD patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Htay Htay
role: PRINCIPAL_INVESTIGATOR
References: