Feasibility Study of a mHealth Platform for Remote Patient Monitoring of CKD and Peritoneal Dialysis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Device: mHealth Remote Monitoring platform

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mHealth Remote Monitoring; Use of the Clinic Portal by Healthcare professionals and use of the Mobile App by patients/caregivers	Device: mHealth Remote Monitoring platform; Clinic Portal and Mobile Application for remote monitoring of Chronic Kidney Disease patients and patients on Peritoneal Dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adherence to mobile app use as assessed by total number of participants adhering to mobile app use out of all participants.	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	6 months
Average time spent on using mobile app per day per participant	Reported as minutes per day per participant	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of smart companion devices use	Assessed by average number of smart device use per week per participant (reported as frequency per week per participant)	6 months
User experience	Measured by the mHealth app usability questionnaire (7-point likert scale with total possible score of 147)	6 months
Pre and post study comparison of hospitalization rate	Reported as days per patient-month	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	Reported as episode per patient-year	6 months
Pre and post study comparison of peritonitis rate for PD patients	Reported as episode per patient-year	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

Collaborators and Investigators

• Sponsor: AWAK Technologies Pte Ltd
• Collaborators: Singapore General Hospital
• Investigators: Principal Investigator: Htay Htay, Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: mHealth; Digital Health; Remote patient monitoring; Chronic care management
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: SG-CLI-DOC-328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No