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

NCT05012020 | Completed

• 1 other identifier: SG-CLI-DOC-328
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

Digital Health; mHealth; Remote patient monitoring; Chronic care management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

Study Arms (1)

mHealth Remote Monitoring

EXPERIMENTAL

Use of the Clinic Portal by Healthcare professionals and use of the Mobile App by patients/caregivers

Device: mHealth Remote Monitoring platform

Interventions

mHealth Remote Monitoring platform DEVICE

Clinic Portal and Mobile Application for remote monitoring of Chronic Kidney Disease patients and patients on Peritoneal Dialysis

mHealth Remote Monitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AWAK Technologies Pte Ltd: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Htay Htay

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 19, 2021
• Study Start: December 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

SG (1)