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

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
mHealth Remote Monitoring platform
Sponsored by
AWAK Technologies Pte Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Diseases focused on measuring Digital Health, mHealth, Remote patient monitoring, Chronic care management

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mHealth Remote Monitoring

Arm Description

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

Outcomes

Primary Outcome Measures

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
Average time spent on using mobile app per day per participant
Reported as minutes per day per participant

Secondary Outcome Measures

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)
User experience
Measured by the mHealth app usability questionnaire (7-point likert scale with total possible score of 147)
Pre and post study comparison of hospitalization rate
Reported as days per patient-month
Pre and post study comparison of total number of unplanned clinic visit or emergency department visit
Pre and post study comparison of exit-site infection rate among peritoneal dialysis patients
Reported as episode per patient-year
Pre and post study comparison of peritonitis rate for PD patients
Reported as episode per patient-year
Pre and Post study comparison of estimated Glomerular Filtration Rate (eGFR) for CKD patients
Pre and Post study comparison of blood pressure measurement for CKD patients
Pre and Post study comparison of the number of anti-hypertensive medications for CKD patients

Full Information

First Posted
July 22, 2021
Last Updated
April 5, 2023
Sponsor
AWAK Technologies Pte Ltd
Collaborators
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05012020
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AWAK Technologies Pte Ltd
Collaborators
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Digital Health, mHealth, Remote patient monitoring, Chronic care management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mHealth Remote Monitoring
Arm Type
Experimental
Arm Description
Use of the Clinic Portal by Healthcare professionals and use of the Mobile App by patients/caregivers
Intervention Type
Device
Intervention Name(s)
mHealth Remote Monitoring platform
Intervention Description
Clinic Portal and Mobile Application for remote monitoring of Chronic Kidney Disease patients and patients on Peritoneal Dialysis
Primary Outcome Measure Information:
Title
Incidence of adherence to mobile app use as assessed by total number of participants adhering to mobile app use out of all participants.
Description
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
Time Frame
6 months
Title
Average time spent on using mobile app per day per participant
Description
Reported as minutes per day per participant
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Frequency of smart companion devices use
Description
Assessed by average number of smart device use per week per participant (reported as frequency per week per participant)
Time Frame
6 months
Title
User experience
Description
Measured by the mHealth app usability questionnaire (7-point likert scale with total possible score of 147)
Time Frame
6 months
Title
Pre and post study comparison of hospitalization rate
Description
Reported as days per patient-month
Time Frame
6 months
Title
Pre and post study comparison of total number of unplanned clinic visit or emergency department visit
Time Frame
6 months
Title
Pre and post study comparison of exit-site infection rate among peritoneal dialysis patients
Description
Reported as episode per patient-year
Time Frame
6 months
Title
Pre and post study comparison of peritonitis rate for PD patients
Description
Reported as episode per patient-year
Time Frame
6 months
Title
Pre and Post study comparison of estimated Glomerular Filtration Rate (eGFR) for CKD patients
Time Frame
6 months
Title
Pre and Post study comparison of blood pressure measurement for CKD patients
Time Frame
6 months
Title
Pre and Post study comparison of the number of anti-hypertensive medications for CKD patients
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Htay Htay
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

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

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