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

NCT ID: NCT05012020

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

mHealth Remote Monitoring

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

Group Type EXPERIMENTAL

mHealth Remote Monitoring platform

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mHealth Remote Monitoring platform

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Singapore General Hospital

OTHER

Sponsor Role collaborator

AWAK Technologies Pte Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Htay Htay

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Singapore General Hospital

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SG-CLI-DOC-328

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chinese Medicine on Deferring Dialysis Initiation
NCT02194946 UNKNOWN PHASE1/PHASE2
Virtual Ward for Home Dialysis
NCT01912001 COMPLETED NA
Preventing Early Dialysis Starts
NCT02183987 COMPLETED NA