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OpenTrials
Completed

NCT Number: NCT05012020

Feasibility Study of a mHealth Platform for Remote Patient Monitoring of CKD 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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 169608

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth Remote Monitoring platform

Device

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

Primary outcomes

  1. Incidence of adherence to mobile app use as assessed by total number of participants adhering to mobile app use out of all participants.

    Time frame: 6 months

    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

  2. Average time spent on using mobile app per day per participant

    Time frame: 6 months

    Reported as minutes per day per participant

Secondary outcomes

  1. Frequency of smart companion devices use

    Time frame: 6 months

    Assessed by average number of smart device use per week per participant (reported as frequency per week per participant)

  2. User experience

    Time frame: 6 months

    Measured by the mHealth app usability questionnaire (7-point likert scale with total possible score of 147)

  3. Pre and post study comparison of hospitalization rate

    Time frame: 6 months

    Reported as days per patient-month

  4. Pre and post study comparison of total number of unplanned clinic visit or emergency department visit

    Time frame: 6 months

  5. Pre and post study comparison of exit-site infection rate among peritoneal dialysis patients

    Time frame: 6 months

    Reported as episode per patient-year

  6. Pre and post study comparison of peritonitis rate for PD patients

    Time frame: 6 months

    Reported as episode per patient-year

  7. Pre and Post study comparison of estimated Glomerular Filtration Rate (eGFR) for CKD patients

    Time frame: 6 months

  8. Pre and Post study comparison of blood pressure measurement for CKD patients

    Time frame: 6 months

  9. Pre and Post study comparison of the number of anti-hypertensive medications for CKD patients

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

AWAK Technologies Pte Ltd

Industry

Collaborators

  • Singapore General Hospital

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2021
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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