Chronic Kidney DiseasesNCT05012020
Feasibility Study of a mHealth Platform for Remote Patient Monitoring of CKD and Peritoneal Dialysis Patients
A study testing mHealth Remote Monitoring platform in people with Chronic Kidney Diseases, run by AWAK Technologies Pte Ltd at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- mHealth Remote Monitoring platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- mHealth Remote Monitoring platform
- Keywords
- Digital Health, mHealth, Remote patient monitoring, Chronic care management
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Remote Monitoring platformDevice
Clinic Portal and Mobile Application for remote monitoring of Chronic Kidney Disease patients and patients on Peritoneal Dialysis
| Study group | Role | What they receive |
|---|---|---|
| mHealth Remote Monitoring | Experimental | Use of the Clinic Portal by Healthcare professionals and use of the Mobile App by patients/caregivers Receives: Device: mHealth Remote Monitoring platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Average time spent on using mobile app per day per participant
Reported as minutes per day per participant
Measured: 6 months
Secondary outcomes (9)
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)
Measured: 6 months
User experience
Measured by the mHealth app usability questionnaire (7-point likert scale with total possible score of 147)
Measured: 6 months
Pre and post study comparison of hospitalization rate
Reported as days per patient-month
Measured: 6 months
Pre and post study comparison of total number of unplanned clinic visit or emergency department visit
Measured: 6 months
Pre and post study comparison of exit-site infection rate among peritoneal dialysis patients
Reported as episode per patient-year
Measured: 6 months
Pre and post study comparison of peritonitis rate for PD patients
Reported as episode per patient-year
Measured: 6 months
Pre and Post study comparison of estimated Glomerular Filtration Rate (eGFR) for CKD patients
Measured: 6 months
Pre and Post study comparison of blood pressure measurement for CKD patients
Measured: 6 months
Pre and Post study comparison of the number of anti-hypertensive medications for CKD patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Dec 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AWAK Technologies Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Htay Htay, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012020
- Sponsor's protocol ID
- SG-CLI-DOC-328
- Status last verified
- Apr 2023
- First submitted
- 22 Jul 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05012020
- Acronym / sponsor ID
- SG-CLI-DOC-328
- Conditions
- Chronic Kidney Diseases
- Keywords
- Digital Health, mHealth, Remote patient monitoring, Chronic care management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AWAK Technologies Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- Singapore General Hospital
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mHealth Remote Monitoring | Experimental | Device: mHealth Remote Monitoring platformUse of the Clinic Portal by Healthcare professionals and use of the Mobile App by patients/caregivers |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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]
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Remote Monitoring platformClinic Portal and Mobile Application for remote monitoring of Chronic Kidney Disease patients and patients on Peritoneal Dialysis | Device | mHealth Remote Monitoring |
Primary outcome
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
Average time spent on using mobile app per day per participant
Time frame: 6 months
Reported as minutes per day per participant
9 secondary outcomes
Frequency of smart companion devices use
Time frame: 6 months
User experience
Time frame: 6 months
Pre and post study comparison of hospitalization rate
Time frame: 6 months
Pre and post study comparison of total number of unplanned clinic visit or emergency department visit
Time frame: 6 months
Pre and post study comparison of exit-site infection rate among peritoneal dialysis patients
Time frame: 6 months
Pre and post study comparison of peritonitis rate for PD patients
Time frame: 6 months
Pre and Post study comparison of estimated Glomerular Filtration Rate (eGFR) for CKD patients
Time frame: 6 months
Pre and Post study comparison of blood pressure measurement for CKD patients
Time frame: 6 months
Pre and Post study comparison of the number of anti-hypertensive medications for CKD patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Htay Htay principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Remote Monitoring platform in people with Chronic Kidney Diseases, run by AWAK Technologies Pte Ltd at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.