Remote Symptom Assessment And Management Via Mobile App For Adults With Chronic Kidney Disease Living In Vietnam
Phase: NA
Conditions: Chronic Kidney Disease
Sponsor: Griffith University

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Title: Remote symptom assessment and management via mobile app for adults with chronic 
kidney disease living in Vietnam  
Date: 16/08/2025 
This version of the study protocol has been reviewed by the Human Research Ethics 
Committee, ethics approval number 135/2025/CN/HDDD VMEC, dated 16/08/2025. 
INTRODUCTION 
Adults with chronic kidney disease (CKD) experience a wide range of symptoms that 
significantly impact their health-related quality of life (HRQoL) and place a huge burden on 
the healthcare system. Mobile health app-based interventions for symptom assessment and 
management have the potential to alleviate the burden of CKD and improve patient 
outcomes.  This study aims to develop and evaluate the feasibility of a Symptom Assessment 
and Management (SAM-CKD) program embedded into a mobile app for adults with CKD 
living in Vietnam. This study involves the development of a mobile app focusing on CKD 
symptom assessment and management, followed by a feasibility randomised trial to evaluate 
the feasibility, usability, acceptability, and potential effectiveness on symptoms and health-
related quality of life. This is the first symptom assessment and management program 
delivered via mobile app to adults with CKD in Vietnam. This study is expected to provide a 
supportive tool for those with CKD, enabling them to actively engage in their symptom 
management.  
BACKGROUND 
According to the Kidney Disease Improving Global Outcomes organisation (2024), CKD is 
characterised by abnormalities of kidney structure and function persisting for more than 3 
months and is classified into 5 grades based on glomerular filtration rate (GFR). Risk factors 
for CKD include diabetes, hypertension, obesity, cardiovascular disease, toxins/drugs, and 

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some non-modifiable factors such as genetic factors, increasing age and family history of 
CKD (Chertow et al., 2024; Tsai et al., 2016; L. Wang et al., 2023). Additionally, CKD is 
associated with impaired HRQoL, increased risks of other diseases such as cardiovascular 
disease and diabetes, increased years of life lost and premature death, and a huge burden to 
healthcare systems (Francis et al., 2024; GBD Chronic Kidney Disease Collaboration., 
2020a; Kula et al., 2023).  
The prevalence of CKD has risen dramatically and is now among the top 10 most common 
chronic diseases worldwide (Hill et al., 2016; Jager et al., 2019). In 2017, an estimated 843.6 
million individuals worldwide (11.1% of the population) had CKD, resulting in 1.2 million 
deaths (Bikbov et al., 2020; Jager et al., 2019). By 2040, CKD is predicted to become the 
fifth leading cause of mortality worldwide (Bikbov et al., 2020; Jager et al., 2019). In 
Vietnam, the estimated prevalence of CKD in 2020 was 12.8% of the population, 
approximately 8.74 million people (Thaminda et al., 2022); it was the eighth leading cause of 
death in the country (Bikbov et al., 2020).  
Due to the gradual damage to the kidney’s function, CKD often shows no obvious symptoms 
or only a few symptoms in its earlier grades (De Santo & Di Iorio, 2023). Symptoms often 
first manifest in CKD grade 4 or grade 5, by which time most of the kidney function has been 
lost (Cox et al., 2017).  The most common symptoms experienced by adults with CKD are 
fatigue, pain, poor sleep, pruritus, restless leg syndrome, sexual dysfunction, anxiety and 
depression (Clark-Cutaia et al., 2022; Gregg et al., 2021; Huang et al., 2021; Huang et al., 
2019; Jhamb et al., 2019). Symptom burden negatively impacts the HRQoL of adults with 
CKD (Speyer et al., 2024; van Oevelen et al., 2024). A higher symptom burden also predicts 
a higher risk of healthcare use (Zhang et al., 2020). Moreover, symptoms such as sleep 
disorders, chronic pain and fatigue are associated with a higher risk of mortality and adverse 
health outcomes (Yang et al., 2018). Among adults receiving kidney replacement therapy, 

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anxiety and depression have an association with haemodialysis (HD) withdrawal and a lower 
chance of eligibility for kidney transplantation (Chen et al., 2022; El-Magd et al., 2023).  
With the rapid advancement of technology, there has been an explosion of eHealth solutions 
within healthcare in recent years, and CKD is no exception (Okpechi et al., 2022). An 
increase in delivering kidney care through eHealth has been identified, even in lower-income 
countries, which offers an opportunity to enhance CKD management and improve health 
outcomes via digital health interventions (Jeddi et al., 2017; Marin et al., 2023; Okpechi et 
al., 2022). In Vietnam, existing self-management programs for adults with CKD mainly focus 
on providing knowledge about kidney disease and self-management behaviours (Nguyen et 
al., 2019). Support programs focusing on symptom assessment and management in adults 
with CKD are still limited. Research involving eHealth is just beginning with a few initiatives 
supporting CKD self-management (Lan et al., 2022). While symptom management via 
eHealth is emerging in other countries, it has not commenced in Vietnam.  
Justification for the study 
The prevalence of CKD is high in Vietnam; it is a significant health problem in the country. 
Adults with CKD have to deal with various physical, psychological and emotional symptoms 
which often interfere with usual activities, limit social interaction, and reduce capacity to 
undertake work (Fletcher et al., 2022; Gregg et al., 2021; Moore et al., 2022; Yapa et al., 
2020). The vital role of symptom management in CKD is well acknowledged, but there is 
still a lack of supporting programs to help adults better manage their CKD symptoms (Shen 
et al., 2021). Along with global trends towards remote healthcare services delivered through 
digital health technology, symptom assessment and management interventions based on 
eHealth can be a possible solution (Okpechi et al., 2022). Using CKD symptom management 
strategies delivered through eHealth has the potential to minimise the burden and 

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consequence of CKD and improve outcomes and HRQoL among adults with CKD (Curtis et 
al., 2024; Ghozali et al., 2023). However, implementing eHealth solutions focusing on CKD 
symptom assessment and management requires further study.  
RESEARCH QUESTIONS AND OBJECTIVES 
Study objectives 
To develop and evaluate the feasibility, usability, acceptability and potential effectiveness of a 
mobile app-based symptom assessment and management program for adults with CKD living 
in Vietnam.  
Research questions 
(1) Is a symptom assessment and management program delivered via a mobile app for adults 
with CKD living in Vietnam acceptable and feasible?  
Are there any changes in CKD symptoms and health-related quality of life among adults with 
CKD following the symptom assessment and management program? 
METHODS 
Study design 
A randomised feasibility trial is an appropriate approach to studying new interventions 
(Teresi et al., 2022). This study is necessary to determine important parameters such as the 
number of people eligible, the willingness of patients to be randomised, the follow-up rate, 
the response rates, and the adherence (Whitehead et al., 2014). This study can be used to 
estimate the sample size for future large-scale studies. The Consolidated Standards of 
Reporting Trials (CONSORT) statement extension for randomised pilot and feasibility trials 

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(Eldridge et al., 2016) guides this phase. The protocol of the feasibility trial will be registered 
with ClinicalTrial.gov. 
Settings 
This study will be conducted in the Department of Nephrology and Haemodialysis, and 
Outpatient Clinic, E Hospital, Hanoi, Vietnam.  
Participants 
Inclusion criteria 
Individuals aged 18 years or above who are diagnosed with CKD grade 4 or grade 5 with or 
without haemodialysis, can speak and read Vietnamese, own a smartphone operating on 
Android with internet accessibility, and agree to participate in this study. 
Exclusion criteria 
Patients with a medical diagnosis of cognitive impairment or psychological problems or 
another terminal illness, such as cancer and advanced lung disease, who are acutely unwell or 
participating in another study during this trial will be excluded from this study.  
Intervention 
The SAM-CKD intervention will be developed and embedded into an existing Smart Kidney 
app, which currently provides CKD diet, exercise and disease management strategies (Hoang 
et al., 2022). The development of the Smart Kidney app in Vietnam involved a co-design 
process with adults with CKD, their family caregivers, healthcare experts in kidney disease, 
IT developers and researchers. The app is accessible on smartphones running on the Android 
operating system and available on Google Play at no cost.  

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The Smart Kidney app enables additional material to be added. As symptom assessment and 
management are absent in the existing app, embedding the SAM-CKD program into the app 
will fill this gap. This approach is also cost- and time-efficient in extending the existing digital 
intervention rather than building a new application. The design, interface and preexisting 
features of the Smart Kidney app will remain. The IT team in charge of Smart Kidney app 
development will continue to work on the current project.  
The Theory of Symptom Management underpins the SAM-CKD program (Humphreys et al., 
2008). The SAM-CKD program has three components - introduction, symptom tracker and 
symptom management. A short introduction video explaining the symptoms and how to use 
the SAM-CKD app will be provided in the Introduction. A symptom tracker to enable self-
assessment and monitor symptoms will be offered. A list of 17 common symptoms will be 
assessed according to the IPOS-Renal instrument. Patients can self-assess symptoms and rate 
these according to the severity level (overwhelmingly, severely, moderately, slightly, and not 
at all). The SAM-CKD program will provide symptom management recommendations which 
will be adapted from the Conservative Kidney Management and Kidney Supportive Care 
programs (Conservative Kidney Management., 2024). After embedding the SAM program 
into the existing app,  it will be tested to identify design problems prior to use in the 
feasibility trial.  
Sample size  
Due to the nature of the feasibility trial, setting the sample size using a power-based 
calculation is unnecessary and there is no consensus concerning the minimum sample size 
(Whitehead et al., 2016). This study’s sample size is 50, and to allow for drop-out based on 
other CKD feasibility trials (Dingwall et al., 2021; Jakubowski et al., 2020), the sample size 
has been increased by 20%. In total, 60 participants will be recruited.  

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Research outcomes and measurements 
Primary outcomes are feasibility, usability and acceptability of the intervention. Secondary 
outcomes are changes in CKD symptoms and HRQoL following the intervention. Table 1 
illustrates the timeline for outcome assessment in this study.  
Table 1. Timeframe for outcome assessment and intervention 
Timepoint (week) 
W0 
W1 
W2 
W3 
W4 
W5 
W6 
Enrolment 
  
  
  
  
  
  
  
Eligibility 
√ 
  
  
  
  
  
  
Informed consent 
√ 
  
  
  
  
  
  
Recruitment  
√ 
  
  
  
  
  
  
Measures 
  
  
  
  
  
  
  
Demographic information 
√ 
  
  
  
  
  
  
Clinical information 
√ 
  
  
  
  
  
  
List of current medications 
√ 
  
  
  
  
  
  
Haemodialysis information 
√ 
  
  
  
  
  
  
Digital health literacy 
√ 
  
  
  
  
  
  
Attrition  
  
  
  
  
  
  
√ 
Retention 
  
  
  
  
  
  
√ 
Protocol adherence 
  
  
  
  
  
  
√ 
Missing data 
√ 
  
  
√ 
  
  
√ 
Ease of use 
  
  
  
  
  
  
√ 
Satisfaction 
  
  
  
  
  
  
√ 
Usefulness 
  
  
  
  
  
  
√ 
CKD symptoms 
√ 
  
  
√ 
  
  
√ 
Health-related quality of life 
√ 
  
  
√ 
  
  
√ 
Intervention 
  
  
  
  
  
  
  
Intervention (SAM-CKD) 
 
 
 
 
 
 
 
Control: Usual care 
 
 
 
 
 
 
 

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The sociodemographic information of participants will be collected through a structured 
questionnaire in electronic form. Details of demographic information include age, gender, 
ethnicity, marital status, religion, education level, employment, and income status. In 
addition, information about medical history, family history, haemodialysis-related 
information, a list of current medications, previous health education about symptom 
management, and digital health literacy will be assessed.  
Primary outcomes 
Feasibility will be measured by eligibility, recruitment, retention, attrition, protocol adherence, 
and missing data. The eligibility rate will be calculated by dividing the number of eligible 
participants by the number of screened participants. An eligibility rate of 70% or higher based 
on previous studies (Chan et al., 2016; Dingwall et al., 2021; Gabbard et al., 2021; Jakubowski 
et al., 2020) will be set. The recruitment rate will be calculated by dividing the number of 
recruited participants by the number of eligible participants. A recruitment rate equal to or 
greater than 25% of eligible participants will be considered successful. The intervention will 
be considered to have low attrition if less than 20% of participants are lost to follow-up or 
withdraw consent, while >80% completion will be considered a high retention rate. Protocol 
adherence is the percentage of participants in the allocated group who receive the assigned 
intervention. The protocol adherence rate is set at over 80% of participants in the allocated 
group receiving the allocated intervention.  
The usability and acceptability will be assessed after participants complete 6 weeks of 
intervention using the Vietnamese version of the Mobile App Usability Questionnaire. The 
app's usability is determined by the total and average of all statements; the higher the overall 
average, the better the app's usability. The instrument to measure app usability will be 
completed in week 6.  

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Secondary outcomes 
Participants will be asked to assess their symptoms and HRQoL three times during the study: 
week 0, week 3 and week 6. The Vietnamese version of IPOS-Renal will be used to assess 
symptoms. HRQoL will be assessed using a self-reported EQ-5D-5L Vietnamese version 
(Mai et al., 2020).  
Recruitment 
Participants will be recruited face-to-face at the point of care during their HD sessions or 
CKD outpatient clinic appointments. Participant information sheet describing the study will 
be distributed in the outpatient department, inpatient wards and the haemodialysis unit of E 
Hospital. Nephrologists and nurses in the Department of Nephrology and Dialysis will assist 
in referring patients who meet the inclusion criteria to the study by distributing the flyers to 
potential participants. The investigator will approach patients in person to invite them to 
participate in the study. If a patient shows interest in participating in the study, the researcher 
will schedule a meeting to screen potential participants using selection criteria. At the 
meeting, the investigator will confirm their interest, determine if the patient is eligible for the 
study, explain the study in detail and provide enough time for the patient to ask questions 
about the research. If potential participants agree to participate, they will be requested to 
provide their consent in written form. If participants have any further questions, they can 
contact the investigator  using the contact details in the information sheet.   
Data collection 
A research assistant will assist in collecting outcome data. A training manual will be 
developed, and in-person training will be provided. The research assistant will be trained to 
collect outcome data. During the data collection, the researchers will monitor the process to 
ensure the research assistant adheres to the manual.  

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Information will be collected via self-report at three different time points: baseline at week 0 
(T1), week 3 (T2) and after 6 weeks (T3). Data will be collected using patient-reported 
outcome measures by validated instruments, including IPOS-Renal, EQ-5D-5L, and Mobile 
App Usability Questionnaire, through an electronic form. Participants will be compensated 
$15AUD for their time upon completing the study. 
Allocation 
The recruitment and randomisation of this study will be ongoing processes where each new 
participant will be assigned a group when they join. After enrollment and completion of 
baseline assessments, participants will be randomised with a 2:1 allocation ratio, using a 
randomly permuted block randomisation (Matts & Lachin, 1988). The random sizes block of 
3 and 6 will be used. An online software named Sealed Envelope will be used to create the 
blocked randomisation list (Sealed Envelope Ltd., 2024).  
Blinding 
Due to the nature of the study intervention, neither the patients nor the researchers can be 
blinded. The research assistant who collects study outcome data will be blinded to the group 
assignment.  
Data analysis 
RStudio version 4.4.1 software will be used to analyse data for this study. Intention-to-treat 
analysis will be applied in this study (McCoy, 2017). Descriptive statistics will be applied to 
analyse demographic characteristics. Means and medians will describe continuous variables 
and percentages and frequencies will describe categorical variables, where appropriate. The 
feasibility of the trial will be measured by recruitment, retention and completion rates, which 
will be calculated and reported as percentages. Usability scores of the SAM-CKD program 
will be measured by central tendency and spread and reported depending on distribution. The 

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secondary outcomes will determine whether there are any changes in symptoms and HRQoL 
following the intervention. The homogeneity of participants in the intervention and control 
group will be tested using Chi-square, Fisher’s exact test, and independent t-test depending 
on the data categories. Depending on the distribution of data, independent t-tests or the 
Mann-Whitney U test will be used to determine the differences between the intervention and 
control groups. Paired t-tests, Wilcoxon Matched Pairs tests, repeated measures ANOVA or 
Friedman tests will be used to determine differences within each group at three assessment 
time points. Bonferroni correction will be used as a post hoc test to counteract the multiple 
comparisons after repeated measured ANOVA and Friedman tests. The significance level will 
be set at α = 0.05.  
Data management 
All data will be managed using the secure web application REDCap. Information collected 
from this study that can identify study participants will be treated as confidential and securely 
stored. The digital data will be stored in Griffith University Research Space with a password 
and can only be accessed by the researchers. The data stored on the server can only be 
accessed by the research team with the principal investigator's approval. Hard copy materials 
will be securely stored in a locked filing cabinet and can only be accessed by the research 
team. Any identifiable information will not be disclosed in any research publication. All 
materials related to this research will be kept confidential for at least 15 years from the 
publication of the results, as per national requirements, and then disposed of by secure 
destruction methods.  
Ethics considerations 
There are no foreseeable risks or harm that may occur with participation in this study. If any 
of the questions cause distress, study participants can choose not to answer those questions. 

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To minimise any burden or inconvenience on those involved in this study, for example, the 
time they will need to spend to participate in the study, participants will be encouraged to use 
the app intervention as they want, without compulsory time allocation. Participants will be 
informed that their participation is voluntary and they can withdraw anytime without any 
reason or disadvantages.  
The Human Research Ethics Committee at Vin University (Vietnam) and Griffith University 
(Australia) provided ethical approval for this study. Participants are provided with written 
information about voluntary participation, the right to withdraw at any time, the objectives of 
this study, the amount of time required when deciding to participate in this study, and what 
they would need to do during the study period. The participants will be invited to provide 
written consent before participating in the study. 
DECLARATION OF INTEREST 
The research team members declare that we have no conflict of interest in this study. 

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