Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol

Abstract

Introduction

Adults with chronic kidney disease (CKD) experience a wide range of symptoms that significantly lower their health-related quality of life (HRQoL). Using mobile-based applications for symptom assessment and management has the potential to alleviate the symptom burden of CKD and improve patient outcomes.

Methods and analysis

This is a randomised feasibility trial to assess the feasibility, acceptability, usability and potential effects of a remote symptom assessment and management (SAM-CKD) 6 week programme delivered via a mobile application. Adults aged 18 years or older with CKD grade 4 or 5 (including those on dialysis) will be randomly assigned to the SAM-CKD programme or usual care. Primary outcomes assess the intervention’s feasibility, acceptability and usability. Secondary outcomes are changes in CKD symptoms and HRQoL between baseline, 3 weeks and 6 weeks later. Data analysis involves descriptive and intention-to-treat analyses. The study will be undertaken between December 2025 and March 2026. The findings will inform whether an effective trial is feasible and whether the study design and/or its methods need modification.

Ethics and dissemination

Ethical approval was granted by the Vin University and Griffith University Human Research Ethics Committee. Results will be disseminated at the participating hospital and CKD patient groups and shared via peer-reviewed publications and conference presentations.

Trial registration number

NCT07186361.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• Feasibility study evaluating the feasibility, usability and acceptability of the first mobile app–based symptom management programme for adults with chronic kidney disease in Vietnam.

• Instruments used to assess preliminary efficacy are adapted from validated measurement tools.

• Participant blinding is not applied due to the nature of the mobile app–based intervention.

• Blinded outcome assessors will be used to minimise detection bias.

Introduction

Chronic kidney disease (CKD) is one of the top 10 most common chronic diseases worldwide, affecting more than 10% of the global population.^{1 2} In Vietnam, the estimated prevalence in 2020 was 12.8% (approximately 8.74 million) of the adult population.³ As kidney function deteriorates, a wide range of symptoms is reported. Depending on the CKD grade and symptom screening tool used, the average number of symptoms reported ranges from six to thirteen.⁴,⁶ Pain, discomfort, fatigue and low energy are the most commonly reported symptoms.⁷ Increasing symptom prevalence, frequency and severity are reported by those receiving haemodialysis (HD).^{8 9} Increased symptoms are also associated with decreased health status, ability to work and health-related quality of life (HRQoL).¹⁰,¹³

Despite the burden of CKD symptoms, there is a lack of optimal interventions and practical tools for assessing and managing symptoms.^{14 15} To bridge this gap, symptom assessment and management have gained increased recognition in CKD healthcare and have become a research priority in recent years.¹⁶ Symptom assessment is a crucial initial step that enables patients to be actively involved in their care process, helps detect health problems early and facilitates efficient symptom management in a timely manner.¹⁷ Symptom management is a dynamic process in which individuals engage in health-promoting behaviours, participate in their own healthcare and monitor symptoms to achieve optimal symptom relief and improve their quality of life.^{18 19} Fostering and optimising symptom assessment and management interventions are crucial for alleviating symptom burden, preventing or delaying dialysis initiation and improving patient outcomes.^{17 20 21} Various symptom management strategies exist, including pharmacological and non-pharmacological approaches.²²,²⁴ The traditional symptom management approach applies face-to-face consultations with clinicians to develop symptom relief strategies. With the rapid advancement of technology, eHealth interventions offer innovative solutions for various symptom management strategies.^{25 26}

There is growing evidence for using eHealth in assessing and managing symptoms across various health conditions.²⁷,²⁹ A systematic review found 38 studies using various eHealth solutions for CKD symptom assessment and monitoring.³⁰ This review found that existing eHealth solutions, mostly delivered via mobile applications (apps), primarily focus on self-monitoring, data recording and providing education and information about symptoms. However, evidence about the effectiveness of mobile applications in relieving symptoms and improving HRQoL in groups with CKD remains unclear.^{27 30}

CKD-related mobile apps offer advantages, including saving time by reducing the travel time for in-person consultations with clinicians and enhancing communication between patients and healthcare providers.^{31 32} Mobile apps, however, still face several barriers to use, such as higher requirements for eHealth literacy, erroneous information and concerns about privacy and security.³³ Additionally, a lack of access to technology, user costs or the impact of health issues on the ability to engage in the technology can affect the implementation of mobile apps for CKD symptom management. Future interventions should, therefore, strive to overcome these limitations and be tailored to the needs of adults with CKD.³⁴,³⁶

Research objectives

This study aims to develop and evaluate a symptom assessment and management intervention (SAM-CKD) via a mobile app for adults with CKD. The primary objective is to assess the feasibility of conducting a trial in terms of recruitment, follow-up, data collection, and the acceptability and usability of a mobile app delivered SAM-CKD programme. The secondary objective is to evaluate any changes in CKD symptoms and HRQoL following the intervention.

Methods and analysis

Trial design

This is a randomised feasibility trial designed according to the consolidated standards of reporting trials (CONSORT) statement extension for randomised pilot and feasibility trials.³⁷ The feasibility trial protocol has been registered with ClinicalTrial.gov (NCT07186361). A flow diagram of the feasibility trial is shown in figure 1.

Figure 1. Flow diagram of the feasibility trial protocol following the consolidated standards of reporting trials statement extension for randomised pilot and feasibility trials. CKD, chronic kidney disease; SAM, symptom assessment and management.

Study setting

This trial will be conducted at E Hospital, Hanoi, Vietnam. This large metropolitan hospital operates an HD unit 6 days a week, featuring 35 HD beds and 70 dialysis sessions daily. There is also an outpatient clinic for adults with renal diseases, operating 5 days per week and seeing approximately 70 people daily. The peritoneal dialysis service provides care for 24 individuals receiving home peritoneal dialysis at this site.

Eligibility criteria

Inclusion criteria are: (1) Adults aged 18 years or above, (2) Diagnosis of CKD grade 4 or 5 and/or receiving dialysis (HD or peritoneal dialysis), (3) Ability to speak and read Vietnamese, (4) Access to an Android smartphone with internet accessibility and (5) Capacity to give informed consent to participate in this study. Those who have a medical diagnosis of cognitive impairment, psychological problems or another terminal illness (eg, cancer and advanced lung disease), who are acutely unwell, have participated in this study’s intervention development phase and/or enrolled in another trial will be excluded.

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.³⁸ The sample size for this study has been set at 50. To account for potential dropouts based on other CKD feasibility trials, the sample size has been increased by 20%.^{39 40} A total of 60 participants will be recruited.

Recruitment and consent

Patients will be approached face-to-face before, during or after their HD sessions or when attending the inpatient ward or outpatient nephrology clinic. Nephrologists and nurses will assist in identifying and referring patients who meet the study’s inclusion criteria. Patients interested in participating may contact the research team directly. A member of the research team will meet with interested individuals to provide a detailed explanation of the study. Once interest is confirmed, eligibility screening will be conducted. Eligible participants will receive a hard copy of the participant information sheet and a thorough explanation of the study. Sufficient time will be provided for questions. Those who agree to participate will be asked to sign the informed consent form.

Randomisation

Recruitment and randomisation are ongoing processes, and each new participant is assigned to a group on joining. Since the intervention in this study is newly developed, having a larger number of participants in the intervention group compared with the control group will help the lead investigator gain experience in its delivery.³⁷ Participants will be randomly assigned using random permuted blocks with an unequal allocation ratio of 2:1. The random block sizes will be 3 and 6. An online software (Sealed Envelope) will be used to create the blocked randomisation list.⁴¹

Intervention development

The SAM-CKD programme will be developed and integrated into the existing Smart Kidney app, which provides CKD diet, exercise and disease management strategies.⁴² The Smart Kidney app was developed in Vietnam through a co-design process involving adults with CKD, their family caregivers, kidney disease experts, IT developers and researchers. The app is available for Android smartphones and is free on Google Play.

The Smart Kidney app enables additional material to be added. As symptom assessment and management are missing in the existing app, embedding the SAM-CKD programme into this app will fill this gap. This approach is also cost-efficient and time-efficient, as it extends the existing digital intervention rather than building a new application. The IT team responsible for developing the Smart Kidney app will continue to support the current project.

The theory of symptom management underpins the SAM-CKD programme.^{18 43} This theory offers a valuable framework for guiding symptom assessment and management across diverse populations in clinical practice.⁴⁴ The SAM-CKD programme has three components: Introduction, Symptom Tracker and Symptom Management. Table 1 describes the app content and features. A short video explaining symptom management and how to use the SAM-CKD programme will be provided in the Introduction. The Symptom Tracker enables self-assessment and monitoring of 17 symptoms from the Integrated Palliative Outcome Scale–Renal (IPOS-Renal).⁴⁵ Symptom management strategies in the SAM-CKD programme will provide advice for each symptom. These materials are available for adults with CKD from the Conservative Kidney Management (https://ckmcare.com/), Kidney Supportive Care programmes (https://stgrenal.org.au/ and https://metronorth.health.qld.gov.au/). Approval for using these materials had been granted. The advice consists of predefined recommendations based on standard guidelines for symptom management. Some of the advice is already available in Vietnamese. Information that is not in Vietnamese will be translated into Vietnamese. All content will be reviewed by two members of the research team (who are fluent in Vietnamese) and a group of nephrology clinicians (n=3) and adults with CKD (n=2). After embedding the SAM-CKD programme into the existing app, the same team will test it to identify and correct any design problems prior to use in the feasibility trial.

Table 1. The content of the symptom assessment and management-chronic kidney disease programme and the app’s features.

Component	Description	App feature
Introduction	An introduction to the SAM-CKD programme and key messages	Welcome video: a welcome video will introduce the SAM-CKD programme, key information and important messages about symptoms, common misunderstandings about symptoms and symptom management, how to navigate the programme and other relevant information
Symptom tracker	A symptom tracker to enable self-assessment and monitoring of symptoms. A list of 17 symptoms from the IPOS-Renal questionnaire is assessed	1. Symptom tracker Participants will be encouraged to assess symptoms on their own. They can self-assess symptoms at any time based on when a symptom occurs. Patients can access the Symptom Tracker function, choose a symptom from the symptom list and select the severity levels that match their experience of the symptom Assessment results will be presented according to severity levels: red (severe, overwhelming), yellow (slight, moderate) and green (not at all) With symptoms rated, advice and recommendations will be provided
		2. Symptom diary Participants will document symptoms using text entry
		3. Notifications Daily reminders: participants will receive a reminder to self-assess their symptoms at 8:00 a.m every day Follow-up assessments: after activating their account in the app, participants in the intervention group will be prompted to complete symptom assessments at baseline, 3 week and 6 week follow-up points. If an assessment is not completed, a reminder (either in person or by phone) will be sent the following day
Symptom management	Providing advice and recommendations about how to self-manage symptoms	Participants can access educational materials in infographics providing information about the symptoms and symptom management, and resources

CKD, chronic kidney disease; IPOS, Integrated Palliative Outcome Scale; SAM, symptom assessment and management.

Intervention

The SAM-CKD intervention will be delivered over 6 weeks. Participants in both groups will be encouraged to assess their symptoms at least three times during the study (baseline, 3-week and 6-week follow-up). Those in the intervention group will be encouraged to use the app as often as needed, receiving daily reminders as notifications within the app. Users can turn off notifications if they wish. After assessing their symptoms, participants will immediately receive advice on managing them. If any patient reports a severe symptom, they will receive a pop-up message advising them to see their healthcare provider.

Intervention group

Participants in the intervention group will receive both usual care from their healthcare providers and the SAM-CKD programme for 6 weeks. After agreeing to participate in the study, participants will download and set up the app on their smartphones. For those unable to complete the setup independently, the researcher will provide assistance. Participants will receive oral instructions on how to use the app. They can also watch an introductory video embedded within the app. During the study period, if participants encounter any issues using the app, the researcher and IT team will be available to assist with troubleshooting.

Control group

Participants in the control group will receive usual care from their current healthcare team. They will receive an offer to use the SAM-CKD programme following this study.

Blinding

Due to the nature of the study intervention, neither the participants nor the researchers can be blinded. The assessors who will collect outcome data will be blinded to group assignments.

Cross-contamination

There are minimal chances of cross-contamination, even in the participants receiving HD who will be in close physical proximity to fellow patients during HD sessions. Participants in the intervention group will receive the intervention on their own personal smartphones, so any interactions between participants in different groups within the same unit are likely to be brief.

Data collection

Characteristics of participants will be collected through a structured questionnaire and by extracting information from medical records. Details of demographic and socioeconomic data, including age, gender, ethnicity, marital status, religion, educational level, employment status and income status, will be collected from participants. Information about medical history, family history, dialysis-related information and current medications will be extracted from medical records. Previous health education about symptom management and digital health literacy⁴⁶ will be assessed.

Data will be collected via an electronic form. The time frame for intervention and outcome assessment is shown in table 2. The planned start date for recruitment is December 2025, following completion of the CKD-SAM intervention development. Data collection is expected to span approximately 4 months, with the study scheduled for completion by the end of March 2026. Participants will be compensated 250 000 VND (£7 GBP) for their time on completing all study activities. A research assistant, who will be trained before commencing the study, will collect outcome data.

Table 2. Study schedule and outcome assessment.

Timepoint (week)	W0	W1	W2	W3	W4	W5	W6
Enrolment
Eligibility	√
Informed consent	√
Recruitment	√
Intervention
Intervention (SAM-CKD)
Control: usual care
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	√			√			√
HRQoL*	√			√			√

^*HRQoL: Health-related quality of life.

CKD, chronic kidney disease; SAM, symptom assessment and management.

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; Dingwall et al³⁹ Jakubowski et al⁴⁰ 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 of 25% or greater of eligible participants will be considered successful. The intervention will be considered to have a low attrition rate if fewer than 20% of participants are lost to follow-up or withdraw consent, while a completion rate of more than 80% 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 by participants in the intervention group at study end (week 6) using the Vietnamese version of the mHealth app usability questionnaire. This is an 18-item self-rated measure of mobile app usability. It has three subscales: (1) Ease of use (five items), (2) Interface and satisfaction (seven items) and (3) Usefulness (six items).⁴⁷ Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). 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. This instrument has been translated and adapted into several languages,⁴⁸,⁵⁰ showing good reliability and validity.

Secondary outcomes

This is a feasibility trial, not a test of any hypotheses. Thus, the research team does not expect any effects of the intervention in this small sample over a short duration. However, symptoms and HRQoL will be assessed as the secondary outcomes to investigate if any changes appear following the intervention and to determine the feasibility of using these instruments in preparation for a larger effective trial. The Vietnamese version of the IPOS-Renal will be used to assess CKD symptoms.⁴⁵ It has 11 items covering five components: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A list of 17 symptoms is rated on five levels (not at all, slightly, moderately, severely and overwhelming). The last four items concern information needs, satisfaction with healthcare and practical issues. The IPOS-Renal is widely used and demonstrates good reliability and validity in different populations from different countries.^{45 51} HRQoL will be assessed using the Vietnamese version of the self-reported EQ-5D-5L questionnaire.⁵²

Data analysis

RStudio V.4.4.1 software will be used to analyse data for this study. An intention-to-treat analysis will be applied; dropout occurrences and missing data will not be imputed.⁵³ Demographic and other participant characteristics will be summarised using descriptive statistics. Continuous variables will be reported as means±SD or medians and quartiles, as appropriate, while categorical variables will be presented as frequencies and percentages. Recruitment rates, retention rates, protocol adherence and attrition rates at study completion will be assessed using simple frequencies, percentages and descriptive statistics. App usage time will be reported in minutes and seconds. Linear mixed models will be used to examine differences in participant characteristics (eg, age, education level, time since diagnosis and CKD grade) in relation to app usage. Usability scores for the intervention will be measured by central tendency and spread, then reported according to the distribution.

For secondary outcomes (changes in symptoms and HRQoL), several statistical tests will be applied. The Shapiro-Wilk test will be used to assess data normality. Between-group comparisons of baseline characteristics will be performed using the χ² test or Fisher’s exact test for categorical variables and the independent t-test or Mann-Whitney U test for continuous variables. Preliminary efficacy analyses will evaluate between-group differences in changes from baseline, 3-week and 6-week follow-up using independent t-tests or the Mann-Whitney U test. Within-group differences across baseline, 3-week and 6-week follow-up will be assessed using paired t-tests, Wilcoxon Matched-Pairs tests, two-way repeated measures ANOVA or Friedman tests, depending on data normality. Statistical significance will be set at a two-sided p value ≤0.05.

Data management

Data will be collected using REDCap. All participant data will be treated confidentially and securely stored. The digital data will be stored in the Research Space provided by the university, which is password-restricted and can only be accessed by the researchers. The app’s data will be stored on a secure server associated with the original app, managed by Vin University (Hanoi, Vietnam). Hard-copy materials, such as consent forms, will be securely stored in a locked filing cabinet and accessible only to the research team. All data will be confidentially stored in accordance with the data protection and data management procedures provided by Griffith University.

Discussion

Adults with CKD experience diverse symptoms that significantly impact their HRQoL.^{7 54 55} Symptom assessment and management have a crucial role throughout the spectrum of CKD care delivery, helping detect care needs, alleviating symptom burden and improving patient outcomes.^{20 56} Aligning with the rapid growth of digital health technology, mobile app-based interventions offer potential self-management support for individuals with CKD.^{26 32} In addition to promoting symptom management strategies in nephrology care, it is essential to develop new initiatives that enhance self-management. This study is necessary as it will provide empirical evidence on the feasibility of a novel mobile app-based intervention for remotely assessing and managing CKD-related symptoms.

This study has several strengths and limitations.¹ This protocol is reported using the CONSORT extension guidelines for pilot and feasibility trials that ensure the transparency and quality of reporting trials. The primary aim of this feasibility study is to assess the practicality of the trial protocol and evaluate the usability and acceptability of the intervention. Secondary outcomes, including changes in symptoms and HRQoL, will provide preliminary signals to guide the design of subsequent research. As a feasibility study, these data are not intended to determine intervention effectiveness; rather, they will inform the development of appropriately powered future trials. Specifically, future work could involve a hybrid effectiveness–implementation multi-site trial, powered to detect clinically meaningful changes in symptom burden while simultaneously examining implementation processes across diverse settings. Embedding a qualitative component would allow in-depth exploration of participants’ lived experiences of symptom management, contextual factors influencing intervention use and perceived impacts on daily life. Such an approach would provide a comprehensive understanding of both effectiveness and real-world applicability for adults with CKD in Vietnam.

Patient and public involvement

Patients and clinicians are involved in the development phase of the study. They will review the intervention content materials, test the mobile app intervention and then provide feedback to revise it prior to the feasibility trial commencing. However, they will not be involved in the conduct of the study or dissemination of this protocol.

Ethics and dissemination

This study has obtained ethical approval from the Human Research Ethics Committee of Vin University (135/2025/CN/HDDD VMEC) and Griffith University (GU Ref No: 2025/716). This protocol has been registered in the Clinical Trial Registry (NCT07186361). Participants will be provided with written information about voluntary participation, the right to withdraw at any time, the study objectives and the involvement of the participants. Information collected from this study that can identify participants will be treated as confidential and securely stored, with access restricted to the research team only. All identifiable information will be replaced with a unique code. Any identifiable information will not be disclosed in any research publication. The results will be submitted for publication in peer-reviewed journals and disseminated through presentations at national or international conferences.