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Chronic Kidney DiseaseSAM-CKDNCT07186361

Symptom Assessment And Management For Adults With CKD In Vietnam

A study testing Symptom Assessment and Management Program (SAM-CKD) which is delivered via Smart Kidney mobile app in people with Chronic Kidney Disease, run by Griffith University at 1 site in Vietnam.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Adults with chronic kidney disease (CKD) have many symptoms that lower their quality of life and put a huge burden on the healthcare system. Recently, eHealth solutions have been introduced in chronic kidney disease care, helping with symptom management and improving patient outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Symptom Assessment and Management Program (SAM-CKD) which is delivered via Smart Kidney mobile app
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteVietnam
Study dates
1 Nov 2025to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged 18 years or above
  • are diagnosed with CKD grade 4 or grade 5 with or without haemodialysis
  • speak and read Vietnames
  • own a smartphone operating on Android with internet accessibility
  • agree to participate in this study.

Who cannot join

  • cognitive impairment
  • psychological problems
  • terminal illness, such as cancer and advanced lung disease
  • acutely unwell
  • participating in another study during this trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Khanh Linh Bui, Master of Science in Nursing contact

+61 4 1294 6780

khanhlinh.bui@griffithuni.edu.au

Vietnam1 site
  • E Hospital

    Hanoi

    Van Lan Hoang, PhD, +84 964 262 701, van.hl@vinuni.edu.vn

Other trials in Vietnam

About this study

Official title: Remote Symptom Assessment And Management Via Mobile App For Adults With Chronic Kidney Disease Living In Vietnam

Adults with chronic kidney disease (CKD) have many symptoms that lower their quality of life and put a huge burden on the healthcare system. Recently, eHealth solutions have been introduced in chronic kidney disease care, helping with symptom management and improving patient outcomes. While symptom management via electronic health (eHealth) is emerging in other countries, it has not commenced in Vietnam. This study aims to develop and evaluate a remote symptom assessment and management program delivered through a mobile application for adults with CKD living in Vietnam to help them manage their symptoms. This is the first intervention program focusing on symptom assessment and management in Vietnam. By assessing and managing symptoms, adults with CKD can better self-manage their symptoms.

Read the detailed description

Adults with CKD experience a wide range of symptoms that significantly impact their health-related quality of life 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 test a Symptom Assessment and Management (SAM-CKD) program embedded into a mobile app for adults with CKD living in Vietnam. A feasibility randomised trial will be designed in designed following the Consolidated Standards of Reporting Trials (CONSORT) statement extension for randomised pilot and feasibility trials to evaluate the feasibility, usability, acceptability, and potential effectiveness of symptoms and health-related quality of life. Adults with CKD grade 4 or 5 (including those on dialysis) will be randomly assigned to either the intervention or control groups. Informed by the Theory of Symptom Management, the intervention includes three main components: a general introduction to CKD symptoms, a symptom tracker, and symptom management strategies. The intervention group will use the program for 6 weeks to self-manage their symptoms. Primary outcomes are feasibility and acceptability, measured by eligibility rate, recruitment rate, retention and attrition, protocol adherence, mobile app usability and acceptability. Secondary outcomes are changes in CKD symptoms and health-related quality of life measured by Integrated Palliative Outcome Scale - Renal (IPOS-Renal) and European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L), respectively. Data analysis involves descriptive and intention-to-treat analyses. The results will be reported following the CONSORT statement extension for randomised pilot and feasibility trials. Findings will provide empirical evidence about the feasibility, acceptability and initial effectiveness of mobile-based symptom management intervention and will inform the design of future large-scale effectiveness studies.

Being tested
Symptom Assessment and Management Program (SAM-CKD) which is delivered via Smart Kidney mobile app
Keywords
chronic kidney disease, CKD, Symptom management, mobile app, eHealth, randomised feasibility trial, Vietnam
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.

  • Symptom Assessment and Management Program (SAM-CKD) which is delivered via Smart Kidney mobile appDevice

    An intervention program delivered through a mobile app to support symptom assessment and management for adults with CKD. The SAM-CKD program has three components - introduction, symptom tracker and symptom management. A list of 17 common symptoms will be assessed. Users 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 strategies based on symptoms reported by patients. The intervention's duration is 6 weeks.

Study groups in NCT07186361
Study groupRoleWhat they receive
Intervention group (SAM-CKD group)ExperimentalThe intervention group will be invited to use the SAM-CKD program for 6 weeks
Receives: Device: Symptom Assessment and Management Program (SAM-CKD) which is delivered via Smart Kidney mobile app
Control groupNo interventionParticipants in the control group will receive usual care and they will be offered to use the intervention after the study completes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the SAM program (Eligibility)

    The eligibility rate will be calculated by dividing the number of eligible participants by the number of screened participants. The eligibility rate will be reported in percentage.

    Measured: Baseline (week 0)

  2. Usability and Acceptability

    The usability and acceptability will be assessed after participants complete 6 weeks of intervention using the Vietnamese version of the Mobile App Usability Questionnaire. This is an 18-item self-rated measure of the usability and acceptability of mobile apps. It has three subscales: 1) ease of use (5 items), 2) interface and satisfaction (7 items), and 3) usefulness (6 items). 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 total score ranges from 18 to 126; the higher the overall total and average, the better the app's usability.

    Measured: Week 6

  3. Feasibility of the SAM program (recruitment rate)

    The recruitment rate will be calculated by dividing the number of recruited participants by the number of eligible participants and reported as percentage.

    Measured: Baseline (week 0)

  4. Feasibility of the SAM program (attrition rate)

    The attrition rate will be determined by the number of participants who drop out before completing the study and reported as percentage.

    Measured: Week 6

  5. Feasibility of the SAM program (retention rate)

    The retention rate will be calculated by the number of participants who complete the study by dividing the number of participants who enrolled. The retention rate will be reported in percentage.

    Measured: Week 6

  6. Feasibility of the SAM program (protocol adherence)

    The protocol adherence is the number of participants in the allocated group who receive the assigned intervention. The protocol adherence will be reported in percentage

    Measured: Week 6

  7. Feasibility of the SAM program (missing data)

    Missing data is the percentage of data missing from the study's reporting.

    Measured: 3 time points (week 0, week 3, week 6)

Secondary outcomes (2)
  1. Symptoms

    The Vietnamese version of Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) will be used to assess symptoms of participants in both groups. It has 11 items covering five components: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The last four items are about information needs, satisfaction with healthcare and practical issues. Items scored on a Likert scale from 0 to 4 for increasing severity; total score reflects symptom burden. The higher total score, the higher symptom burden.

    Measured: 3 time points (week 0, week 3, and week 6)

  2. Health-related quality of life

    Health-related quality of life will be assessed using a self-reported EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) Vietnamese version. The tool includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The lower score of each dimensions, the better patient's health state.

    Measured: 3 time points (week 0, week 3, and week 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants will be randomly assigned to either the intervention or control groups with allocation rate is 2:1 (2 in intervention group: 1 in control group)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186361
Sponsor's protocol ID
135/2025/CN/HDDD VMEC
Acronym
SAM-CKD
Status last verified
Sep 2025
First submitted
1 Sep 2025
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All Individual participant data (IPD) that underlie results in a publication will be shared

Publications

  • Okpechi IG, Muneer S, Ye F, Zaidi D, Ghimire A, Tinwala MM, Saad S, Osman MA, Lunyera J, Tonelli M, Caskey F, George C, Kengne AP, Malik C, Damster S, Levin A, Johnson D, Jha V, Bello AK. Global eHealth capacity: secondary analysis of WHO data on eHealth and implications for kidney care delivery in low-resource settings. BMJ Open. 2022 Mar 23;12(3):e055658. doi: 10.1136/bmjopen-2021-055658.

    PubMed 35321893
  • Marin AE, Redolat R, Gil-Gomez JA, Mesa-Gresa P. Addressing Cognitive Function and Psychological Well-Being in Chronic Kidney Disease: A Systematic Review on the Use of Technology-Based Interventions. Int J Environ Res Public Health. 2023 Feb 14;20(4):3342. doi: 10.3390/ijerph20043342.

    PubMed 36834042
  • Zhang JC, El-Majzoub S, Li M, Ahmed T, Wu J, Lipman ML, Moussaoui G, Looper KJ, Novak M, Rej S, Mucsi I. Could symptom burden predict subsequent healthcare use in patients with end stage kidney disease on hemodialysis care? A prospective, preliminary study. Ren Fail. 2020 Nov;42(1):294-301. doi: 10.1080/0886022X.2020.1744449.

    PubMed 32506997
  • van Oevelen M, Bonenkamp AA, van Eck van der Sluijs A, Bos WJW, Douma CE, van Buren M, Meuleman Y, Dekker FW, van Jaarsveld BC, Abrahams AC; DOMESTICO study group. Health-related quality of life and symptom burden in patients on haemodialysis. Nephrol Dial Transplant. 2024 Feb 28;39(3):436-444. doi: 10.1093/ndt/gfad179.

    PubMed 37580140
  • Speyer E, Tu C, Zee J, Sesso R, Lopes AA, Moutard E, Omorou AY, Stengel B, Finkelstein FO, Pecoits-Filho R, de Pinho NA, Pisoni RL; CKDopps Investigators. Symptom Burden and Its Impact on Quality of Life in Patients With Moderate to Severe CKD: The International Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps). Am J Kidney Dis. 2024 Dec;84(6):696-707.e1. doi: 10.1053/j.ajkd.2024.06.011. Epub 2024 Aug 6.

    PubMed 39117097
  • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

    PubMed 27777223
  • Bui KL, Hyun A, Purtell L, Hoang VL, Bonner A. Remote symptom assessment and management via mobile app for adults with chronic kidney disease in Vietnam (SAM-CKD programme): a randomised feasibility trial protocol. BMJ Open. 2026 Feb 6;16(2):e111934. doi: 10.1136/bmjopen-2025-111934.

    PubMed 41651513

Questions about this trial

What is this clinical trial studying?

A study testing Symptom Assessment and Management Program (SAM-CKD) which is delivered via Smart Kidney mobile app in people with Chronic Kidney Disease, run by Griffith University at 1 site in Vietnam.

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 5 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: opening soon, as of the sponsor's last update on 22 Sep 2025. 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 Vietnam. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Khanh Linh Bui, Master of Science in Nursing (+61 4 1294 6780, khanhlinh.bui@griffithuni.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the SAM program (Eligibility) (time frame: Baseline (week 0)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07186361, which also lists 7 linked publications.

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 22 Sep 2025.

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