Symptom Assessment And Management For Adults With CKD In Vietnam

NCT07186361 | Not Yet Recruiting

• 1 other identifier: 135/2025/CN/HDDD VMEC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; CKD; Symptom management; mobile app; eHealth; randomised feasibility trial; Vietnam

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline (week 0)

• 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.

  Week 6

• 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.

  Baseline (week 0)

• 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.

  Week 6

• 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.

  Week 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

  Week 6

• Feasibility of the SAM program (missing data)

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

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

Secondary Outcomes (2)

• Symptoms

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

• Health-related quality of life

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

Study Arms (2)

Intervention group (SAM-CKD group)

EXPERIMENTAL

The intervention group will be invited to use the SAM-CKD program for 6 weeks

Device: Symptom Assessment and Management Program (SAM-CKD) which is delivered via Smart Kidney mobile app

Control group

NO INTERVENTION

Participants in the control group will receive usual care and they will be offered to use the intervention after the study completes

Interventions

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

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.

Intervention group (SAM-CKD group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Griffith University: lead

Study Sites (1)

E Hospital

Hanoi, Vietnam

Location

Related Publications (6)

• 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.

  PMID: 35321893 BACKGROUND

• 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.

  PMID: 36834042 BACKGROUND

• 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.

  PMID: 32506997 BACKGROUND

• 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.

  PMID: 37580140 BACKGROUND

• 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.

  PMID: 39117097 BACKGROUND

• 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.

  PMID: 27777223 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Symptom Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ann Bonner, PhD

  School of Nursing and Midwifery, Griffith University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khanh Linh Bui, Master of Science in Nursing

CONTACT

+61 4 1294 6780; khanhlinh.bui@griffithuni.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study intervention, neither the patients nor the researchers can be blinded. However, the Outcome Assessor who collects study outcome data will be blinded to the group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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)

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 22, 2025
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months after publication with no end date
• Access Criteria: The IPD can be assessed underlie a publication

Locations

VN (1)