Symptom Assessment And Management For Adults With CKD In Vietnam

NCT ID: NCT07186361

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-03-01

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.

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention group (SAM-CKD group)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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 Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Griffith University

OTHER

Sponsor Role: lead

Responsible Party

Khanh Linh Bui

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Bonner, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing and Midwifery, Griffith University

Locations

E Hospital

Hanoi, , Vietnam

Countries

Vietnam

Central Contacts

Khanh Linh Bui, Master of Science in Nursing

Role: CONTACT

khanhlinh.bui@griffithuni.edu.au

+61 4 1294 6780

Facility Contacts

Van Lan Hoang, PhD

Role: primary

van.hl@vinuni.edu.vn

+84 964 262 701

References

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.

Reference Type: BACKGROUND

PMID: 35321893 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36834042 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32506997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37580140 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39117097 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27777223 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

135/2025/CN/HDDD VMEC

Identifier Type: -

Identifier Source: org_study_id